Trial Outcomes & Findings for Drug-Drug Interaction Study of Vesatolimod in Adults With HIV-1 Who Have Very Low or Undetectable Virus Levels (NCT NCT05458102)
NCT ID: NCT05458102
Last Updated: 2024-12-03
Results Overview
AUClast is defined as an area under the concentration versus time curve from time zero to the last quantifiable concentration. Cohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6
Results posted on
2024-12-03
Participant Flow
Participants were enrolled at study sites in the United States.
59 participants were screened.
Participant milestones
| Measure |
Cohort 1: Vesatolimod + Cobicistat + Voriconazole
Participants received a single dose of vesatolimod (VES) 2 mg on Day 1 of Period 1. In Period 2, participants received cobicistat (COBI) 150 mg once daily on Days 1 to 5 along with a single dose of VES 2 mg on Day 2. In Period 3, participants received a loading dose of voriconazole (VOR) 400 mg twice daily on Day 1, then VOR 200 mg twice daily on Days 2 to 6, and a single dose of VES 2 mg in the morning on Day 3. There was a washout period of 7 to 14 days between treatments in Period 1 Day 1 and Period 2 Day 1 and a washout period of 14 to 21 days between treatments in Period 2 Day 5 and Period 3 Day 1.
|
Cohort 2: Vesatolimod + Rifabutin
Participants received a single dose of VES 6 mg on Day 1. In Period 2, participants received Rifabutin (RFB) 300 mg once daily on Days 1 to 9 along with a single dose of VES 6 mg on Day 6. There was a washout period of 7 to 14 days between treatments in Period 1 Day 1 and Period 2 Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
2
|
|
Overall Study
COMPLETED
|
11
|
2
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1: Vesatolimod + Cobicistat + Voriconazole
Participants received a single dose of vesatolimod (VES) 2 mg on Day 1 of Period 1. In Period 2, participants received cobicistat (COBI) 150 mg once daily on Days 1 to 5 along with a single dose of VES 2 mg on Day 2. In Period 3, participants received a loading dose of voriconazole (VOR) 400 mg twice daily on Day 1, then VOR 200 mg twice daily on Days 2 to 6, and a single dose of VES 2 mg in the morning on Day 3. There was a washout period of 7 to 14 days between treatments in Period 1 Day 1 and Period 2 Day 1 and a washout period of 14 to 21 days between treatments in Period 2 Day 5 and Period 3 Day 1.
|
Cohort 2: Vesatolimod + Rifabutin
Participants received a single dose of VES 6 mg on Day 1. In Period 2, participants received Rifabutin (RFB) 300 mg once daily on Days 1 to 9 along with a single dose of VES 6 mg on Day 6. There was a washout period of 7 to 14 days between treatments in Period 1 Day 1 and Period 2 Day 1.
|
|---|---|---|
|
Overall Study
Withdrew consent
|
2
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Enrolled but never treated
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
Baseline characteristics by cohort
| Measure |
Cohort 1: Vesatolimod + Cobicistat + Voriconazole
n=15 Participants
Participants received a single dose of vesatolimod (VES) 2 mg on Day 1 of Period 1. In Period 2, participants received cobicistat (COBI) 150 mg once daily on Days 1 to 5 along with a single dose of VES 2 mg on Day 2. In Period 3, participants received a loading dose of voriconazole (VOR) 400 mg twice daily on Day 1, then VOR 200 mg twice daily on Days 2 to 6, and a single dose of VES 2 mg in the morning on Day 3. There was a washout period of 7 to 14 days between treatments in Period 1 Day 1 and Period 2 Day 1 and a washout period of 14 to 21 days between treatments in Period 2 Day 5 and Period 3 Day 1.
|
Cohort 2: Vesatolimod + Rifabutin
n=2 Participants
Participants received a single dose of VES 6 mg on Day 1. In Period 2, participants received Rifabutin (RFB) 300 mg once daily on Days 1 to 9 along with a single dose of VES 6 mg on Day 6. There was a washout period of 7 to 14 days between treatments in Period 1 Day 1 and Period 2 Day 1.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=17 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=15 Participants
|
2 Participants
n=2 Participants
|
16 Participants
n=17 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=15 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=17 Participants
|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 14.5 • n=15 Participants
|
45 years
STANDARD_DEVIATION 14.8 • n=2 Participants
|
47 years
STANDARD_DEVIATION 14.0 • n=17 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=15 Participants • Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
0 Participants
Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
2 Participants
n=15 Participants • Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
|
Sex: Female, Male
Male
|
13 Participants
n=15 Participants • Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
0 Participants
Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
13 Participants
n=15 Participants • Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=15 Participants • Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
0 Participants
Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
3 Participants
n=15 Participants • Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=15 Participants • Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
0 Participants
Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
12 Participants
n=15 Participants • Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants • Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
0 Participants
Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
0 Participants
n=15 Participants • Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=15 Participants • Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
0 Participants
Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
1 Participants
n=15 Participants • Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=15 Participants • Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
0 Participants
Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
2 Participants
n=15 Participants • Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants • Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
0 Participants
Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
0 Participants
n=15 Participants • Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=15 Participants • Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
0 Participants
Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
10 Participants
n=15 Participants • Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
|
Race (NIH/OMB)
White
|
2 Participants
n=15 Participants • Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
0 Participants
Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
2 Participants
n=15 Participants • Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants • Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
0 Participants
Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
0 Participants
n=15 Participants • Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants • Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
0 Participants
Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
0 Participants
n=15 Participants • Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort.
|
|
Region of Enrollment
United States
|
15 Participants
n=15 Participants
|
2 Participants
n=2 Participants
|
17 Participants
n=17 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6Population: The VES PK Analysis Set included participants who received at least 1 dose of VES and had at least 1 nonmissing PK concentration value.
AUClast is defined as an area under the concentration versus time curve from time zero to the last quantifiable concentration. Cohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.
Outcome measures
| Measure |
Cohort 1: Vesatolimod 2 mg
n=15 Participants
Participants received a single dose of VES 2 mg on Day 1 of Period 1.
|
Cohort 1: Vesatolimod 2 mg + Cobicistat 150 mg
n=13 Participants
Participants received COBI 150 mg once daily on Days 1 to 5 along with a single dose of VES 2 mg on Day 2 in Period 2.
|
Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg
n=11 Participants
Participants received VOR 200 mg twice daily on Days 2 to 6, and a single dose of VES 2 mg in the morning on Day 3 in Period 3.
|
Cohort 2: Vesatolimod 6 mg
n=2 Participants
Participants received a single dose of VES 6 mg on Day 1 in Period 1.
|
Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg
n=2 Participants
Participants received RFB 300 mg once daily on Days 1 to 9 along with a single dose of VES 6 mg on Day 6 in Period 2.
|
Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg
Participants received VOR 200 mg twice along with a single dose of VES 2 mg on Day 3 in Period 3.
|
Cohort 2: Vesatolimod 6 mg
Participants received a single dose of VES 6 mg on Day 1 in Period 1.
|
Cohort 2: Rifabutin 300 mg
Participants received RFB 300 mg once daily on Days 1 to 9 in Period 2.
|
Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg
Participants received RFB 300 mg once along with a single dose of VES 6 mg on Day 6 in Period 2.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter : AUClast of Vesatolimod (VES)
|
13500 h*pg/mL
Standard Deviation 9500
|
61900 h*pg/mL
Standard Deviation 35400
|
14600 h*pg/mL
Standard Deviation 11000
|
16400 h*pg/mL
Standard Deviation 17900
|
86300 h*pg/mL
Standard Deviation 16000
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6Population: Participants in the VES PK Analysis Set with available data were analyzed. Data for Cohort 2 Vesatolimod 6mg are not reported due to participant's confidentiality reasons as there was only 1 participant in this cohort.
AUCinf is defined as an area under the concentration versus time curve extrapolated to infinite time, calculated as AUClast + (Clast/Lambda z). Cohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.
Outcome measures
| Measure |
Cohort 1: Vesatolimod 2 mg
n=13 Participants
Participants received a single dose of VES 2 mg on Day 1 of Period 1.
|
Cohort 1: Vesatolimod 2 mg + Cobicistat 150 mg
n=12 Participants
Participants received COBI 150 mg once daily on Days 1 to 5 along with a single dose of VES 2 mg on Day 2 in Period 2.
|
Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg
n=10 Participants
Participants received VOR 200 mg twice daily on Days 2 to 6, and a single dose of VES 2 mg in the morning on Day 3 in Period 3.
|
Cohort 2: Vesatolimod 6 mg
Participants received a single dose of VES 6 mg on Day 1 in Period 1.
|
Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg
n=2 Participants
Participants received RFB 300 mg once daily on Days 1 to 9 along with a single dose of VES 6 mg on Day 6 in Period 2.
|
Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg
Participants received VOR 200 mg twice along with a single dose of VES 2 mg on Day 3 in Period 3.
|
Cohort 2: Vesatolimod 6 mg
Participants received a single dose of VES 6 mg on Day 1 in Period 1.
|
Cohort 2: Rifabutin 300 mg
Participants received RFB 300 mg once daily on Days 1 to 9 in Period 2.
|
Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg
Participants received RFB 300 mg once along with a single dose of VES 6 mg on Day 6 in Period 2.
|
|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter : AUCinf of VES
|
17600 h*pg/mL
Standard Deviation 9220
|
68000 h*pg/mL
Standard Deviation 36600
|
17800 h*pg/mL
Standard Deviation 11600
|
—
|
88000 h*pg/mL
Standard Deviation 16800
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6Population: Participants in the VES PK Analysis Set were analyzed.
Cmax is defined as the maximum observed concentration of drug. Cohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.
Outcome measures
| Measure |
Cohort 1: Vesatolimod 2 mg
n=15 Participants
Participants received a single dose of VES 2 mg on Day 1 of Period 1.
|
Cohort 1: Vesatolimod 2 mg + Cobicistat 150 mg
n=13 Participants
Participants received COBI 150 mg once daily on Days 1 to 5 along with a single dose of VES 2 mg on Day 2 in Period 2.
|
Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg
n=11 Participants
Participants received VOR 200 mg twice daily on Days 2 to 6, and a single dose of VES 2 mg in the morning on Day 3 in Period 3.
|
Cohort 2: Vesatolimod 6 mg
n=2 Participants
Participants received a single dose of VES 6 mg on Day 1 in Period 1.
|
Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg
n=2 Participants
Participants received RFB 300 mg once daily on Days 1 to 9 along with a single dose of VES 6 mg on Day 6 in Period 2.
|
Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg
Participants received VOR 200 mg twice along with a single dose of VES 2 mg on Day 3 in Period 3.
|
Cohort 2: Vesatolimod 6 mg
Participants received a single dose of VES 6 mg on Day 1 in Period 1.
|
Cohort 2: Rifabutin 300 mg
Participants received RFB 300 mg once daily on Days 1 to 9 in Period 2.
|
Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg
Participants received RFB 300 mg once along with a single dose of VES 6 mg on Day 6 in Period 2.
|
|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter : Cmax of VES
|
1130 pg/mL
Standard Deviation 1020
|
6930 pg/mL
Standard Deviation 4650
|
1020 pg/mL
Standard Deviation 895
|
944 pg/mL
Standard Deviation 928
|
22200 pg/mL
Standard Deviation 7780
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6Population: Participants in the VES PK Analysis Set with available data were analyzed. Data for Cohort 2 Vesatolimod 6mg are not reported due to participant's confidentiality reasons as there was only 1 participant in this cohort.
%AUCexp is defined as the percentage of AUC extrapolated between AUClast and AUCinf, calculated as (\[AUCinf-AUClast\]/AUCinf)\*100. Cohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.
Outcome measures
| Measure |
Cohort 1: Vesatolimod 2 mg
n=13 Participants
Participants received a single dose of VES 2 mg on Day 1 of Period 1.
|
Cohort 1: Vesatolimod 2 mg + Cobicistat 150 mg
n=12 Participants
Participants received COBI 150 mg once daily on Days 1 to 5 along with a single dose of VES 2 mg on Day 2 in Period 2.
|
Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg
n=10 Participants
Participants received VOR 200 mg twice daily on Days 2 to 6, and a single dose of VES 2 mg in the morning on Day 3 in Period 3.
|
Cohort 2: Vesatolimod 6 mg
Participants received a single dose of VES 6 mg on Day 1 in Period 1.
|
Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg
n=2 Participants
Participants received RFB 300 mg once daily on Days 1 to 9 along with a single dose of VES 6 mg on Day 6 in Period 2.
|
Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg
Participants received VOR 200 mg twice along with a single dose of VES 2 mg on Day 3 in Period 3.
|
Cohort 2: Vesatolimod 6 mg
Participants received a single dose of VES 6 mg on Day 1 in Period 1.
|
Cohort 2: Rifabutin 300 mg
Participants received RFB 300 mg once daily on Days 1 to 9 in Period 2.
|
Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg
Participants received RFB 300 mg once along with a single dose of VES 6 mg on Day 6 in Period 2.
|
|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter : %AUCexp of VES
|
14.6 percentage of AUCexp
Standard Deviation 6.97
|
6.16 percentage of AUCexp
Standard Deviation 3.91
|
14.7 percentage of AUCexp
Standard Deviation 6.75
|
—
|
1.92 percentage of AUCexp
Standard Deviation 0.602
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6Population: Participants in the VES PK Analysis Set were analyzed.
Tmax is defined as the time (observed time point) of Cmax. Cohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.
Outcome measures
| Measure |
Cohort 1: Vesatolimod 2 mg
n=15 Participants
Participants received a single dose of VES 2 mg on Day 1 of Period 1.
|
Cohort 1: Vesatolimod 2 mg + Cobicistat 150 mg
n=13 Participants
Participants received COBI 150 mg once daily on Days 1 to 5 along with a single dose of VES 2 mg on Day 2 in Period 2.
|
Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg
n=11 Participants
Participants received VOR 200 mg twice daily on Days 2 to 6, and a single dose of VES 2 mg in the morning on Day 3 in Period 3.
|
Cohort 2: Vesatolimod 6 mg
n=2 Participants
Participants received a single dose of VES 6 mg on Day 1 in Period 1.
|
Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg
n=2 Participants
Participants received RFB 300 mg once daily on Days 1 to 9 along with a single dose of VES 6 mg on Day 6 in Period 2.
|
Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg
Participants received VOR 200 mg twice along with a single dose of VES 2 mg on Day 3 in Period 3.
|
Cohort 2: Vesatolimod 6 mg
Participants received a single dose of VES 6 mg on Day 1 in Period 1.
|
Cohort 2: Rifabutin 300 mg
Participants received RFB 300 mg once daily on Days 1 to 9 in Period 2.
|
Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg
Participants received RFB 300 mg once along with a single dose of VES 6 mg on Day 6 in Period 2.
|
|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter : Tmax of VES
|
3.03 hours
Interval 1.5 to 6.0
|
1.52 hours
Interval 1.5 to 2.48
|
2.50 hours
Interval 1.0 to 3.1
|
5.13 hours
Interval 4.18 to 6.07
|
1.28 hours
Interval 1.05 to 1.5
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6Population: Participants in the VES PK Analysis Set were analyzed.
Clast is defined as the last observed quantifiable concentration of the drug. Cohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.
Outcome measures
| Measure |
Cohort 1: Vesatolimod 2 mg
n=15 Participants
Participants received a single dose of VES 2 mg on Day 1 of Period 1.
|
Cohort 1: Vesatolimod 2 mg + Cobicistat 150 mg
n=13 Participants
Participants received COBI 150 mg once daily on Days 1 to 5 along with a single dose of VES 2 mg on Day 2 in Period 2.
|
Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg
n=11 Participants
Participants received VOR 200 mg twice daily on Days 2 to 6, and a single dose of VES 2 mg in the morning on Day 3 in Period 3.
|
Cohort 2: Vesatolimod 6 mg
n=2 Participants
Participants received a single dose of VES 6 mg on Day 1 in Period 1.
|
Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg
n=2 Participants
Participants received RFB 300 mg once daily on Days 1 to 9 along with a single dose of VES 6 mg on Day 6 in Period 2.
|
Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg
Participants received VOR 200 mg twice along with a single dose of VES 2 mg on Day 3 in Period 3.
|
Cohort 2: Vesatolimod 6 mg
Participants received a single dose of VES 6 mg on Day 1 in Period 1.
|
Cohort 2: Rifabutin 300 mg
Participants received RFB 300 mg once daily on Days 1 to 9 in Period 2.
|
Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg
Participants received RFB 300 mg once along with a single dose of VES 6 mg on Day 6 in Period 2.
|
|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter : Clast of VES
|
84.2 pg/mL
Standard Deviation 19.4
|
103 pg/mL
Standard Deviation 42.2
|
74.2 pg/mL
Standard Deviation 17.4
|
75.9 pg/mL
Standard Deviation 30.5
|
74.3 pg/mL
Standard Deviation 27.2
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6Population: Participants in the VES PK Analysis Set were analyzed.
Tlast is defined as the time (observed time point) of Clast. Cohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.
Outcome measures
| Measure |
Cohort 1: Vesatolimod 2 mg
n=15 Participants
Participants received a single dose of VES 2 mg on Day 1 of Period 1.
|
Cohort 1: Vesatolimod 2 mg + Cobicistat 150 mg
n=13 Participants
Participants received COBI 150 mg once daily on Days 1 to 5 along with a single dose of VES 2 mg on Day 2 in Period 2.
|
Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg
n=11 Participants
Participants received VOR 200 mg twice daily on Days 2 to 6, and a single dose of VES 2 mg in the morning on Day 3 in Period 3.
|
Cohort 2: Vesatolimod 6 mg
n=2 Participants
Participants received a single dose of VES 6 mg on Day 1 in Period 1.
|
Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg
n=2 Participants
Participants received RFB 300 mg once daily on Days 1 to 9 along with a single dose of VES 6 mg on Day 6 in Period 2.
|
Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg
Participants received VOR 200 mg twice along with a single dose of VES 2 mg on Day 3 in Period 3.
|
Cohort 2: Vesatolimod 6 mg
Participants received a single dose of VES 6 mg on Day 1 in Period 1.
|
Cohort 2: Rifabutin 300 mg
Participants received RFB 300 mg once daily on Days 1 to 9 in Period 2.
|
Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg
Participants received RFB 300 mg once along with a single dose of VES 6 mg on Day 6 in Period 2.
|
|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter : Tlast of VES
|
48.0 hours
Interval 24.1 to 72.0
|
72.0 hours
Interval 71.7 to 96.0
|
48.0 hours
Interval 24.3 to 96.0
|
59.8 hours
Interval 24.0 to 95.5
|
72.0 hours
Interval 72.0 to 72.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6Population: Participants in the VES PK Analysis Set with available data were analyzed. Data for Cohort 2 Vesatolimod 6mg are not reported due to participant's confidentiality reasons as there was only 1 participant in this cohort.
Lambda z is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log concentration of drug versus time curve of the drug. Cohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.
Outcome measures
| Measure |
Cohort 1: Vesatolimod 2 mg
n=14 Participants
Participants received a single dose of VES 2 mg on Day 1 of Period 1.
|
Cohort 1: Vesatolimod 2 mg + Cobicistat 150 mg
n=12 Participants
Participants received COBI 150 mg once daily on Days 1 to 5 along with a single dose of VES 2 mg on Day 2 in Period 2.
|
Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg
n=11 Participants
Participants received VOR 200 mg twice daily on Days 2 to 6, and a single dose of VES 2 mg in the morning on Day 3 in Period 3.
|
Cohort 2: Vesatolimod 6 mg
Participants received a single dose of VES 6 mg on Day 1 in Period 1.
|
Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg
n=2 Participants
Participants received RFB 300 mg once daily on Days 1 to 9 along with a single dose of VES 6 mg on Day 6 in Period 2.
|
Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg
Participants received VOR 200 mg twice along with a single dose of VES 2 mg on Day 3 in Period 3.
|
Cohort 2: Vesatolimod 6 mg
Participants received a single dose of VES 6 mg on Day 1 in Period 1.
|
Cohort 2: Rifabutin 300 mg
Participants received RFB 300 mg once daily on Days 1 to 9 in Period 2.
|
Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg
Participants received RFB 300 mg once along with a single dose of VES 6 mg on Day 6 in Period 2.
|
|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter : Lambda z of VES
|
0.0381 per hour
Interval 0.031 to 0.0528
|
0.0310 per hour
Interval 0.0252 to 0.0425
|
0.0321 per hour
Interval 0.0241 to 0.0561
|
—
|
0.0442 per hour
Interval 0.04 to 0.0485
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6Population: Participants in the VES PK Analysis Set with available data were analyzed. Data for Cohort 2 Vesatolimod 6mg are not reported due to participant's confidentiality reasons as there was only 1 participant in this cohort.
t1/2 is defined as the terminal elimination half-life. Cohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.
Outcome measures
| Measure |
Cohort 1: Vesatolimod 2 mg
n=14 Participants
Participants received a single dose of VES 2 mg on Day 1 of Period 1.
|
Cohort 1: Vesatolimod 2 mg + Cobicistat 150 mg
n=12 Participants
Participants received COBI 150 mg once daily on Days 1 to 5 along with a single dose of VES 2 mg on Day 2 in Period 2.
|
Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg
n=11 Participants
Participants received VOR 200 mg twice daily on Days 2 to 6, and a single dose of VES 2 mg in the morning on Day 3 in Period 3.
|
Cohort 2: Vesatolimod 6 mg
Participants received a single dose of VES 6 mg on Day 1 in Period 1.
|
Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg
n=2 Participants
Participants received RFB 300 mg once daily on Days 1 to 9 along with a single dose of VES 6 mg on Day 6 in Period 2.
|
Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg
Participants received VOR 200 mg twice along with a single dose of VES 2 mg on Day 3 in Period 3.
|
Cohort 2: Vesatolimod 6 mg
Participants received a single dose of VES 6 mg on Day 1 in Period 1.
|
Cohort 2: Rifabutin 300 mg
Participants received RFB 300 mg once daily on Days 1 to 9 in Period 2.
|
Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg
Participants received RFB 300 mg once along with a single dose of VES 6 mg on Day 6 in Period 2.
|
|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter : t1/2 of VES
|
18.4 hours
Interval 13.1 to 22.3
|
22.4 hours
Interval 16.7 to 27.6
|
21.6 hours
Interval 12.4 to 28.7
|
—
|
15.8 hours
Interval 14.3 to 17.4
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6Population: Participants in the VES PK Analysis Set with available data were analyzed. Data for Cohort 2 Vesatolimod 6mg are not reported due to participant's confidentiality reasons as there was only 1 participant in this cohort.
CL/F is defined as an apparent oral clearance. Cohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.
Outcome measures
| Measure |
Cohort 1: Vesatolimod 2 mg
n=13 Participants
Participants received a single dose of VES 2 mg on Day 1 of Period 1.
|
Cohort 1: Vesatolimod 2 mg + Cobicistat 150 mg
n=12 Participants
Participants received COBI 150 mg once daily on Days 1 to 5 along with a single dose of VES 2 mg on Day 2 in Period 2.
|
Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg
n=10 Participants
Participants received VOR 200 mg twice daily on Days 2 to 6, and a single dose of VES 2 mg in the morning on Day 3 in Period 3.
|
Cohort 2: Vesatolimod 6 mg
Participants received a single dose of VES 6 mg on Day 1 in Period 1.
|
Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg
n=2 Participants
Participants received RFB 300 mg once daily on Days 1 to 9 along with a single dose of VES 6 mg on Day 6 in Period 2.
|
Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg
Participants received VOR 200 mg twice along with a single dose of VES 2 mg on Day 3 in Period 3.
|
Cohort 2: Vesatolimod 6 mg
Participants received a single dose of VES 6 mg on Day 1 in Period 1.
|
Cohort 2: Rifabutin 300 mg
Participants received RFB 300 mg once daily on Days 1 to 9 in Period 2.
|
Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg
Participants received RFB 300 mg once along with a single dose of VES 6 mg on Day 6 in Period 2.
|
|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter : CL/F of VES
|
156 L/h
Standard Deviation 92.9
|
42.4 L/h
Standard Deviation 28.5
|
176 L/h
Standard Deviation 137
|
—
|
69.4 L/h
Standard Deviation 13.3
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6Population: Participants in the VES PK Analysis Set with available data were analyzed. Data for Cohort 2 Vesatolimod 6mg are not reported due to participant's confidentiality reasons as there was only 1 participant in this cohort.
Vz/F is defined as an apparent volume of distribution of the drug. Cohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.
Outcome measures
| Measure |
Cohort 1: Vesatolimod 2 mg
n=13 Participants
Participants received a single dose of VES 2 mg on Day 1 of Period 1.
|
Cohort 1: Vesatolimod 2 mg + Cobicistat 150 mg
n=12 Participants
Participants received COBI 150 mg once daily on Days 1 to 5 along with a single dose of VES 2 mg on Day 2 in Period 2.
|
Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg
n=10 Participants
Participants received VOR 200 mg twice daily on Days 2 to 6, and a single dose of VES 2 mg in the morning on Day 3 in Period 3.
|
Cohort 2: Vesatolimod 6 mg
Participants received a single dose of VES 6 mg on Day 1 in Period 1.
|
Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg
n=2 Participants
Participants received RFB 300 mg once daily on Days 1 to 9 along with a single dose of VES 6 mg on Day 6 in Period 2.
|
Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg
Participants received VOR 200 mg twice along with a single dose of VES 2 mg on Day 3 in Period 3.
|
Cohort 2: Vesatolimod 6 mg
Participants received a single dose of VES 6 mg on Day 1 in Period 1.
|
Cohort 2: Rifabutin 300 mg
Participants received RFB 300 mg once daily on Days 1 to 9 in Period 2.
|
Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg
Participants received RFB 300 mg once along with a single dose of VES 6 mg on Day 6 in Period 2.
|
|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter : Vz/F of VES
|
3480 L
Standard Deviation 1530
|
1320 L
Standard Deviation 1100
|
4330 L
Standard Deviation 2220
|
—
|
1560 L
Standard Deviation 86.7
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: First dose date up to last dose date plus 30 days (up to 77 days for Cohort 1, and up to 54 days for Cohort 2)Population: Participants in Safety Analysis Set were analyzed. Per planned analysis, the data for adverse events were summarized by study treatments administered in Cohorts 1 and 2 per period.
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can, therefore, be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. Adverse events may also include pretreatment or posttreatment complications that occur as a result of protocol-specified procedures, or special situations. TEAES included all AEs began on or after the study drug start date.
Outcome measures
| Measure |
Cohort 1: Vesatolimod 2 mg
n=15 Participants
Participants received a single dose of VES 2 mg on Day 1 of Period 1.
|
Cohort 1: Vesatolimod 2 mg + Cobicistat 150 mg
n=13 Participants
Participants received COBI 150 mg once daily on Days 1 to 5 along with a single dose of VES 2 mg on Day 2 in Period 2.
|
Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg
n=13 Participants
Participants received VOR 200 mg twice daily on Days 2 to 6, and a single dose of VES 2 mg in the morning on Day 3 in Period 3.
|
Cohort 2: Vesatolimod 6 mg
n=11 Participants
Participants received a single dose of VES 6 mg on Day 1 in Period 1.
|
Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg
n=11 Participants
Participants received RFB 300 mg once daily on Days 1 to 9 along with a single dose of VES 6 mg on Day 6 in Period 2.
|
Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg
n=11 Participants
Participants received VOR 200 mg twice along with a single dose of VES 2 mg on Day 3 in Period 3.
|
Cohort 2: Vesatolimod 6 mg
n=2 Participants
Participants received a single dose of VES 6 mg on Day 1 in Period 1.
|
Cohort 2: Rifabutin 300 mg
n=2 Participants
Participants received RFB 300 mg once daily on Days 1 to 9 in Period 2.
|
Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg
n=2 Participants
Participants received RFB 300 mg once along with a single dose of VES 6 mg on Day 6 in Period 2.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
|
13.3 percentage of participants
|
38.5 percentage of participants
|
0 percentage of participants
|
36.4 percentage of participants
|
9.1 percentage of participants
|
9.1 percentage of participants
|
0 percentage of participants
|
50.0 percentage of participants
|
50.0 percentage of participants
|
PRIMARY outcome
Timeframe: First dose date up to last dose date plus 30 days (up to 77 days for Cohort 1, and up to 54 days for Cohort 2)Population: Participants in Safety Analysis Set with available data were analyzed. Per planned analysis, the data for adverse events were summarized by study treatments administered in Cohorts 1 and 2 per period.
A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from predose at any time postdose. Data for participants with post baseline toxicity grade 1 or higher is reported.
Outcome measures
| Measure |
Cohort 1: Vesatolimod 2 mg
n=14 Participants
Participants received a single dose of VES 2 mg on Day 1 of Period 1.
|
Cohort 1: Vesatolimod 2 mg + Cobicistat 150 mg
n=13 Participants
Participants received COBI 150 mg once daily on Days 1 to 5 along with a single dose of VES 2 mg on Day 2 in Period 2.
|
Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg
Participants received VOR 200 mg twice daily on Days 2 to 6, and a single dose of VES 2 mg in the morning on Day 3 in Period 3.
|
Cohort 2: Vesatolimod 6 mg
Participants received a single dose of VES 6 mg on Day 1 in Period 1.
|
Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg
n=11 Participants
Participants received RFB 300 mg once daily on Days 1 to 9 along with a single dose of VES 6 mg on Day 6 in Period 2.
|
Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg
Participants received VOR 200 mg twice along with a single dose of VES 2 mg on Day 3 in Period 3.
|
Cohort 2: Vesatolimod 6 mg
n=2 Participants
Participants received a single dose of VES 6 mg on Day 1 in Period 1.
|
Cohort 2: Rifabutin 300 mg
n=2 Participants
Participants received RFB 300 mg once daily on Days 1 to 9 in Period 2.
|
Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg
Participants received RFB 300 mg once along with a single dose of VES 6 mg on Day 6 in Period 2.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities
|
35.7 percentage of participants
|
53.8 percentage of participants
|
—
|
—
|
63.6 percentage of participants
|
—
|
50.0 percentage of participants
|
100.0 percentage of participants
|
—
|
Adverse Events
Cohort 1: Vesatolimod 2 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 1: Cobicistat 150 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 1: Vesatolimod 2 mg + Cobicistat 150 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 1: Voriconazole 400 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 1: Voriconazole 200 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 1: No Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2: Vesatolimod 6 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2: Rifabutin 300 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: Vesatolimod 2 mg
n=15 participants at risk
Participants received a single dose of VES 2 mg on Day 1 of Period 1.
|
Cohort 1: Cobicistat 150 mg
n=13 participants at risk
Participants received COBI 150 mg once daily on Days 1 to 5 in Period 2.
|
Cohort 1: Vesatolimod 2 mg + Cobicistat 150 mg
n=13 participants at risk
Participants received COBI 150 mg once along with a single dose of VES 2 mg on Day 2 in Period 2.
|
Cohort 1: Voriconazole 400 mg
n=11 participants at risk
Participants received a loading dose of VOR 400 mg twice daily on Day 1 in Period 3.
|
Cohort 1: Voriconazole 200 mg
n=11 participants at risk
Participants received VOR 200 mg twice daily on Days 2 to 6 in Period 3.
|
Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg
n=11 participants at risk
Participants received VOR 200 mg twice along with a single dose of VES 2 mg on Day 3 in Period 3.
|
Cohort 1: No Treatment
Participant was enrolled but was not dosed.
|
Cohort 2: Vesatolimod 6 mg
n=2 participants at risk
Participants received a single dose of VES 6 mg on Day 1 in Period 1.
|
Cohort 2: Rifabutin 300 mg
n=2 participants at risk
Participants received RFB 300 mg once daily on Days 1 to 9 in Period 2.
|
Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg
n=2 participants at risk
Participants received RFB 300 mg once along with a single dose of VES 6 mg on Day 6 in Period 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Photophobia
|
0.00%
0/15 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
9.1%
1/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
9.1%
1/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
—
0/0 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
|
Eye disorders
Photopsia
|
0.00%
0/15 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
18.2%
2/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
—
0/0 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
|
Eye disorders
Vision blurred
|
0.00%
0/15 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
7.7%
1/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
—
0/0 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
|
Eye disorders
Visual impairment
|
0.00%
0/15 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
9.1%
1/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
9.1%
1/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
9.1%
1/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
—
0/0 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
7.7%
1/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
—
0/0 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/15 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
7.7%
1/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
—
0/0 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
|
Infections and infestations
Covid-19
|
0.00%
0/15 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
7.7%
1/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
—
0/0 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/15 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
7.7%
1/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
—
0/0 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
50.0%
1/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
18.2%
2/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
9.1%
1/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
—
0/0 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
7.7%
1/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
—
0/0 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/15 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
9.1%
1/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
9.1%
1/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
—
0/0 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
|
Renal and urinary disorders
Proteinuria
|
6.7%
1/15 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
—
0/0 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/15 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
—
0/0 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
50.0%
1/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
|
General disorders
Chills
|
0.00%
0/15 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
—
0/0 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
50.0%
1/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
|
General disorders
Fatigue
|
0.00%
0/15 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
—
0/0 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
50.0%
1/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
|
General disorders
Pyrexia
|
0.00%
0/15 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
—
0/0 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
50.0%
1/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
—
0/0 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
50.0%
1/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
|
Vascular disorders
Hypertension
|
0.00%
0/15 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
—
0/0 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
50.0%
1/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/15 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
—
0/0 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
50.0%
1/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/15 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/13 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/11 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
—
0/0 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
0.00%
0/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
50.0%
1/2 • Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated. Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER