Trial Outcomes & Findings for A Study to Learn About the Study Medicine Called CTB+AVP in Healthy Adult People. (NCT NCT05554237)
NCT ID: NCT05554237
Last Updated: 2024-10-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
42 participants
Primary outcome timeframe
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
Results posted on
2024-10-10
Participant Flow
A total of 42 participants (8 in Part 1 and 34 in Part 2) were enrolled in the study. The study was conducted at 1 site in Belgium.
Participant milestones
| Measure |
CTB400+AVP900mg/CTB 800+AVP1350 mg /CTB800mg/ CTB1200+AVP1350 mg/Placebo for CTB 1600mg(Part1)
Healthy participants were administered a single oral dose of ceftibuten(CTB) 400 milligrams (mg) along with Avibactam Prodrug (AVP) 900 mg on Day 1 of Period 1 followed by a single oral dose of CTB 800 mg along with AVP 1350 mg on Day 1 of Period 2. Participants received a single oral dose of CTB 800 mg alone on Day 1 of Period 3 followed by CTB 1200 mg with AVP 1350 mg and placebo for CTB 1600 mg orally on Day 1 of Period 4 and 5 respectively. There was a washout period of minimum 3 days between doses.
|
CTB400+AVP900mg /CTB800+AVP1350mg /CTB 800mg/Placebo for CTB1200+AVP1350 mg /CTB1600 mg(Part1)
Healthy participants were administered a single oral dose of CTB 400 mg along with AVP 900 mg on Day 1 of Period 1 followed by a single oral dose of CTB 800 mg along with AVP 1350 mg on Day 1 of Period 2. Participants received a single oral dose of CTB 800 mg alone on Day 1 of Period 3 followed by a placebo of CTB 1200 mg along with AVP 1350 mg and CTB 1600 mg orally on Day 1 of Period 4 and 5 respectively. There was a washout period of minimum 3 days between doses.
|
CTB400+AVP900mg/ Placebo for CTB800+AVP1350mg/ Placebo CTB800mg/ CTB1200+AVP1350mg/ CTB1600mg(Part1)
Healthy participants were administered a single oral dose of CTB 400 mg along with AVP 900 mg on Day 1 of Period 1 followed by a single oral dose of placebo for CTB 800 mg along with AVP 1350 mg on Day 1 of Period 2. Participants received a single oral dose of placebo for CTB 800 mg alone on Day 1 of Period 3 followed by CTB 1200 mg along with AVP 1350 mg and CTB 1600 mg orally on Day 1 of Period 4 and 5 respectively. There was a washout period of minimum 3 days between doses.
|
Placebo for CTB400+AVP900mg/ CTB 800+AVP1350mg/ CTB800mg/ CTB1200mg+AVP1350mg/ CTB1600mg(Part1)
Healthy participants were administered a single oral dose of placebo for CTB 400 mg along with AVP 900 mg on Day 1 of Period 1 followed by a single oral dose of CTB 800 mg along with AVP 1350 mg on Day 1 of Period 2. Participants received a single oral dose of CTB 800 mg alone on Day 1 of Period 3 followed by CTB 1200 mg along with AVP 1350 mg and CTB 1600 mg orally on Day 1 of Period 4 and 5 respectively. There was a washout period of minimum 3 days between doses.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
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Placebo for CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
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Part 1: Period 1 Treatment (1 Day)
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Part 1: Period 2 Treatment (1 Day)
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Part 1: Period 2 Washout (3 Days)
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Part 1: Period 3 Treatment (1 Day)
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Part 1: Period 3 Treatment (1 Day)
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Part 1: Period 3 Washout (3 Days)
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Part 1: Period 4 Treatment (1 Day)
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Part 1: Period 4 Treatment (1 Day)
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Part 1: Period 4 Washout (3 Days)
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Part 1: Period 4 Washout (3 Days)
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Part 1: Period 4 Washout (3 Days)
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Part 1: Period 5 Treatment (1 Day)
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Part 1: Period 5 Treatment (1 Day)
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Part 1: Period 5 Treatment (1 Day)
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Part 2 (7 Days)
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Part 2 (7 Days)
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Part 2 (7 Days)
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Reasons for withdrawal
| Measure |
CTB400+AVP900mg/CTB 800+AVP1350 mg /CTB800mg/ CTB1200+AVP1350 mg/Placebo for CTB 1600mg(Part1)
Healthy participants were administered a single oral dose of ceftibuten(CTB) 400 milligrams (mg) along with Avibactam Prodrug (AVP) 900 mg on Day 1 of Period 1 followed by a single oral dose of CTB 800 mg along with AVP 1350 mg on Day 1 of Period 2. Participants received a single oral dose of CTB 800 mg alone on Day 1 of Period 3 followed by CTB 1200 mg with AVP 1350 mg and placebo for CTB 1600 mg orally on Day 1 of Period 4 and 5 respectively. There was a washout period of minimum 3 days between doses.
|
CTB400+AVP900mg /CTB800+AVP1350mg /CTB 800mg/Placebo for CTB1200+AVP1350 mg /CTB1600 mg(Part1)
Healthy participants were administered a single oral dose of CTB 400 mg along with AVP 900 mg on Day 1 of Period 1 followed by a single oral dose of CTB 800 mg along with AVP 1350 mg on Day 1 of Period 2. Participants received a single oral dose of CTB 800 mg alone on Day 1 of Period 3 followed by a placebo of CTB 1200 mg along with AVP 1350 mg and CTB 1600 mg orally on Day 1 of Period 4 and 5 respectively. There was a washout period of minimum 3 days between doses.
|
CTB400+AVP900mg/ Placebo for CTB800+AVP1350mg/ Placebo CTB800mg/ CTB1200+AVP1350mg/ CTB1600mg(Part1)
Healthy participants were administered a single oral dose of CTB 400 mg along with AVP 900 mg on Day 1 of Period 1 followed by a single oral dose of placebo for CTB 800 mg along with AVP 1350 mg on Day 1 of Period 2. Participants received a single oral dose of placebo for CTB 800 mg alone on Day 1 of Period 3 followed by CTB 1200 mg along with AVP 1350 mg and CTB 1600 mg orally on Day 1 of Period 4 and 5 respectively. There was a washout period of minimum 3 days between doses.
|
Placebo for CTB400+AVP900mg/ CTB 800+AVP1350mg/ CTB800mg/ CTB1200mg+AVP1350mg/ CTB1600mg(Part1)
Healthy participants were administered a single oral dose of placebo for CTB 400 mg along with AVP 900 mg on Day 1 of Period 1 followed by a single oral dose of CTB 800 mg along with AVP 1350 mg on Day 1 of Period 2. Participants received a single oral dose of CTB 800 mg alone on Day 1 of Period 3 followed by CTB 1200 mg along with AVP 1350 mg and CTB 1600 mg orally on Day 1 of Period 4 and 5 respectively. There was a washout period of minimum 3 days between doses.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
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Part 2 (7 Days)
Adverse Event
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Baseline Characteristics
A Study to Learn About the Study Medicine Called CTB+AVP in Healthy Adult People.
Baseline characteristics by cohort
| Measure |
CTB400+AVP900mg/CTB 800+AVP1350 mg /CTB800mg/ CTB1200+AVP1350 mg/Placebo for CTB 1600mg(Part1)
n=2 Participants
Healthy participants were administered a single oral dose of ceftibuten(CTB) 400 milligrams (mg) along with Avibactam Prodrug (AVP) 900 mg on Day 1 of Period 1 followed by a single oral dose of CTB 800 mg along with AVP 1350 mg on Day 1 of Period 2. Participants received a single oral dose of CTB 800 mg alone on Day 1 of Period 3 followed by CTB 1200 mg with AVP 1350 mg and placebo for CTB 1600 mg orally on Day 1 of Period 4 and 5 respectively. There was a washout period of minimum 3 days between doses.
|
CTB400+AVP900mg /CTB800+AVP1350mg /CTB 800mg/Placebo for CTB1200+AVP1350 mg /CTB1600 mg(Part1)
n=2 Participants
Healthy participants were administered a single oral dose of CTB 400 mg along with AVP 900 mg on Day 1 of Period 1 followed by a single oral dose of CTB 800 mg along with AVP 1350 mg on Day 1 of Period 2. Participants received a single oral dose of CTB 800 mg alone on Day 1 of Period 3 followed by a placebo of CTB 1200 mg along with AVP 1350 mg and CTB 1600 mg orally on Day 1 of Period 4 and 5 respectively. There was a washout period of minimum 3 days between doses.
|
CTB400+AVP900mg/ Placebo for CTB800+AVP1350mg/ Placebo CTB800mg/ CTB1200+AVP1350mg/ CTB1600mg(Part1)
n=2 Participants
Healthy participants were administered a single oral dose of CTB 400 mg along with AVP 900 mg on Day 1 of Period 1 followed by a single oral dose of placebo for CTB 800 mg along with AVP 1350 mg on Day 1 of Period 2. Participants received a single oral dose of placebo for CTB 800 mg alone on Day 1 of Period 3 followed by CTB 1200 mg along with AVP 1350 mg and CTB 1600 mg orally on Day 1 of Period 4 and 5 respectively. There was a washout period of minimum 3 days between doses.
|
Placebo for CTB400+AVP900mg/ CTB 800+AVP1350mg/ CTB800mg/ CTB1200mg+AVP1350mg/ CTB1600mg(Part1)
n=2 Participants
Healthy participants were administered a single oral dose of placebo for CTB 400 mg along with AVP 900 mg on Day 1 of Period 1 followed by a single oral dose of CTB 800 mg along with AVP 1350 mg on Day 1 of Period 2. Participants received a single oral dose of CTB 800 mg alone on Day 1 of Period 3 followed by CTB 1200 mg along with AVP 1350 mg and CTB 1600 mg orally on Day 1 of Period 4 and 5 respectively. There was a washout period of minimum 3 days between doses.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=2 Participants
Healthy participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 800 mg + AVP 1350 mg q8h (Part-2)
n=2 Participants
Healthy participants were administered placebo for CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 900 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
n=2 Participants
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
n=5 Participants
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
n=1 Participants
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=3 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=1 Participants
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
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Total
n=42 Participants
Total of all reporting groups
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Age, Customized
18-44 Years
|
2 Participants
n=5 Participants
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2 Participants
n=7 Participants
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1 Participants
n=5 Participants
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2 Participants
n=4 Participants
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2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=42 Participants
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2 Participants
n=42 Participants
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4 Participants
n=42 Participants
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0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=36 Participants
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30 Participants
n=24 Participants
|
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Age, Customized
45-64 Years
|
0 Participants
n=5 Participants
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0 Participants
n=7 Participants
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1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
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1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
10 Participants
n=24 Participants
|
|
Age, Customized
Not disclosed
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
|
Sex/Gender, Customized
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
3 Participants
n=24 Participants
|
|
Sex/Gender, Customized
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
37 Participants
n=24 Participants
|
|
Sex/Gender, Customized
Not disclosed
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
30 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
9 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Not disclosed
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dosePopulation: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of Cis-Ceftibuten (CTB): Part 1
|
44990 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 25
|
—
|
—
|
—
|
—
|
—
|
18170 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 24
|
25470 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 18
|
30510 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 16
|
27120 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 12
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dosePopulation: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time for Cmax (Tmax) of CTB: Part 1
|
4.01 Hours
Interval 2.02 to 4.1
|
—
|
—
|
—
|
—
|
—
|
3.21 Hours
Interval 2.12 to 4.05
|
4.03 Hours
Interval 3.03 to 4.15
|
3.50 Hours
Interval 1.5 to 4.02
|
5.05 Hours
Interval 4.03 to 6.05
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dosePopulation: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study.
AUClast was determined using the linear/log trapezoidal method.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of CTB: Part 1
|
319200 Nanogram*hours per milliliter
Geometric Coefficient of Variation 24
|
—
|
—
|
—
|
—
|
—
|
94050 Nanogram*hours per milliliter
Geometric Coefficient of Variation 18
|
154100 Nanogram*hours per milliliter
Geometric Coefficient of Variation 14
|
171800 Nanogram*hours per milliliter
Geometric Coefficient of Variation 15
|
183600 Nanogram*hours per milliliter
Geometric Coefficient of Variation 15
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dosePopulation: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study.
Dose-normalized Cmax was determined as Cmax/Dose.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Dose-Normalized Cmax (Cmax[dn]) of CTB: Part 1
|
28.12 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 25
|
—
|
—
|
—
|
—
|
—
|
45.45 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 24
|
31.83 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 18
|
38.16 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 16
|
22.61 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 12
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dosePopulation: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study.
AUClast(dn) was determined as AUClast/Dose.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Dose-Normalized AUClast (AUClast[dn]) of CTB: Part 1
|
199.6 Nanogram*hour/milliliter per milligram
Geometric Coefficient of Variation 24
|
—
|
—
|
—
|
—
|
—
|
235.2 Nanogram*hour/milliliter per milligram
Geometric Coefficient of Variation 18
|
192.9 Nanogram*hour/milliliter per milligram
Geometric Coefficient of Variation 14
|
214.9 Nanogram*hour/milliliter per milligram
Geometric Coefficient of Variation 15
|
152.9 Nanogram*hour/milliliter per milligram
Geometric Coefficient of Variation 15
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dosePopulation: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study.
AUCinf was calculated as AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf) of CTB: Part 1
|
321900 Nanogram*hour per milliliter
Geometric Coefficient of Variation 24
|
—
|
—
|
—
|
—
|
—
|
94730 Nanogram*hour per milliliter
Geometric Coefficient of Variation 18
|
155800 Nanogram*hour per milliliter
Geometric Coefficient of Variation 13
|
173200 Nanogram*hour per milliliter
Geometric Coefficient of Variation 14
|
184900 Nanogram*hour per milliliter
Geometric Coefficient of Variation 15
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dosePopulation: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study.
AUCinf(dn) was calculated as AUCinf/Dose.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Dose-Normalized AUCinf (AUCinf[dn]) of CTB: Part 1
|
200.9 Nanogram*hour/milliliter per milligram
Geometric Coefficient of Variation 24
|
—
|
—
|
—
|
—
|
—
|
236.9 Nanogram*hour/milliliter per milligram
Geometric Coefficient of Variation 18
|
194.6 Nanogram*hour/milliliter per milligram
Geometric Coefficient of Variation 13
|
216.7 Nanogram*hour/milliliter per milligram
Geometric Coefficient of Variation 14
|
153.8 Nanogram*hour/milliliter per milligram
Geometric Coefficient of Variation 15
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dosePopulation: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study.
T1/2 was calculated as loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Half-Life (t1/2) of CTB: Part 1
|
3.180 Hours
Standard Deviation 0.28817
|
—
|
—
|
—
|
—
|
—
|
3.073 Hours
Standard Deviation 0.54265
|
2.708 Hours
Standard Deviation 0.57031
|
2.908 Hours
Standard Deviation 0.53905
|
3.138 Hours
Standard Deviation 0.27600
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dosePopulation: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study.
Vz/F was calculated as Dose/(AUCinf \* kel) where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of CTB: Part 1
|
22.72 Liter
Geometric Coefficient of Variation 30
|
—
|
—
|
—
|
—
|
—
|
18.44 Liter
Geometric Coefficient of Variation 20
|
19.70 Liter
Geometric Coefficient of Variation 14
|
19.10 Liter
Geometric Coefficient of Variation 16
|
29.28 Liter
Geometric Coefficient of Variation 14
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dosePopulation: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study.
CL/F was calculated as Dose/AUCinf.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) of CTB: Part 1
|
4.973 Liter per hour
Geometric Coefficient of Variation 24
|
—
|
—
|
—
|
—
|
—
|
4.221 Liter per hour
Geometric Coefficient of Variation 18
|
5.136 Liter per hour
Geometric Coefficient of Variation 13
|
4.620 Liter per hour
Geometric Coefficient of Variation 14
|
6.492 Liter per hour
Geometric Coefficient of Variation 15
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dosePopulation: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Data is reported for CTB 400 mg + AVP 900 mg, CTB 800 mg + AVP 1350 mg and CTB 1200 mg + AVP 1350 mg arms only as only participants from these arms received AVP (AVI and HPA: metabolites of AVP).
The lower limit of quantification for AVP was 1.0 ng/mL.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of AVP, Avibactam (AVI) and Hydroxy Pivalic Acid (HPA): Part 1
AVP
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
|
Maximum Observed Concentration (Cmax) of AVP, Avibactam (AVI) and Hydroxy Pivalic Acid (HPA): Part 1
AVI
|
—
|
—
|
—
|
—
|
—
|
—
|
3856 Nanogram per milliliter
Geometric Coefficient of Variation 44
|
5955 Nanogram per milliliter
Geometric Coefficient of Variation 13
|
6714 Nanogram per milliliter
Geometric Coefficient of Variation 26
|
—
|
|
Maximum Observed Concentration (Cmax) of AVP, Avibactam (AVI) and Hydroxy Pivalic Acid (HPA): Part 1
HPA
|
—
|
—
|
—
|
—
|
—
|
—
|
1521 Nanogram per milliliter
Geometric Coefficient of Variation 33
|
2552 Nanogram per milliliter
Geometric Coefficient of Variation 14
|
2676 Nanogram per milliliter
Geometric Coefficient of Variation 36
|
—
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dosePopulation: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Data is reported for CTB 400 mg + AVP 900 mg, CTB 800 mg + AVP 1350 mg and CTB 1200 mg + AVP 1350 mg arms only as only participants from these arms received AVP (AVI and HPA: metabolites of AVP).
AUClast(dn) was determined as AUClast/Dose. The lower limit of quantification for AVP was 1.0 ng/mL.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Dose-Normalized AUClast (AUClast[dn]) of AVP, AVI and HPA: Part 1
AVP
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
NA Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
NA Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
|
Dose-Normalized AUClast (AUClast[dn]) of AVP, AVI and HPA: Part 1
AVI
|
—
|
—
|
—
|
—
|
—
|
—
|
36.10 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 33
|
40.91 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 13
|
41.67 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 19
|
—
|
|
Dose-Normalized AUClast (AUClast[dn]) of AVP, AVI and HPA: Part 1
HPA
|
—
|
—
|
—
|
—
|
—
|
—
|
37.04 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 24
|
43.89 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 11
|
43.59 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 23
|
—
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dosePopulation: Pharmacokinetic parameter analysis set. Data is reported for CTB 400 mg + AVP 900 mg, CTB 800 mg + AVP 1350 mg and CTB 1200 mg + AVP 1350 mg arms only as only participants from these arms received AVP (AVI and HPA: metabolites of AVP). Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
The lower limit of quantification for AVP was 1.0 ng/mL.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time for Cmax (Tmax) of AVP, AVI and HPA: Part 1
AVP
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Hours
Data could not be calculated as values were below limit of quantification.
|
—
|
NA Hours
Data could not be calculated as values were below limit of quantification.
|
—
|
|
Time for Cmax (Tmax) of AVP, AVI and HPA: Part 1
AVI
|
—
|
—
|
—
|
—
|
—
|
—
|
4.01 Hours
Interval 2.08 to 6.0
|
3.50 Hours
Interval 1.5 to 6.0
|
4.50 Hours
Interval 2.5 to 6.02
|
—
|
|
Time for Cmax (Tmax) of AVP, AVI and HPA: Part 1
HPA
|
—
|
—
|
—
|
—
|
—
|
—
|
4.01 Hours
Interval 1.5 to 6.0
|
4.00 Hours
Interval 1.0 to 6.0
|
4.50 Hours
Interval 2.5 to 6.02
|
—
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dosePopulation: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Data is reported for CTB 400 mg + AVP 900 mg, CTB 800 mg + AVP 1350 mg and CTB 1200 mg + AVP 1350 mg arms only as only participants from these arms received AVP (AVI and HPA: metabolites of AVP).
Dose-normalized Cmax was determined as Cmax/Dose. The lower limit of quantification for AVP was 1.0 ng/mL.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Dose-Normalized Cmax (Cmax[dn]) of AVP, AVI and HPA: Part 1
AVP
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Nanogram per milliliter per milligram
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
NA Nanogram per milliliter per milligram
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
NA Nanogram per milliliter per milligram
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
|
Dose-Normalized Cmax (Cmax[dn]) of AVP, AVI and HPA: Part 1
AVI
|
—
|
—
|
—
|
—
|
—
|
—
|
6.388 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 44
|
6.583 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 13
|
7.422 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 26
|
—
|
|
Dose-Normalized Cmax (Cmax[dn]) of AVP, AVI and HPA: Part 1
HPA
|
—
|
—
|
—
|
—
|
—
|
—
|
5.635 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 33
|
6.300 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 14
|
6.608 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 36
|
—
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dosePopulation: Pharmacokinetic parameter analysis set. Data is reported for CTB 400 mg + AVP 900 mg, CTB 800 mg + AVP 1350 mg and CTB 1200 mg + AVP 1350 mg arms only as only participants from these arms received AVP (AVI and HPA: metabolites of AVP). Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
AUClast was determined using the linear/log trapezoidal method. The lower limit of quantification for AVP was 1.0 ng/mL.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of AVP, AVI and HPA: Part 1
AVP
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Nanogram*hours per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
NA Nanogram*hours per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
NA Nanogram*hours per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
|
Area Under the Plasma Concentration Time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of AVP, AVI and HPA: Part 1
AVI
|
—
|
—
|
—
|
—
|
—
|
—
|
21760 Nanogram*hours per milliliter
Geometric Coefficient of Variation 33
|
37000 Nanogram*hours per milliliter
Geometric Coefficient of Variation 13
|
37680 Nanogram*hours per milliliter
Geometric Coefficient of Variation 19
|
—
|
|
Area Under the Plasma Concentration Time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of AVP, AVI and HPA: Part 1
HPA
|
—
|
—
|
—
|
—
|
—
|
—
|
9996 Nanogram*hours per milliliter
Geometric Coefficient of Variation 24
|
17790 Nanogram*hours per milliliter
Geometric Coefficient of Variation 12
|
17670 Nanogram*hours per milliliter
Geometric Coefficient of Variation 23
|
—
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dosePopulation: Pharmacokinetic parameter analysis set. Data is reported for CTB 400 mg + AVP 900 mg, CTB 800 mg + AVP 1350 mg and CTB 1200 mg + AVP 1350 mg arms only as only participants from these arms received AVP (AVI and HPA: metabolites of AVP). Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
AUCinf was calculated as AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf) of AVP, AVI and HPA: Part 1
AVI
|
—
|
—
|
—
|
—
|
—
|
—
|
22050 Nanogram*hours per milliliter
Geometric Coefficient of Variation 34
|
38060 Nanogram*hours per milliliter
Geometric Coefficient of Variation 13
|
38090 Nanogram*hours per milliliter
Geometric Coefficient of Variation 19
|
—
|
|
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf) of AVP, AVI and HPA: Part 1
HPA
|
—
|
—
|
—
|
—
|
—
|
—
|
10220 Nanogram*hours per milliliter
Geometric Coefficient of Variation 24
|
18440 Nanogram*hours per milliliter
Geometric Coefficient of Variation 10
|
17950 Nanogram*hours per milliliter
Geometric Coefficient of Variation 22
|
—
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dosePopulation: Pharmacokinetic parameter analysis set. Data is reported for CTB 400 mg + AVP 900 mg, CTB 800 mg + AVP 1350 mg and CTB 1200 mg + AVP 1350 mg arms only as only participants from these arms received AVP (AVI and HPA: metabolites of AVP). Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
AUCinf(dn) was calculated as AUCinf/Dose.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Dose-Normalized AUCinf (AUCinf[dn]) of AVP, AVI and HPA: Part 1
AVI
|
—
|
—
|
—
|
—
|
—
|
—
|
36.58 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 34
|
42.10 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 13
|
42.11 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 19
|
—
|
|
Dose-Normalized AUCinf (AUCinf[dn]) of AVP, AVI and HPA: Part 1
HPA
|
—
|
—
|
—
|
—
|
—
|
—
|
37.86 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 24
|
45.59 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 10
|
44.35 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 22
|
—
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dosePopulation: Pharmacokinetic parameter analysis set. Data is reported for CTB 400 mg + AVP 900 mg, CTB 800 mg + AVP 1350 mg and CTB 1200 mg + AVP 1350 mg arms only as only participants from these arms received AVP (AVI and HPA: metabolites of AVP). Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
T1/2 was calculated as loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Half-Life (t1/2) of AVP, AVI and HPA: Part 1
AVI
|
—
|
—
|
—
|
—
|
—
|
—
|
4.043 Hours
Standard Deviation 1.0748
|
5.302 Hours
Standard Deviation 1.4722
|
3.632 Hours
Standard Deviation 0.86092
|
—
|
|
Terminal Half-Life (t1/2) of AVP, AVI and HPA: Part 1
HPA
|
—
|
—
|
—
|
—
|
—
|
—
|
4.218 Hours
Standard Deviation 0.92090
|
5.347 Hours
Standard Deviation 1.5405
|
3.853 Hours
Standard Deviation 0.86710
|
—
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dosePopulation: Pharmacokinetic parameter analysis set. Data is reported for CTB 400 mg + AVP 900 mg, CTB 800 mg + AVP 1350 mg and CTB 1200 mg + AVP 1350 mg arms only as only participants from these arms received AVP (AVI and HPA: metabolites of AVP). Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Vz/F was calculated as Dose/(AUCinf \* kel) where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of AVP, AVI and HPA : Part 1
AVI
|
—
|
—
|
—
|
—
|
—
|
—
|
154.6 Liter
Geometric Coefficient of Variation 27
|
175.0 Liter
Geometric Coefficient of Variation 33
|
121.5 Liter
Geometric Coefficient of Variation 33
|
—
|
|
Apparent Volume of Distribution (Vz/F) of AVP, AVI and HPA : Part 1
HPA
|
—
|
—
|
—
|
—
|
—
|
—
|
157.6 Liter
Geometric Coefficient of Variation 24
|
163.2 Liter
Geometric Coefficient of Variation 35
|
122.7 Liter
Geometric Coefficient of Variation 36
|
—
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dosePopulation: Pharmacokinetic parameter analysis set. Data is reported for CTB 400 mg + AVP 900 mg, CTB 800 mg + AVP 1350 mg and CTB 1200 mg + AVP 1350 mg arms only as only participants from these arms received AVP (AVI and HPA: metabolites of AVP). Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
CL/F was calculated as Dose/AUCinf.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) of AVP, AVI and HPA: Part 1
AVI
|
—
|
—
|
—
|
—
|
—
|
—
|
27.35 Liter per hour
Geometric Coefficient of Variation 34
|
23.75 Liter per hour
Geometric Coefficient of Variation 13
|
23.75 Liter per hour
Geometric Coefficient of Variation 19
|
—
|
|
Apparent Clearance (CL/F) of AVP, AVI and HPA: Part 1
HPA
|
—
|
—
|
—
|
—
|
—
|
—
|
26.44 Liter per hour
Geometric Coefficient of Variation 24
|
21.92 Liter per hour
Geometric Coefficient of Variation 10
|
22.53 Liter per hour
Geometric Coefficient of Variation 22
|
—
|
PRIMARY outcome
Timeframe: From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days)Population: Safety analysis set included all participants randomly assigned to study intervention and received at least 1 dose of study intervention. Participants were analyzed according to the treatment they actually received.
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were are any untoward medical incidence in a participant during administered study intervention, whether or not these events are related to study intervention. Severe TEAEs were defined as type of AE that interrupted usual activities of daily life (ADL), or significantly affects clinical status, or may require intensive therapeutic intervention. Related TEAEs are defined as all TEAEs considered by the investigator to have at least a 'possible' relationship with the study intervention.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
n=2 Participants
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
n=6 Participants
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
n=2 Participants
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=2 Participants
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=2 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
n=2 Participants
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Severe TEAEs and Related TEAEs: Part 1
TEAEs
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Severe TEAEs and Related TEAEs: Part 1
Severe TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Severe TEAEs and Related TEAEs: Part 1
Related TEAEs
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days)Population: Safety analysis set included all participants randomly assigned to study intervention and received at least 1 dose of study intervention. Participants were analyzed according to the treatment they actually received.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were are any untoward medical incidence in a participant during administered study intervention, whether or not these events are related to study intervention.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
n=2 Participants
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
n=6 Participants
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
n=2 Participants
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=2 Participants
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=2 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
n=2 Participants
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Withdrawals Due to TEAEs: Part 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 24 hours post-dosePopulation: Safety analysis set included all participants randomly assigned to study intervention and received at least 1 dose of study intervention. Participants were analyzed according to the treatment they actually received.
The laboratory abnormalities with non-zero participants were reported and it included: monocytes or leukocytes (greater than \[\>\] 1.2\* upper limit of normal \[ULN\]), urine hemoglobin scalar (greater than or equal to \[\>=1\]) and leukocyte esterase scalar (\>=1).
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
n=2 Participants
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
n=6 Participants
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
n=2 Participants
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=2 Participants
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=2 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
n=2 Participants
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities: Part 1
Monocytes/Leukocytes
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities: Part 1
Urine Hemoglobin (Scalar)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities: Part 1
Leukocyte Esterase (Scalar)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 24 hours post-dosePopulation: Safety analysis set included all participants randomly assigned to study intervention and received at least 1 dose of study intervention. Participants were analyzed according to the treatment they actually received.
Vital signs included blood pressure and pulse rate and were measured in a supine position after approximately 5 minutes of rest for the participant. Clinically significant changes in vital signs were determined by the investigator.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
n=2 Participants
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
n=6 Participants
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
n=2 Participants
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=2 Participants
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=2 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
n=2 Participants
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities: Part 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 24 hours post-dosePopulation: Safety analysis set included all participants randomly assigned to study intervention and received at least 1 dose of study intervention. Participants were analyzed according to the treatment they actually received.
Twelve lead ECGs were collected using an ECG machine that automatically calculated heart rate and measured PR interval, QRS duration, QT interval, QT interval correct by Bazzette's formula (QTcB) and QT interval correct by Frederica formula QTcF. ECG abnormalities included: PR interval aggregate (millisecond \[msec\], maximum \[max.\] \>=300; baseline \> 200 and max. increase \>= 25 percent (%); baseline \> 200 and max. increase \>= 25%), QRS duration aggregate (msec, max \>=140; max. increase \>= 50%), QT interval aggregate (msec, value \> 500), QTCB interval aggregate and QTCF interval aggregate (msec, 450 \< max \<= 480; 480 \< max. \<= 500; max. \> 500; 30 \< max. increase \<= 60; max. increase \> 60).
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
n=2 Participants
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
n=6 Participants
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
n=2 Participants
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=2 Participants
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=2 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
n=2 Participants
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities: Part 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7Population: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Trans-CTB was measured only for CTB400 mg+AVP 1350 mg q8h arm as pre-specified in the protocol. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of Cis-CTB and Trans-CTB: Part 2
Cis-CTB Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
14610 Nanogram per milliliter
Geometric Coefficient of Variation 21
|
22730 Nanogram per milliliter
Geometric Coefficient of Variation 26
|
17270 Nanogram per milliliter
Geometric Coefficient of Variation 11
|
—
|
|
Maximum Observed Concentration (Cmax) of Cis-CTB and Trans-CTB: Part 2
Cis-CTB Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
22630 Nanogram per milliliter
Geometric Coefficient of Variation 7
|
45640 Nanogram per milliliter
Geometric Coefficient of Variation 24
|
20680 Nanogram per milliliter
Geometric Coefficient of Variation 16
|
—
|
|
Maximum Observed Concentration (Cmax) of Cis-CTB and Trans-CTB: Part 2
Cis-CTB Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
21660 Nanogram per milliliter
Geometric Coefficient of Variation 17
|
35240 Nanogram per milliliter
Geometric Coefficient of Variation 25
|
20390 Nanogram per milliliter
Geometric Coefficient of Variation 10
|
—
|
|
Maximum Observed Concentration (Cmax) of Cis-CTB and Trans-CTB: Part 2
Trans-CTB Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
834.7 Nanogram per milliliter
Geometric Coefficient of Variation 17
|
—
|
—
|
—
|
|
Maximum Observed Concentration (Cmax) of Cis-CTB and Trans-CTB: Part 2
Trans-CTB Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
1428 Nanogram per milliliter
Geometric Coefficient of Variation 12
|
—
|
—
|
—
|
|
Maximum Observed Concentration (Cmax) of Cis-CTB and Trans-CTB: Part 2
Trans-CTB Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
1641 Nanogram per milliliter
Geometric Coefficient of Variation 15
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7Population: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Trans-CTB was measured only for CTB400 mg+AVP 1350 mg q8h arm as pre-specified in the protocol. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time for Cmax (Tmax) of Cis-CTB and Trans-CTB: Part 2
Cis-CTB Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
2.54 Hours
Interval 2.03 to 4.22
|
3.53 Hours
Interval 2.03 to 4.03
|
2.53 Hours
Interval 1.53 to 6.03
|
—
|
|
Time for Cmax (Tmax) of Cis-CTB and Trans-CTB: Part 2
Cis-CTB Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
2.80 Hours
Interval 2.03 to 4.03
|
3.53 Hours
Interval 2.53 to 4.05
|
3.28 Hours
Interval 1.05 to 6.03
|
—
|
|
Time for Cmax (Tmax) of Cis-CTB and Trans-CTB: Part 2
Cis-CTB Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
2.05 Hours
Interval 1.53 to 2.53
|
2.03 Hours
Interval 1.53 to 2.55
|
2.29 Hours
Interval 1.53 to 3.03
|
—
|
|
Time for Cmax (Tmax) of Cis-CTB and Trans-CTB: Part 2
Trans-CTB Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
5.13 Hours
Interval 4.03 to 6.08
|
—
|
—
|
—
|
|
Time for Cmax (Tmax) of Cis-CTB and Trans-CTB: Part 2
Trans-CTB Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
3.54 Hours
Interval 3.03 to 4.03
|
—
|
—
|
—
|
|
Time for Cmax (Tmax) of Cis-CTB and Trans-CTB: Part 2
Trans-CTB Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
3.54 Hours
Interval 3.03 to 4.03
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 7Population: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Trans-CTB was measured only for CTB400 mg+AVP 1350 mg q8h arm as pre-specified in the protocol. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Area under the plasma concentration time profile from time zero to time tau, the dosing interval, where tau is equal to 8 hours for three times daily (TID) dosing.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Time Curve From Time Zero to Time Tau, the Dosing Interval (AUCtau) of Cis-CTB and Trans-CTB: Part 2
Cis-CTB Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
64640 Nanogram*hours per milliliter
Geometric Coefficient of Variation 14
|
113100 Nanogram*hours per milliliter
Geometric Coefficient of Variation 22
|
67730 Nanogram*hours per milliliter
Geometric Coefficient of Variation 11
|
—
|
|
Area Under the Plasma Concentration Time Curve From Time Zero to Time Tau, the Dosing Interval (AUCtau) of Cis-CTB and Trans-CTB: Part 2
Cis-CTB Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
104200 Nanogram*hours per milliliter
Geometric Coefficient of Variation 10
|
224300 Nanogram*hours per milliliter
Geometric Coefficient of Variation 23
|
93590 Nanogram*hours per milliliter
Geometric Coefficient of Variation 17
|
—
|
|
Area Under the Plasma Concentration Time Curve From Time Zero to Time Tau, the Dosing Interval (AUCtau) of Cis-CTB and Trans-CTB: Part 2
Cis-CTB Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
101900 Nanogram*hours per milliliter
Geometric Coefficient of Variation 11
|
167600 Nanogram*hours per milliliter
Geometric Coefficient of Variation 24
|
93660 Nanogram*hours per milliliter
Geometric Coefficient of Variation 8
|
—
|
|
Area Under the Plasma Concentration Time Curve From Time Zero to Time Tau, the Dosing Interval (AUCtau) of Cis-CTB and Trans-CTB: Part 2
Trans-CTB Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
4112 Nanogram*hours per milliliter
Geometric Coefficient of Variation 13
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration Time Curve From Time Zero to Time Tau, the Dosing Interval (AUCtau) of Cis-CTB and Trans-CTB: Part 2
Trans-CTB Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
8968 Nanogram*hours per milliliter
Geometric Coefficient of Variation 11
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration Time Curve From Time Zero to Time Tau, the Dosing Interval (AUCtau) of Cis-CTB and Trans-CTB: Part 2
Trans-CTB Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
10060 Nanogram*hours per milliliter
Geometric Coefficient of Variation 12
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7Population: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Trans-CTB was measured only for CTB400 mg+AVP 1350 mg q8h arm as pre-specified in the protocol. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Dose-normalized Cmax was determined as Cmax/Dose.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Dose-Normalized Cmax (Cmax[dn]) of Cis-CTB and Trans-CTB : Part 2
Cis-CTB Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
36.56 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 21
|
28.43 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 26
|
43.22 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 11
|
—
|
|
Dose-Normalized Cmax (Cmax[dn]) of Cis-CTB and Trans-CTB : Part 2
Cis-CTB Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
56.59 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 7
|
57.06 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 24
|
51.72 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 16
|
—
|
|
Dose-Normalized Cmax (Cmax[dn]) of Cis-CTB and Trans-CTB : Part 2
Cis-CTB Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
54.21 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 17
|
44.08 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 25
|
51.00 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 10
|
—
|
|
Dose-Normalized Cmax (Cmax[dn]) of Cis-CTB and Trans-CTB : Part 2
Trans-CTB Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
2.089 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 17
|
—
|
—
|
—
|
|
Dose-Normalized Cmax (Cmax[dn]) of Cis-CTB and Trans-CTB : Part 2
Trans-CTB Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
3.572 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 12
|
—
|
—
|
—
|
|
Dose-Normalized Cmax (Cmax[dn]) of Cis-CTB and Trans-CTB : Part 2
Trans-CTB Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
4.105 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 15
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7Population: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Trans-CTB was measured only for CTB400 mg+AVP 1350 mg q8h arm as pre-specified in the protocol. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Area under the plasma concentration time profile from time zero to time tau, the dosing interval, where tau is equal to 8 hours for three times daily (TID) dosing.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Dose-Normalized AUCtau (AUCtau[dn]) of Cis-CTB and Trans-CTB: Part 2
Cis-CTB Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
161.6 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 14
|
141.6 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 22
|
169.5 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 11
|
—
|
|
Dose-Normalized AUCtau (AUCtau[dn]) of Cis-CTB and Trans-CTB: Part 2
Cis-CTB Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
260.4 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 9
|
280.7 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 23
|
234.2 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 17
|
—
|
|
Dose-Normalized AUCtau (AUCtau[dn]) of Cis-CTB and Trans-CTB: Part 2
Cis-CTB Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
255.6 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 11
|
209.8 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 24
|
234.1 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 8
|
—
|
|
Dose-Normalized AUCtau (AUCtau[dn]) of Cis-CTB and Trans-CTB: Part 2
Trans-CTB Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
10.28 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 13
|
—
|
—
|
—
|
|
Dose-Normalized AUCtau (AUCtau[dn]) of Cis-CTB and Trans-CTB: Part 2
Trans-CTB Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
22.45 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 11
|
—
|
—
|
—
|
|
Dose-Normalized AUCtau (AUCtau[dn]) of Cis-CTB and Trans-CTB: Part 2
Trans-CTB Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
25.20 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 12
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7Population: Pharmacokinetic parameter analysis set. Trans-CTB was measured only for CTB400 mg+AVP 1350 mg q8h arm as pre-specified in the protocol. Trans-CTB was measured only for CTB400 mg+AVP 1350 mg q8h arm as pre-specified in the protocol. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
T1/2 was calculated as loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Half-Life (t1/2) of Cis-CTB and Trans-CTB on Day 7: Part 2
Cis-CTB Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
3.710 hours
Standard Deviation 0.47011
|
3.930 hours
Standard Deviation 0.61106
|
3.030 hours
Standard Deviation 0.32668
|
—
|
|
Terminal Half-Life (t1/2) of Cis-CTB and Trans-CTB on Day 7: Part 2
Trans-CTB Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
4.040 hours
Standard Deviation 0.84699
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7Population: Pharmacokinetic parameter analysis set. Trans-CTB was measured only for CTB400 mg+AVP 1350 mg q8h arm as pre-specified in the protocol. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Vz/F was calculated as Dose/(AUCinf \* kel) where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of Cis-CTB and Trans-CTB : Part 2
Cis-CTB Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
16.5 Liter
Geometric Coefficient of Variation 13.7
|
15.6 Liter
Geometric Coefficient of Variation NA
Geometric CV could not be calculated as only 1 participant was analyzed.
|
15.37 Liter
Geometric Coefficient of Variation 15
|
—
|
|
Apparent Volume of Distribution (Vz/F) of Cis-CTB and Trans-CTB : Part 2
Cis-CTB Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
16.5 Liter
Geometric Coefficient of Variation 13.8
|
11.5 Liter
Geometric Coefficient of Variation 8.95
|
14.8 Liter
Geometric Coefficient of Variation 11.2
|
—
|
|
Apparent Volume of Distribution (Vz/F) of Cis-CTB and Trans-CTB : Part 2
Cis-CTB Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
20.86 Liter
Geometric Coefficient of Variation 22
|
26.76 Liter
Geometric Coefficient of Variation 36
|
18.58 Liter
Geometric Coefficient of Variation 13
|
—
|
|
Apparent Volume of Distribution (Vz/F) of Cis-CTB and Trans-CTB : Part 2
Trans-CTB Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
227.5 Liter
Geometric Coefficient of Variation 25
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7Population: Pharmacokinetic parameter analysis set. Trans-CTB was measured only for CTB400 mg+AVP 1350 mg q8h arm as pre-specified in the protocol. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
CL/F was calculated as Dose/AUCinf.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) of Cis-CTB and Trans-CTB: Part 2
Cis-CTB Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
4.61 Liter per hour
Geometric Coefficient of Variation 4.45
|
4.89 Liter per hour
Geometric Coefficient of Variation NA
Geometric CV could not be calculated as only 1 participant was analyzed.
|
5.014 Liter per hour
Geometric Coefficient of Variation 10
|
—
|
|
Apparent Clearance (CL/F) of Cis-CTB and Trans-CTB: Part 2
Cis-CTB Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
3.844 Liter per hour
Geometric Coefficient of Variation 10
|
3.579 Liter per hour
Geometric Coefficient of Variation 23
|
4.283 Liter per hour
Geometric Coefficient of Variation 17
|
—
|
|
Apparent Clearance (CL/F) of Cis-CTB and Trans-CTB: Part 2
Cis-CTB Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
3.914 Liter per hour
Geometric Coefficient of Variation 11
|
4.774 Liter per hour
Geometric Coefficient of Variation 24
|
4.273 Liter per hour
Geometric Coefficient of Variation 8
|
—
|
|
Apparent Clearance (CL/F) of Cis-CTB and Trans-CTB: Part 2
Trans-CTB Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
44.85 Liter per hour
Geometric Coefficient of Variation 12
|
—
|
—
|
—
|
|
Apparent Clearance (CL/F) of Cis-CTB and Trans-CTB: Part 2
Trans-CTB Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
39.67 Liter per hour
Geometric Coefficient of Variation 12
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7Population: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
The lower limit of quantification for AVP was 1.0 ng/mL.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of AVP, AVI and HPA: Part 2
AVP Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
|
Maximum Observed Concentration (Cmax) of AVP, AVI and HPA: Part 2
AVP Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
|
Maximum Observed Concentration (Cmax) of AVP, AVI and HPA: Part 2
AVP Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
|
Maximum Observed Concentration (Cmax) of AVP, AVI and HPA: Part 2
AVI Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
6249 Nanogram per milliliter
Geometric Coefficient of Variation 25
|
5852 Nanogram per milliliter
Geometric Coefficient of Variation 12
|
4779 Nanogram per milliliter
Geometric Coefficient of Variation 27
|
—
|
|
Maximum Observed Concentration (Cmax) of AVP, AVI and HPA: Part 2
AVI Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
7940 Nanogram per milliliter
Geometric Coefficient of Variation 15
|
8676 Nanogram per milliliter
Geometric Coefficient of Variation 37
|
6159 Nanogram per milliliter
Geometric Coefficient of Variation 15
|
—
|
|
Maximum Observed Concentration (Cmax) of AVP, AVI and HPA: Part 2
AVI Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
8474 Nanogram per milliliter
Geometric Coefficient of Variation 12
|
7673 Nanogram per milliliter
Geometric Coefficient of Variation 20
|
5753 Nanogram per milliliter
Geometric Coefficient of Variation 12
|
—
|
|
Maximum Observed Concentration (Cmax) of AVP, AVI and HPA: Part 2
HPA Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
2568 Nanogram per milliliter
Geometric Coefficient of Variation 29
|
2539 Nanogram per milliliter
Geometric Coefficient of Variation 10
|
1977 Nanogram per milliliter
Geometric Coefficient of Variation 25
|
—
|
|
Maximum Observed Concentration (Cmax) of AVP, AVI and HPA: Part 2
HPA Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
3216 Nanogram per milliliter
Geometric Coefficient of Variation 28
|
3432 Nanogram per milliliter
Geometric Coefficient of Variation 35
|
2643 Nanogram per milliliter
Geometric Coefficient of Variation 20
|
—
|
|
Maximum Observed Concentration (Cmax) of AVP, AVI and HPA: Part 2
HPA Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
3986 Nanogram per milliliter
Geometric Coefficient of Variation 24
|
3817 Nanogram per milliliter
Geometric Coefficient of Variation 21
|
2707 Nanogram per milliliter
Geometric Coefficient of Variation 15
|
—
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 7Population: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Area under the plasma concentration time profile from time zero to time tau, the dosing interval, where tau is equal to 8 hours for three times daily (TID) dosing.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Time Curve From Time Zero to Time Tau, the Dosing Interval (AUCtau) of AVP, AVI and HPA: Part 2
AVI Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
29480 Nanogram*hours per milliliter
Geometric Coefficient of Variation 16
|
27920 Nanogram*hours per milliliter
Geometric Coefficient of Variation 24
|
22530 Nanogram*hours per milliliter
Geometric Coefficient of Variation 15
|
—
|
|
Area Under the Plasma Concentration Time Curve From Time Zero to Time Tau, the Dosing Interval (AUCtau) of AVP, AVI and HPA: Part 2
AVI Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
39570 Nanogram*hours per milliliter
Geometric Coefficient of Variation 14
|
45130 Nanogram*hours per milliliter
Geometric Coefficient of Variation 21
|
29920 Nanogram*hours per milliliter
Geometric Coefficient of Variation 17
|
—
|
|
Area Under the Plasma Concentration Time Curve From Time Zero to Time Tau, the Dosing Interval (AUCtau) of AVP, AVI and HPA: Part 2
AVI Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
38670 Nanogram*hours per milliliter
Geometric Coefficient of Variation 16
|
38300 Nanogram*hours per milliliter
Geometric Coefficient of Variation 19
|
25810 Nanogram*hours per milliliter
Geometric Coefficient of Variation 9
|
—
|
|
Area Under the Plasma Concentration Time Curve From Time Zero to Time Tau, the Dosing Interval (AUCtau) of AVP, AVI and HPA: Part 2
HPA Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
12310 Nanogram*hours per milliliter
Geometric Coefficient of Variation 28
|
12740 Nanogram*hours per milliliter
Geometric Coefficient of Variation 23
|
9623 Nanogram*hours per milliliter
Geometric Coefficient of Variation 22
|
—
|
|
Area Under the Plasma Concentration Time Curve From Time Zero to Time Tau, the Dosing Interval (AUCtau) of AVP, AVI and HPA: Part 2
HPA Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
17910 Nanogram*hours per milliliter
Geometric Coefficient of Variation 32
|
20020 Nanogram*hours per milliliter
Geometric Coefficient of Variation 30
|
14190 Nanogram*hours per milliliter
Geometric Coefficient of Variation 22
|
—
|
|
Area Under the Plasma Concentration Time Curve From Time Zero to Time Tau, the Dosing Interval (AUCtau) of AVP, AVI and HPA: Part 2
HPA Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
21000 Nanogram*hours per milliliter
Geometric Coefficient of Variation 22
|
20500 Nanogram*hours per milliliter
Geometric Coefficient of Variation 22
|
13790 Nanogram*hours per milliliter
Geometric Coefficient of Variation 16
|
—
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7Population: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
The lower limit of quantification for AVP was 1.0 ng/mL.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time for Cmax (Tmax) of AVP, AVI and HPA: Part 2
AVI Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
1.75 Hours
Interval 1.0 to 3.0
|
2.00 Hours
Interval 1.0 to 4.0
|
2.54 Hours
Interval 1.0 to 3.0
|
—
|
|
Time for Cmax (Tmax) of AVP, AVI and HPA: Part 2
AVP Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Hours
Data could not be calculated as values were below limit of quantification.
|
—
|
|
Time for Cmax (Tmax) of AVP, AVI and HPA: Part 2
AVI Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
4.02 Hours
Interval 2.5 to 6.0
|
4.00 Hours
Interval 2.5 to 6.0
|
4.49 Hours
Interval 1.5 to 6.02
|
—
|
|
Time for Cmax (Tmax) of AVP, AVI and HPA: Part 2
AVI Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
2.77 Hours
Interval 2.0 to 4.0
|
2.50 Hours
Interval 0.0 to 4.0
|
2.75 Hours
Interval 1.02 to 6.0
|
—
|
|
Time for Cmax (Tmax) of AVP, AVI and HPA: Part 2
HPA Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
5.02 Hours
Interval 2.5 to 6.02
|
4.00 Hours
Interval 2.5 to 6.0
|
4.49 Hours
Interval 1.5 to 6.02
|
—
|
|
Time for Cmax (Tmax) of AVP, AVI and HPA: Part 2
HPA Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
2.52 Hours
Interval 2.0 to 4.0
|
2.50 Hours
Interval 0.0 to 3.0
|
2.02 Hours
Interval 0.5 to 6.0
|
—
|
|
Time for Cmax (Tmax) of AVP, AVI and HPA: Part 2
HPA Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
1.75 Hours
Interval 0.5 to 3.0
|
2.26 Hours
Interval 1.0 to 4.0
|
2.30 Hours
Interval 1.0 to 3.0
|
—
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7Population: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Dose-normalized Cmax was determined as Cmax/Dose. The lower limit of quantification for AVP was 1.0 ng/mL.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Dose-Normalized Cmax (Cmax[dn]) of AVP, AVI and HPA: Part 2
AVP Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Nanogram per milliliter per milligram
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
NA Nanogram per milliliter per milligram
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
NA Nanogram per milliliter per milligram
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
|
Dose-Normalized Cmax (Cmax[dn]) of AVP, AVI and HPA: Part 2
AVP Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Nanogram per milliliter per milligram
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
NA Nanogram per milliliter per milligram
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
NA Nanogram per milliliter per milligram
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
|
Dose-Normalized Cmax (Cmax[dn]) of AVP, AVI and HPA: Part 2
AVP Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Nanogram per milliliter per milligram
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
NA Nanogram per milliliter per milligram
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
NA Nanogram per milliliter per milligram
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
|
Dose-Normalized Cmax (Cmax[dn]) of AVP, AVI and HPA: Part 2
AVI Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
6.907 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 25
|
6.470 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 12
|
7.927 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 27
|
—
|
|
Dose-Normalized Cmax (Cmax[dn]) of AVP, AVI and HPA: Part 2
AVI Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
8.786 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 15
|
9.587 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 37
|
10.21 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 15
|
—
|
|
Dose-Normalized Cmax (Cmax[dn]) of AVP, AVI and HPA: Part 2
AVI Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
9.373 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 12
|
8.483 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 20
|
9.544 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 12
|
—
|
|
Dose-Normalized Cmax (Cmax[dn]) of AVP, AVI and HPA: Part 2
HPA Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
6.340 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 29
|
6.270 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 10
|
7.324 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 25
|
—
|
|
Dose-Normalized Cmax (Cmax[dn]) of AVP, AVI and HPA: Part 2
HPA Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
7.939 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 28
|
8.471 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 35
|
9.782 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 20
|
—
|
|
Dose-Normalized Cmax (Cmax[dn]) of AVP, AVI and HPA: Part 2
HPA Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
9.824 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 23
|
9.430 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 21
|
10.02 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 15
|
—
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7Population: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Area under the plasma concentration time profile from time zero to time tau, the dosing interval, where tau is equal to 8 hours for three times daily (TID) dosing.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Dose-Normalized AUCtau (AUCtau[dn]) of AVP, AVI and HPA: Part 2
AVI Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
32.63 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 16
|
30.88 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 24
|
37.37 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 15
|
—
|
|
Dose-Normalized AUCtau (AUCtau[dn]) of AVP, AVI and HPA: Part 2
AVI Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
43.77 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 14
|
49.92 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 21
|
49.62 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 17
|
—
|
|
Dose-Normalized AUCtau (AUCtau[dn]) of AVP, AVI and HPA: Part 2
AVI Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
42.73 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 16
|
42.32 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 19
|
42.81 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 9
|
—
|
|
Dose-Normalized AUCtau (AUCtau[dn]) of AVP, AVI and HPA: Part 2
HPA Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
30.43 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 28
|
31.53 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 23
|
35.63 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 21
|
—
|
|
Dose-Normalized AUCtau (AUCtau[dn]) of AVP, AVI and HPA: Part 2
HPA Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
44.19 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 32
|
49.40 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 30
|
52.59 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 22
|
—
|
|
Dose-Normalized AUCtau (AUCtau[dn]) of AVP, AVI and HPA: Part 2
HPA Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
51.84 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 22
|
50.56 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 22
|
51.08 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 16
|
—
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on day 7Population: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
T1/2 was calculated as loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. The lower limit of quantification for HPA was 10.0 ng/mL.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Half-Life (t1/2) of AVP, AVI and HPA on Day 7: Part 2
AVI Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
6.473 hours
Standard Deviation 1.0929
|
8.165 hours
Standard Deviation 1.3241
|
7.150 hours
Standard Deviation 1.8379
|
—
|
|
Terminal Half-Life (t1/2) of AVP, AVI and HPA on Day 7: Part 2
HPA Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
6.270 hours
Standard Deviation 0.64211
|
NA hours
Standard Deviation NA
Data could not be calculated as values were below limit of quantification.
|
5.965 hours
Standard Deviation 1.1229
|
—
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7Population: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Vz/F was calculated as Dose/(AUCinf \* kel) where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. The lower limit of quantification for AVI and HPA was 10.0 ng/mL.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of AVP, AVI and HPA: Part 2
HPA Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
188.1 Liter
Geometric Coefficient of Variation 24
|
NA Liter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
165.9 Liter
Geometric Coefficient of Variation 9
|
—
|
|
Apparent Volume of Distribution (Vz/F) of AVP, AVI and HPA: Part 2
AVI Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
63.23 Liter
Geometric Coefficient of Variation 10
|
—
|
|
Apparent Volume of Distribution (Vz/F) of AVP, AVI and HPA: Part 2
AVI Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Liter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
58.04 Liter
Geometric Coefficient of Variation 25
|
64.02 Liter
Geometric Coefficient of Variation 22
|
—
|
|
Apparent Volume of Distribution (Vz/F) of AVP, AVI and HPA: Part 2
AVI Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
228.7 Liter
Geometric Coefficient of Variation 22
|
275.1 Liter
Geometric Coefficient of Variation 21
|
234.7 Liter
Geometric Coefficient of Variation 18
|
—
|
|
Apparent Volume of Distribution (Vz/F) of AVP, AVI and HPA: Part 2
HPA Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Liter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
|
Apparent Volume of Distribution (Vz/F) of AVP, AVI and HPA: Part 2
HPA Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Liter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
NA Liter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
PRIMARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7Population: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
CL/F was calculated as Dose/AUCinf.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=6 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) of AVP, AVI and HPA: Part 2
AVI Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
30.65 Liter per hour
Geometric Coefficient of Variation 16
|
32.38 Liter per hour
Geometric Coefficient of Variation 24
|
26.76 Liter per hour
Geometric Coefficient of Variation 15
|
—
|
|
Apparent Clearance (CL/F) of AVP, AVI and HPA: Part 2
AVI Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
22.86 Liter per hour
Geometric Coefficient of Variation 14
|
20.02 Liter per hour
Geometric Coefficient of Variation 21
|
20.13 Liter per hour
Geometric Coefficient of Variation 17
|
—
|
|
Apparent Clearance (CL/F) of AVP, AVI and HPA: Part 2
AVI Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
23.41 Liter per hour
Geometric Coefficient of Variation 16
|
23.61 Liter per hour
Geometric Coefficient of Variation 19
|
23.34 Liter per hour
Geometric Coefficient of Variation 9
|
—
|
|
Apparent Clearance (CL/F) of AVP, AVI and HPA: Part 2
HPA Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
32.89 Liter per hour
Geometric Coefficient of Variation 28
|
31.73 Liter per hour
Geometric Coefficient of Variation 23
|
28.07 Liter per hour
Geometric Coefficient of Variation 21
|
—
|
|
Apparent Clearance (CL/F) of AVP, AVI and HPA: Part 2
HPA Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
22.64 Liter per hour
Geometric Coefficient of Variation 32
|
20.25 Liter per hour
Geometric Coefficient of Variation 30
|
19.02 Liter per hour
Geometric Coefficient of Variation 22
|
—
|
|
Apparent Clearance (CL/F) of AVP, AVI and HPA: Part 2
HPA Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
19.28 Liter per hour
Geometric Coefficient of Variation 22
|
19.78 Liter per hour
Geometric Coefficient of Variation 22
|
19.59 Liter per hour
Geometric Coefficient of Variation 16
|
—
|
PRIMARY outcome
Timeframe: From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 42 days)Population: Safety analysis set included all participants randomly assigned to study intervention and received at least 1 dose of study intervention. Participants were analyzed according to the treatment they actually received.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were are any untoward medical incidence in a participant during administered study intervention, whether or not these events are related to study intervention. Severe TEAEs were defined as type of AE that interrupted usual ADL, or significantly affects clinical status, or may require intensive therapeutic intervention. Related TEAEs are defined as all TEAEs considered by the investigator to have at least a 'possible' relationship with the study intervention.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
n=2 Participants
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
n=5 Participants
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
n=1 Participants
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=3 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=1 Participants
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=2 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
n=2 Participants
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs, Severe TEAEs and Related TEAEs: Part 2
TEAEs
|
5 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With TEAEs, Severe TEAEs and Related TEAEs: Part 2
Severe TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs, Severe TEAEs and Related TEAEs: Part 2
Related TEAEs
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 42 days)Population: Safety analysis set included all participants randomly assigned to study intervention and received at least 1 dose of study intervention. Participants were analyzed according to the treatment they actually received.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were any untoward medical incidence in a participant during administered study intervention, whether or not these events are related to study intervention.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
n=2 Participants
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
n=5 Participants
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
n=1 Participants
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=3 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=1 Participants
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=2 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
n=2 Participants
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Withdrawals Due to TEAEs: Part 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From start of treatment up to Day 7Population: Safety analysis set included all participants randomly assigned to study intervention and received at least 1 dose of study intervention. Participants were analyzed according to the treatment they actually received.
The laboratory abnormalities with non-zero participants were reported and it included: neutrophils/ leukocytes (less than \[\<\] 0.8x lower limit of normal \[LLN\]), eosinophils/leukocytes (\>1.2x ULN), monocytes/leukocytes (\>1.2x ULN), bicarbonate (\>1.1x ULN), urine glucose (\>=1), ketones scalar (\>=1), urine hemoglobin scalar (\>=1), leukocyte esterase scalar (\>=1).
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
n=2 Participants
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
n=5 Participants
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
n=1 Participants
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=3 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=1 Participants
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=2 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
n=2 Participants
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities: Part 2
Neutrophils/leukocytes
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities: Part 2
Eosinophils/leukocytes
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities: Part 2
Monocytes/leukocytes
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities: Part 2
Bicarbonate
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities: Part 2
Urine glucose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities: Part 2
Ketones (scalar)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities: Part 2
Urine hemoglobin (scalar)
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities: Part 2
Leukocyte esterase (scalar)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From start of treatment up to Day 7Population: Safety analysis set included all participants randomly assigned to study intervention and received at least 1 dose of study intervention. Participants were analyzed according to the treatment they actually received.
Vital signs included blood pressure and pulse rate and were measured in a supine position after approximately 5 minutes of rest for the participant. Clinically significant changes in vital signs were determined by the investigator.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
n=2 Participants
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
n=5 Participants
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
n=1 Participants
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=3 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=1 Participants
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=2 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
n=2 Participants
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities: Part 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From start of treatment up to Day 7Population: Safety analysis set included all participants randomly assigned to study intervention and received at least 1 dose of study intervention. Participants were analyzed according to the treatment they actually received.
Twelve lead ECGs were collected using an ECG machine that automatically calculated heart rate and measured PR interval, QRS duration, QT interval, QT interval correct by Bazzette's formula (QTcB) and QT interval correct by Frederica formula QTcF. ECG abnormalities included: PR interval aggregate (millisecond \[msec\], maximum \[max.\] \>=300; baseline \> 200 and max. increase \>= 25 percent (%); baseline \> 200 and max. increase \>= 25%), QRS duration aggregate (msec, max \>=140; max. increase \>= 50%), QT interval aggregate (msec, value \> 500), QTCB interval aggregate and QTCF interval aggregate (msec, 450 \< max \<= 480; 480 \< max. \<= 500; max. \> 500; 30 \< max. increase \<= 60; max. increase \> 60).
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
n=2 Participants
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
n=5 Participants
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
n=1 Participants
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=3 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=1 Participants
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=2 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
n=6 Participants
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
n=2 Participants
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities: Part 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: anytime between 0 to 8 hours post dose on Day 6Population: Pharmacokinetic analysis set. Data was planned to be analyzed for CTB 400 mg + AVP 1350 mg arm only as pre-specified in the protocol. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Amount Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau (Aetau) of Cis-CTB, Trans-CTB, AVP, AVI and HPA: Part 2
Cis CTB Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
181.8 Milligrams
Geometric Coefficient of Variation 98
|
—
|
—
|
—
|
|
Amount Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau (Aetau) of Cis-CTB, Trans-CTB, AVP, AVI and HPA: Part 2
Trans CTB Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
48.23 Milligrams
Geometric Coefficient of Variation 54
|
—
|
—
|
—
|
|
Amount Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau (Aetau) of Cis-CTB, Trans-CTB, AVP, AVI and HPA: Part 2
AVI Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
295.6 Milligrams
Geometric Coefficient of Variation 101
|
—
|
—
|
—
|
|
Amount Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau (Aetau) of Cis-CTB, Trans-CTB, AVP, AVI and HPA: Part 2
HPA Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
22.01 Milligrams
Geometric Coefficient of Variation 51
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: anytime between 0 to 8 hours post dose on Day 6Population: Pharmacokinetic analysis set. Data was planned to be analyzed for CTB 400 mg + AVP 1350 mg arm only as pre-specified in the protocol. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Aetau% was calculated as 100\*Aetau/Dose.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percent of Dose Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau (Aetau%) of Cis-CTB, Trans-CTB, AVP, AVI and HPA: Part 2
Cis CTB Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
45.40 Percentage of dose excreted
Geometric Coefficient of Variation 98
|
—
|
—
|
—
|
|
Percent of Dose Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau (Aetau%) of Cis-CTB, Trans-CTB, AVP, AVI and HPA: Part 2
Trans CTB Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
12.08 Percentage of dose excreted
Geometric Coefficient of Variation 55
|
—
|
—
|
—
|
|
Percent of Dose Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau (Aetau%) of Cis-CTB, Trans-CTB, AVP, AVI and HPA: Part 2
AVI Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
32.68 Percentage of dose excreted
Geometric Coefficient of Variation 101
|
—
|
—
|
—
|
|
Percent of Dose Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau (Aetau%) of Cis-CTB, Trans-CTB, AVP, AVI and HPA: Part 2
HPA Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
5.434 Percentage of dose excreted
Geometric Coefficient of Variation 51
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: anytime between 0 to 8 hours post dose on Day 6Population: Pharmacokinetic analysis set. Data was planned to be analyzed for CTB 400 mg + AVP 1350 mg arm only as pre-specified in the protocol. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Aetau% was calculated as 100\*Aetau/Dose.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Renal Clearance (CLr) of Cis-CTB, Trans-CTBa, AVP, AVI and HPA: Part 2
Cis CTB Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
2.501 Liter per hour
Geometric Coefficient of Variation 27
|
—
|
—
|
—
|
|
Renal Clearance (CLr) of Cis-CTB, Trans-CTBa, AVP, AVI and HPA: Part 2
Trans CTB Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
6.657 Liter per hour
Geometric Coefficient of Variation 27
|
—
|
—
|
—
|
|
Renal Clearance (CLr) of Cis-CTB, Trans-CTBa, AVP, AVI and HPA: Part 2
AVI Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
10.61 Liter per hour
Geometric Coefficient of Variation 34
|
—
|
—
|
—
|
|
Renal Clearance (CLr) of Cis-CTB, Trans-CTBa, AVP, AVI and HPA: Part 2
HPA Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
1.390 Liter per hour
Geometric Coefficient of Variation 22
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 7Population: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
The lower limit of quantification for cis-CTB was 100.0 ng/mL, and for AVI and HPA was 10.0 ng/mL.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=5 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=3 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
Cis CTB Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
13660 Nanogram per milliliter
Geometric Coefficient of Variation 35
|
19540 Nanogram per milliliter
Geometric Coefficient of Variation 16
|
—
|
—
|
|
Maximum Observed Concentration (Cmax) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
Cis CTB Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
22080 Nanogram per milliliter
Geometric Coefficient of Variation 11
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Maximum Observed Concentration (Cmax) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
Cis CTB Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
21330 Nanogram per milliliter
Geometric Coefficient of Variation 14
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Maximum Observed Concentration (Cmax) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
AVI Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
5167 Nanogram per milliliter
Geometric Coefficient of Variation 49
|
6858 Nanogram per milliliter
Geometric Coefficient of Variation 24
|
—
|
—
|
|
Maximum Observed Concentration (Cmax) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
AVI Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
7677 Nanogram per milliliter
Geometric Coefficient of Variation 24
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Maximum Observed Concentration (Cmax) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
AVI Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
7279 Nanogram per milliliter
Geometric Coefficient of Variation 15
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Maximum Observed Concentration (Cmax) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
HPA Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
2248 Nanogram per milliliter
Geometric Coefficient of Variation 45
|
3341 Nanogram per milliliter
Geometric Coefficient of Variation 33
|
—
|
—
|
|
Maximum Observed Concentration (Cmax) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
HPA Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
3380 Nanogram per milliliter
Geometric Coefficient of Variation 14
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Maximum Observed Concentration (Cmax) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
HPA Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
3708 Nanogram per milliliter
Geometric Coefficient of Variation 8
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7Population: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
The lower limit of quantification for cis-CTB was 100.0 ng/mL, and for AVI and HPA was 10.0 ng/mL.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=5 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=3 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time for Cmax (Tmax) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
HPA Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
2.00 Hours
Interval 0.5 to 3.0
|
NA Hours
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Time for Cmax (Tmax) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
Cis CTB Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
4.03 Hours
Interval 4.03 to 6.03
|
3.05 Hours
Interval 2.57 to 4.05
|
—
|
—
|
|
Time for Cmax (Tmax) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
Cis CTB Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
3.03 Hours
Interval 2.53 to 4.03
|
NA Hours
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Time for Cmax (Tmax) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
Cis CTB Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
2.03 Hours
Interval 1.53 to 3.03
|
NA Hours
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Time for Cmax (Tmax) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
AVI Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
6.00 Hours
Interval 1.5 to 6.0
|
3.02 Hours
Interval 3.0 to 6.02
|
—
|
—
|
|
Time for Cmax (Tmax) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
AVI Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
4.00 Hours
Interval 2.5 to 6.02
|
NA Hours
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Time for Cmax (Tmax) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
AVI Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
1.50 Hours
Interval 1.0 to 2.5
|
NA Hours
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Time for Cmax (Tmax) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
HPA Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
6.00 Hours
Interval 1.0 to 6.0
|
4.00 Hours
Interval 2.5 to 6.02
|
—
|
—
|
|
Time for Cmax (Tmax) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
HPA Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
2.50 Hours
Interval 2.0 to 6.02
|
NA Hours
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 7Population: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Area under the plasma concentration time profile from time zero to time tau, the dosing interval, where tau is equal to 8 hours for TID dosing. The lower limit of quantification for cis-CTB was 100.0 ng/mL, and for AVI and HPA was 10.0 ng/mL.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=5 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=3 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Time Curve From Time Zero to Time Tau, the Dosing Interval (AUCtau) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
Cis CTB Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
52630 Nanogram*hours per milliliter
Geometric Coefficient of Variation 20
|
84790 Nanogram*hours per milliliter
Geometric Coefficient of Variation 17
|
—
|
—
|
|
Area Under the Plasma Concentration Time Curve From Time Zero to Time Tau, the Dosing Interval (AUCtau) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
Cis CTB Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
92920 Nanogram*hours per milliliter
Geometric Coefficient of Variation 9
|
NA Nanogram*hours per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Area Under the Plasma Concentration Time Curve From Time Zero to Time Tau, the Dosing Interval (AUCtau) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
Cis CTB Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
90270 Nanogram*hours per milliliter
Geometric Coefficient of Variation 9
|
NA Nanogram*hours per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Area Under the Plasma Concentration Time Curve From Time Zero to Time Tau, the Dosing Interval (AUCtau) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
AVI Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
22240 Nanogram*hours per milliliter
Geometric Coefficient of Variation 33
|
32650 Nanogram*hours per milliliter
Geometric Coefficient of Variation 32
|
—
|
—
|
|
Area Under the Plasma Concentration Time Curve From Time Zero to Time Tau, the Dosing Interval (AUCtau) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
AVI Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
38010 Nanogram*hours per milliliter
Geometric Coefficient of Variation 11
|
NA Nanogram*hours per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Area Under the Plasma Concentration Time Curve From Time Zero to Time Tau, the Dosing Interval (AUCtau) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
AVI Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
33100 Nanogram*hours per milliliter
Geometric Coefficient of Variation 8
|
NA Nanogram*hours per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Area Under the Plasma Concentration Time Curve From Time Zero to Time Tau, the Dosing Interval (AUCtau) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
HPA Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
10400 Nanogram*hours per milliliter
Geometric Coefficient of Variation 35
|
16670 Nanogram*hours per milliliter
Geometric Coefficient of Variation 35
|
—
|
—
|
|
Area Under the Plasma Concentration Time Curve From Time Zero to Time Tau, the Dosing Interval (AUCtau) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
HPA Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
19160 Nanogram*hours per milliliter
Geometric Coefficient of Variation 7
|
NA Nanogram*hours per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Area Under the Plasma Concentration Time Curve From Time Zero to Time Tau, the Dosing Interval (AUCtau) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
HPA Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
18890 Nanogram*hours per milliliter
Geometric Coefficient of Variation 11
|
NA Nanogram*hours per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7Population: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Dose-normalized Cmax was determined as Cmax/Dose. The lower limit of quantification for cis-CTB was 100.0 ng/mL, and for AVI and HPA was 10.0 ng/mL.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=5 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=3 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Dose-Normalized Cmax (Cmax[dn]) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
Cis CTB Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
34.16 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 35
|
48.90 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 16
|
—
|
—
|
|
Dose-Normalized Cmax (Cmax[dn]) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
Cis CTB Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
55.21 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 11
|
NA Nanogram per milliliter per milligram
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Dose-Normalized Cmax (Cmax[dn]) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
Cis CTB Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
53.35 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 14
|
NA Nanogram per milliliter per milligram
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Dose-Normalized Cmax (Cmax[dn]) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
AVI Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
5.714 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 49
|
7.582 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 24
|
—
|
—
|
|
Dose-Normalized Cmax (Cmax[dn]) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
AVI Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
8.483 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 24
|
NA Nanogram per milliliter per milligram
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Dose-Normalized Cmax (Cmax[dn]) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
AVI Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
8.046 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 15
|
NA Nanogram per milliliter per milligram
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Dose-Normalized Cmax (Cmax[dn]) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
HPA Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
5.549 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 45
|
8.249 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 33
|
—
|
—
|
|
Dose-Normalized Cmax (Cmax[dn]) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
HPA Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
8.339 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 14
|
NA Nanogram per milliliter per milligram
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Dose-Normalized Cmax (Cmax[dn]) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
HPA Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
9.145 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 8
|
NA Nanogram per milliliter per milligram
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 7Population: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Area under the plasma concentration time profile from time zero to time tau, the dosing interval, where tau is equal to 8 hours for TID dosing. The lower limit of quantification for cis-CTB was 100.0 ng/mL, and for AVI and HPA was 10.0 ng/mL.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=5 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=3 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Dose-Normalized AUCtau (AUCtau[dn]) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
Cis CTB Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
131.5 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 19
|
212.0 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 17
|
—
|
—
|
|
Dose-Normalized AUCtau (AUCtau[dn]) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
Cis CTB Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
232.3 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 9
|
NA Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Dose-Normalized AUCtau (AUCtau[dn]) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
Cis CTB Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
225.9 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 9
|
NA Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Dose-Normalized AUCtau (AUCtau[dn]) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
AVI Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
24.62 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 33
|
36.10 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 32
|
—
|
—
|
|
Dose-Normalized AUCtau (AUCtau[dn]) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
AVI Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
42.01 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 11
|
NA Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Dose-Normalized AUCtau (AUCtau[dn]) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
AVI Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
36.59 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 8
|
NA Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Dose-Normalized AUCtau (AUCtau[dn]) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
HPA Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
25.70 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 35
|
41.23 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 35
|
—
|
—
|
|
Dose-Normalized AUCtau (AUCtau[dn]) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
HPA Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
47.29 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 7
|
NA Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Dose-Normalized AUCtau (AUCtau[dn]) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
HPA Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
46.65 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 11
|
NA Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7Population: Pharmacokinetic analysis set. It was planned to report data for CTB 400 mg + AVP 1350 mg only. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
T1/2 was calculated as loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. The lower limit of quantification for cis-CTB was 100.0 ng/mL, and for AVI and HPA was 10.0 ng/mL.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=5 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=3 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Half-Life (t1/2) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
Cis CTB Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
2.788 Hours
Standard Deviation 0.80670
|
NA Hours
Standard Deviation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Terminal Half-Life (t1/2) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
AVI Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
5.734 Hours
Standard Deviation 2.6304
|
NA Hours
Standard Deviation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Terminal Half-Life (t1/2) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
HPA Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
5.290 Hours
Standard Deviation 1.7122
|
NA Hours
Standard Deviation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7Population: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Vz/F was calculated as Dose/(AUCinf \* kel) where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. The lower limit of quantification for cis-CTB was 100.0 ng/mL, and for AVI and HPA was 10.0 ng/mL.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=5 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=3 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
Cis CTB Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Liter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Apparent Volume of Distribution (Vz/F) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
Cis CTB Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
12.82 Liter
Geometric Coefficient of Variation 8
|
—
|
—
|
—
|
|
Apparent Volume of Distribution (Vz/F) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
Cis CTB Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
17.33 Liter
Geometric Coefficient of Variation 31
|
NA Liter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Apparent Volume of Distribution (Vz/F) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
AVI Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Liter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
NA Liter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Apparent Volume of Distribution (Vz/F) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
AVI Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
207.9 Liter
Geometric Coefficient of Variation 43
|
NA Liter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Apparent Volume of Distribution (Vz/F) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
HPA Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Liter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
NA Liter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Apparent Volume of Distribution (Vz/F) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
HPA Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
156.0 Liter
Geometric Coefficient of Variation 44
|
NA Liter
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7Population: Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
CL/F was calculated as Dose/AUCinf. The lower limit of quantification for cis-CTB was 100.0 ng/mL, and for AVI and HPA was 10.0 ng/mL.
Outcome measures
| Measure |
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=5 Participants
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=3 Participants
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
Cis CTB Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Liter/hour
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Apparent Clearance (CL/F) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
Cis CTB Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
4.303 Liter/hour
Geometric Coefficient of Variation 9
|
NA Liter/hour
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Apparent Clearance (CL/F) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
Cis CTB Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
4.428 Liter/hour
Geometric Coefficient of Variation 9
|
NA Liter/hour
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Apparent Clearance (CL/F) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
AVI Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
40.66 Liter/hour
Geometric Coefficient of Variation 33
|
27.69 Liter/hour
Geometric Coefficient of Variation 32
|
—
|
—
|
|
Apparent Clearance (CL/F) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
AVI Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
23.80 Liter/hour
Geometric Coefficient of Variation 11
|
NA Liter/hour
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Apparent Clearance (CL/F) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
AVI Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
27.33 Liter/hour
Geometric Coefficient of Variation 8
|
NA Liter/hour
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Apparent Clearance (CL/F) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
HPA Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
38.94 Liter/hour
Geometric Coefficient of Variation 35
|
24.26 Liter/hour
Geometric Coefficient of Variation 35
|
—
|
—
|
|
Apparent Clearance (CL/F) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
HPA Day 6
|
—
|
—
|
—
|
—
|
—
|
—
|
21.12 Liter/hour
Geometric Coefficient of Variation 7
|
NA Liter/hour
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
|
Apparent Clearance (CL/F) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
HPA Day 7
|
—
|
—
|
—
|
—
|
—
|
—
|
21.42 Liter/hour
Geometric Coefficient of Variation 11
|
NA Liter/hour
Geometric Coefficient of Variation NA
Data could not be calculated as values were below limit of quantification.
|
—
|
—
|
Adverse Events
CTB 400 mg + AVP 900 mg (Part-1)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo for CTB 400 mg + AVP 900 mg (Part-1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CTB 800 mg + AVP 1350 mg (Part-1)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo for CTB 800 mg + AVP 1350 mg (Part-1)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
CTB 800 mg (Part-1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo for CTB 800 mg (Part-1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CTB 1200 mg + AVP 1350 mg (Part-1)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo for CTB 1200 mg + AVP 1350 mg (Part-1)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
CTB 1600 mg (Part-1)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo for CTB 1600 mg (Part-1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CTB 400 mg + AVP 1350 mg q8h (Part-2)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo for CTB 400 mg + AVP 1350 mg q8h (Part-2)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
CTB 800 mg + AVP 1350 mg q8h (Part-2)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo for CTB 800 mg + AVP 1350 mg q8h (Part-2)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
CTB 400 mg + AVP 900 mg q8h (Part-2)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CTB 400 mg + AVP 900 mg (Part-1)
n=6 participants at risk
Healthy participants were administered a single oral dose of CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
|
Placebo for CTB 400 mg + AVP 900 mg (Part-1)
n=2 participants at risk
Healthy participants were administered a single oral dose of placebo for CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
|
CTB 800 mg + AVP 1350 mg (Part-1)
n=6 participants at risk
Healthy participants were administered a single oral dose of CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
Placebo for CTB 800 mg + AVP 1350 mg (Part-1)
n=2 participants at risk
Healthy participants were administered a single oral dose of placebo for CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
CTB 800 mg (Part-1)
n=6 participants at risk
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
|
Placebo for CTB 800 mg (Part-1)
n=2 participants at risk
Healthy participants were administered a single oral dose of placebo for CTB 800 mg in any of the treatment periods.
|
CTB 1200 mg + AVP 1350 mg (Part-1)
n=6 participants at risk
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
Placebo for CTB 1200 mg + AVP 1350 mg (Part-1)
n=2 participants at risk
Healthy participants were administered a single oral dose of placebo for CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
|
CTB 1600 mg (Part-1)
n=6 participants at risk
Healthy participants were administered a single oral dose of CTB 1600 mg in any of the treatment periods.
|
Placebo for CTB 1600 mg (Part-1)
n=2 participants at risk
Healthy participants were administered a single oral dose of placebo for CTB 1600 mg in any of the treatment periods.
|
CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=6 participants at risk
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Part-2)
n=2 participants at risk
Healthy participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 800 mg + AVP 1350 mg q8h (Part-2)
n=6 participants at risk
Healthy participants were administered CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 800 mg + AVP 1350 mg q8h (Part-2)
n=2 participants at risk
Healthy participants were administered placebo for CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 900 mg q8h (Part-2)
n=6 participants at risk
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
n=2 participants at risk
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
n=5 participants at risk
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
n=1 participants at risk
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=3 participants at risk
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
Placebo for CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
n=1 participants at risk
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
33.3%
1/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
33.3%
2/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
50.0%
1/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
50.0%
1/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Gastrointestinal disorders
Abdominal pain lower
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
33.3%
2/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
33.3%
2/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
50.0%
1/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
50.0%
1/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
33.3%
1/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
33.3%
2/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
33.3%
1/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
33.3%
2/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
50.0%
1/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
General disorders
Asthenia
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
General disorders
Axillary pain
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
General disorders
Fatigue
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
50.0%
1/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
General disorders
Feeling hot
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
50.0%
1/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
33.3%
2/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
33.3%
2/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
50.0%
1/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
50.0%
1/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
50.0%
1/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
33.3%
1/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
50.0%
1/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
33.3%
1/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
50.0%
1/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
33.3%
1/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
20.0%
1/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
50.0%
1/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
33.3%
2/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Nervous system disorders
Presyncope
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
33.3%
1/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
66.7%
2/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
50.0%
1/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
50.0%
1/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
20.0%
1/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
50.0%
1/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
20.0%
1/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
50.0%
1/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
33.3%
1/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
|
Vascular disorders
Haematoma
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
50.0%
1/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
16.7%
1/6 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/2 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/5 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
33.3%
1/3 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
0.00%
0/1 • From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER