Trial Outcomes & Findings for Study to Evaluate a HIV Drug for the Treatment of HIV Infection (NCT NCT01803074)
NCT ID: NCT01803074
Last Updated: 2019-11-25
Results Overview
Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Change in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 monotherapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
107 participants
Primary outcome timeframe
Baseline (Day 1) and Day 11 after the final dose with BMS-955176
Results posted on
2019-11-25
Participant Flow
The study was conducted at 3 centers in 3 countries (1 in Germany, 1 in the United Kingdom, 1 in South Africa) from 04-April-2013 to 29-November-2014.
Participants screened were 191 of which 84 were screen failures (Participant withdrew consent: 3, Pregnancy: 3, Participant no longer meets study criteria: 73, Not according to participant's schedule: 1, Not included since cohort was closed: 3 and back up participant: 1). Only 107 participants (Part A: 60; Part B: 28; and Part C: 19) were enrolled.
Participant milestones
| Measure |
Part A-Group 10: BMS-955176 (120 mg)
Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade B
Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir
Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part C-Group 8: BMS-955176 (40 mg)
Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part C-Group 13: BMS-955176 (120 mg)
Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade C
Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 1: BMS-955176 (5 mg)
Participants infected with Human Immunodeficiency Virus Type-1 (HIV-1) clade B were treated with 5 milligrams (mg) BMS-955176 as oral suspension, once daily (QD) from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 2: BMS-955176 (10 mg)
Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 3: BMS-955176 (20 mg)
Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 4: BMS-955176 (40 mg)
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 9: BMS-955176 (80 mg)
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Period 1: Part A (HIV-1 Clade B)
STARTED
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8
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12
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0
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0
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0
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0
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0
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0
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0
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8
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8
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8
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8
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8
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Period 1: Part A (HIV-1 Clade B)
COMPLETED
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8
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12
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0
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0
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0
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0
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0
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0
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0
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8
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8
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8
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8
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8
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Period 1: Part A (HIV-1 Clade B)
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Period 2: Part B (HIV-1 Clade B)
STARTED
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0
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0
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8
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8
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4
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8
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0
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0
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0
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0
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0
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0
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0
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0
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Period 2: Part B (HIV-1 Clade B)
COMPLETED
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0
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0
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8
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8
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4
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8
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0
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0
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0
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0
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0
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0
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0
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0
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Period 2: Part B (HIV-1 Clade B)
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Period 3: Part C (HIV-1 Clade C Only)
STARTED
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0
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0
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0
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0
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0
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0
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8
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7
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4
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0
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0
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0
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0
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0
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Period 3: Part C (HIV-1 Clade C Only)
COMPLETED
|
0
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0
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0
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0
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0
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0
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8
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7
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4
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0
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0
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0
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0
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0
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Period 3: Part C (HIV-1 Clade C Only)
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate a HIV Drug for the Treatment of HIV Infection
Baseline characteristics by cohort
| Measure |
Part A-Group 1: BMS-955176 (5 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 2: BMS-955176 (10 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 3: BMS-955176 (20 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 4: BMS-955176 (40 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 9: BMS-955176 (80 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 10: BMS-955176 (120 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade B
n=12 Participants
Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
n=4 Participants
Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part C-Group 8: BMS-955176 (40 mg)
n=8 Participants
Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part C-Group 13: BMS-955176 (120 mg)
n=7 Participants
Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade C
n=4 Participants
Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
41.6 Years
STANDARD_DEVIATION 8.73 • n=5 Participants
|
37.5 Years
STANDARD_DEVIATION 11.07 • n=7 Participants
|
33.3 Years
STANDARD_DEVIATION 7.19 • n=5 Participants
|
39.5 Years
STANDARD_DEVIATION 8.09 • n=4 Participants
|
36.3 Years
STANDARD_DEVIATION 11.23 • n=21 Participants
|
38.0 Years
STANDARD_DEVIATION 9.49 • n=8 Participants
|
36.3 Years
STANDARD_DEVIATION 7.12 • n=8 Participants
|
33.0 Years
STANDARD_DEVIATION 7.21 • n=24 Participants
|
36.3 Years
STANDARD_DEVIATION 9.24 • n=42 Participants
|
32.8 Years
STANDARD_DEVIATION 10.21 • n=42 Participants
|
34.3 Years
STANDARD_DEVIATION 6.80 • n=42 Participants
|
33.6 Years
STANDARD_DEVIATION 7.80 • n=42 Participants
|
35.4 Years
STANDARD_DEVIATION 9.59 • n=36 Participants
|
35.3 Years
STANDARD_DEVIATION 8.54 • n=36 Participants
|
36.1 Years
STANDARD_DEVIATION 8.54 • n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
8 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
5 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
99 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
84 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
7 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
17 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
5 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Day 11 after the final dose with BMS-955176Population: All Treated Subjects Population comprised of all participants who had received at least one dose of study drug.
Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Change in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 monotherapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values.
Outcome measures
| Measure |
Part A-Group 1: BMS-955176 (5 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 2: BMS-955176 (10 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 3: BMS-955176 (20 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 4: BMS-955176 (40 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 9: BMS-955176 (80 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 10: BMS-955176 (120 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
n=4 Participants
Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part C-Group 8: BMS-955176 (40 mg)
n=8 Participants
Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part C-Group 13: BMS-955176 (120 mg)
n=7 Participants
Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade B
n=12 Participants
Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade C
n=4 Participants
Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11
|
-0.138 Log10 copies per milliliter (c/mL)
Standard Deviation 0.1281
|
-0.567 Log10 copies per milliliter (c/mL)
Standard Deviation 0.5845
|
-0.889 Log10 copies per milliliter (c/mL)
Standard Deviation 0.6582
|
-1.279 Log10 copies per milliliter (c/mL)
Standard Deviation 0.4596
|
-1.339 Log10 copies per milliliter (c/mL)
Standard Deviation 0.29
|
-1.326 Log10 copies per milliliter (c/mL)
Standard Deviation 0.3855
|
-1.216 Log10 copies per milliliter (c/mL)
Standard Deviation 0.4366
|
-1.431 Log10 copies per milliliter (c/mL)
Standard Deviation 0.2967
|
-1.544 Log10 copies per milliliter (c/mL)
Standard Deviation 0.4155
|
-1.521 Log10 copies per milliliter (c/mL)
Standard Deviation 0.2651
|
-1.29 Log10 copies per milliliter (c/mL)
Standard Deviation 0.3376
|
-0.938 Log10 copies per milliliter (c/mL)
Standard Deviation 0.6897
|
0.118 Log10 copies per milliliter (c/mL)
Standard Deviation 0.5277
|
-0.172 Log10 copies per milliliter (c/mL)
Standard Deviation 0.7876
|
SECONDARY outcome
Timeframe: Pre-dose Day 1 and Day 10Population: Pharmacokinetic Population comprised of all participants who received any study medication and had any available concentration-time data.
Time to reach the maximum plasma concentration was directly determined from concentration time data.
Outcome measures
| Measure |
Part A-Group 1: BMS-955176 (5 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 2: BMS-955176 (10 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 3: BMS-955176 (20 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 4: BMS-955176 (40 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 9: BMS-955176 (80 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 10: BMS-955176 (120 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir
n=7 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part C-Group 8: BMS-955176 (40 mg)
Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part C-Group 13: BMS-955176 (120 mg)
Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade B
Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade C
Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C
Day 1
|
3 Hours
Interval 1.5 to 6.0
|
2.51 Hours
Interval 2.0 to 4.0
|
3 Hours
Interval 3.0 to 6.0
|
4 Hours
Interval 2.0 to 6.0
|
3.5 Hours
Interval 3.0 to 4.0
|
3 Hours
Interval 1.5 to 6.0
|
3.5 Hours
Interval 2.0 to 10.0
|
3.53 Hours
Interval 2.0 to 4.25
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C
Day 10
|
3 Hours
Interval 2.0 to 4.0
|
3 Hours
Interval 1.5 to 4.0
|
4 Hours
Interval 3.0 to 16.0
|
3 Hours
Interval 2.0 to 6.0
|
3 Hours
Interval 1.5 to 4.02
|
2.5 Hours
Interval 1.5 to 3.87
|
3 Hours
Interval 2.0 to 6.0
|
3 Hours
Interval 1.55 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to end of the study (Day 42)Population: All Treated Subjects Population.
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug.
Outcome measures
| Measure |
Part A-Group 1: BMS-955176 (5 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 2: BMS-955176 (10 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 3: BMS-955176 (20 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 4: BMS-955176 (40 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 9: BMS-955176 (80 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 10: BMS-955176 (120 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
n=4 Participants
Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part C-Group 8: BMS-955176 (40 mg)
n=8 Participants
Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part C-Group 13: BMS-955176 (120 mg)
n=7 Participants
Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade B
n=12 Participants
Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade C
n=4 Participants
Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), and Discontinuations Due to AEs During the Study
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), and Discontinuations Due to AEs During the Study
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), and Discontinuations Due to AEs During the Study
Related SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), and Discontinuations Due to AEs During the Study
Discontinuations due to SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), and Discontinuations Due to AEs During the Study
Discontinuations due to AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), and Discontinuations Due to AEs During the Study
AEs
|
5 Participants
|
5 Participants
|
5 Participants
|
6 Participants
|
8 Participants
|
7 Participants
|
8 Participants
|
8 Participants
|
4 Participants
|
6 Participants
|
7 Participants
|
6 Participants
|
9 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 24Population: All Treated Subjects Population.
Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Maximum decline from Baseline in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values.
Outcome measures
| Measure |
Part A-Group 1: BMS-955176 (5 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 2: BMS-955176 (10 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 3: BMS-955176 (20 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 4: BMS-955176 (40 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 9: BMS-955176 (80 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 10: BMS-955176 (120 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir
n=7 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
n=12 Participants
Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
n=4 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part C-Group 8: BMS-955176 (40 mg)
Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part C-Group 13: BMS-955176 (120 mg)
Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade B
Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade C
Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Decline From Baseline in Log10 HIV-1 RNA - Part A and C
|
-0.498 Log10 copies/mL
Interval -0.78 to -0.22
|
-0.976 Log10 copies/mL
Interval -1.76 to -0.64
|
-1.115 Log10 copies/mL
Interval -2.12 to -0.13
|
-1.701 Log10 copies/mL
Interval -1.88 to -0.93
|
-1.555 Log10 copies/mL
Interval -1.82 to -1.04
|
-1.654 Log10 copies/mL
Interval -2.07 to -0.83
|
-1.352 Log10 copies/mL
Interval -2.03 to -1.04
|
-1.257 Log10 copies/mL
Interval -2.02 to -0.7
|
-0.381 Log10 copies/mL
Interval -1.46 to 0.56
|
-0.419 Log10 copies/mL
Interval -1.21 to 0.22
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 42Population: All Treated Subjects Population.
Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Maximum decline from Baseline in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values.
Outcome measures
| Measure |
Part A-Group 1: BMS-955176 (5 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 2: BMS-955176 (10 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 3: BMS-955176 (20 mg)
n=4 Participants
Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 4: BMS-955176 (40 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 9: BMS-955176 (80 mg)
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 10: BMS-955176 (120 mg)
Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir
Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part C-Group 8: BMS-955176 (40 mg)
Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part C-Group 13: BMS-955176 (120 mg)
Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade B
Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade C
Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Decline From Baseline in Log10 HIV-1 RNA - Part B
|
-1.858 Log10 copies/mL
Interval -2.37 to -1.49
|
-2.202 Log10 copies/mL
Interval -3.52 to -1.24
|
-2.39 Log10 copies/mL
Interval -3.04 to -1.83
|
-2.228 Log10 copies/mL
Interval -2.68 to -1.87
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 24Population: All Treated Subjects Population.
Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Time to maximum decline in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values.
Outcome measures
| Measure |
Part A-Group 1: BMS-955176 (5 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 2: BMS-955176 (10 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 3: BMS-955176 (20 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 4: BMS-955176 (40 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 9: BMS-955176 (80 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 10: BMS-955176 (120 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir
n=7 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
n=12 Participants
Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
n=4 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part C-Group 8: BMS-955176 (40 mg)
Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part C-Group 13: BMS-955176 (120 mg)
Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade B
Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade C
Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Decline in Log 10 HIV-1 RNA - Part A and C
|
168 Hours
Interval 72.0 to 433.4
|
216 Hours
Interval 48.0 to 553.5
|
203.9 Hours
Interval 168.0 to 288.1
|
240.15 Hours
Interval 120.1 to 312.1
|
204 Hours
Interval 168.0 to 384.6
|
240.2 Hours
Interval 216.0 to 288.3
|
228.05 Hours
Interval 192.0 to 384.6
|
215.8 Hours
Interval 120.0 to 312.0
|
216.2 Hours
Interval 24.0 to 433.8
|
132.05 Hours
Interval 23.9 to 786.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 42Population: All Treated Subjects Population.
Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Time to maximum decline in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values.
Outcome measures
| Measure |
Part A-Group 1: BMS-955176 (5 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 2: BMS-955176 (10 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 3: BMS-955176 (20 mg)
n=4 Participants
Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 4: BMS-955176 (40 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 9: BMS-955176 (80 mg)
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 10: BMS-955176 (120 mg)
Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir
Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part C-Group 8: BMS-955176 (40 mg)
Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part C-Group 13: BMS-955176 (120 mg)
Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade B
Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade C
Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Decline in Log 10 HIV-1 RNA - Part B
|
624 Hours
Interval 360.0 to 816.0
|
636.05 Hours
Interval 216.0 to 816.9
|
588 Hours
Interval 528.0 to 672.1
|
636.05 Hours
Interval 528.0 to 816.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 24Population: All Treated Subjects Population. Only those participants with data available at the specified time points were analyzed.
Change in the CD4+ and CD8+ cell counts from Baseline were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values.
Outcome measures
| Measure |
Part A-Group 1: BMS-955176 (5 mg)
n=6 Participants
Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 2: BMS-955176 (10 mg)
n=7 Participants
Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 3: BMS-955176 (20 mg)
n=7 Participants
Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 4: BMS-955176 (40 mg)
n=7 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 9: BMS-955176 (80 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 10: BMS-955176 (120 mg)
n=7 Participants
Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir
n=6 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir
n=6 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
n=9 Participants
Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
n=4 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part C-Group 8: BMS-955176 (40 mg)
Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part C-Group 13: BMS-955176 (120 mg)
Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade B
Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade C
Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C
CD4+
|
-21.8 Cells/microliter
Standard Deviation 88.37
|
14.6 Cells/microliter
Standard Deviation 120.82
|
-70.1 Cells/microliter
Standard Deviation 68.49
|
-23.6 Cells/microliter
Standard Deviation 42.13
|
-43.8 Cells/microliter
Standard Deviation 69.5
|
-56.7 Cells/microliter
Standard Deviation 78.26
|
-53.7 Cells/microliter
Standard Deviation 93.76
|
24.5 Cells/microliter
Standard Deviation 57.58
|
-77.3 Cells/microliter
Standard Deviation 91.05
|
18 Cells/microliter
Standard Deviation 67.3
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C
CD8+
|
-95 Cells/microliter
Standard Deviation 301.52
|
-8.3 Cells/microliter
Standard Deviation 236.48
|
-107.4 Cells/microliter
Standard Deviation 264.26
|
-57.3 Cells/microliter
Standard Deviation 126.25
|
-194.6 Cells/microliter
Standard Deviation 182.3
|
-161.3 Cells/microliter
Standard Deviation 203.01
|
-214.4 Cells/microliter
Standard Deviation 390.13
|
-155.8 Cells/microliter
Standard Deviation 56.55
|
-93.1 Cells/microliter
Standard Deviation 138.52
|
-136.3 Cells/microliter
Standard Deviation 224.49
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 42Population: All Treated Subjects Population. Only those participants with data available at the specified time points were analyzed.
Change in the CD4+ and CD8+ cell counts from Baseline were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values.
Outcome measures
| Measure |
Part A-Group 1: BMS-955176 (5 mg)
n=5 Participants
Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 2: BMS-955176 (10 mg)
n=7 Participants
Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 3: BMS-955176 (20 mg)
n=4 Participants
Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 4: BMS-955176 (40 mg)
n=4 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 9: BMS-955176 (80 mg)
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 10: BMS-955176 (120 mg)
Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir
Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part C-Group 8: BMS-955176 (40 mg)
Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part C-Group 13: BMS-955176 (120 mg)
Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade B
Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade C
Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part B
CD4+
|
-133.2 Cells/microliter
Standard Deviation 84.14
|
-106.4 Cells/microliter
Standard Deviation 166.59
|
33 Cells/microliter
Standard Deviation 144.79
|
-89 Cells/microliter
Standard Deviation 35.71
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part B
CD8+
|
-442.8 Cells/microliter
Standard Deviation 243.99
|
-466.1 Cells/microliter
Standard Deviation 491.21
|
-216.3 Cells/microliter
Standard Deviation 287.06
|
-147 Cells/microliter
Standard Deviation 140.67
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 24Population: All Treated Subjects Population. Only those participants with data available at the specified time points were analyzed.
Percent Change in the CD4+ and CD8+ cell counts from Baseline were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values.
Outcome measures
| Measure |
Part A-Group 1: BMS-955176 (5 mg)
n=6 Participants
Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 2: BMS-955176 (10 mg)
n=7 Participants
Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 3: BMS-955176 (20 mg)
n=7 Participants
Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 4: BMS-955176 (40 mg)
n=7 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 9: BMS-955176 (80 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 10: BMS-955176 (120 mg)
n=7 Participants
Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir
n=6 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir
n=6 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
n=9 Participants
Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
n=4 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part C-Group 8: BMS-955176 (40 mg)
Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part C-Group 13: BMS-955176 (120 mg)
Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade B
Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade C
Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C
CD4+
|
2.33 Percent change
Standard Deviation 2.944
|
0.29 Percent change
Standard Deviation 2.215
|
-1.29 Percent change
Standard Deviation 5.057
|
0.86 Percent change
Standard Deviation 3.288
|
2.13 Percent change
Standard Deviation 3.399
|
0.29 Percent change
Standard Deviation 2.87
|
0.5 Percent change
Standard Deviation 3.017
|
3.17 Percent change
Standard Deviation 3.371
|
-0.22 Percent change
Standard Deviation 3.93
|
2.75 Percent change
Standard Deviation 3.775
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C
CD8+
|
1.17 Percent change
Standard Deviation 2.401
|
0.43 Percent change
Standard Deviation 3.207
|
0 Percent change
Standard Deviation 6.325
|
1 Percent change
Standard Deviation 3.225
|
-0.25 Percent change
Standard Deviation 5.064
|
-2.29 Percent change
Standard Deviation 2.812
|
0 Percent change
Standard Deviation 1.871
|
-4.25 Percent change
Standard Deviation 3.775
|
1.75 Percent change
Standard Deviation 4.2
|
-1.33 Percent change
Standard Deviation 5.132
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 42Population: All Treated Subjects Population. Only those participants with data available at the specified time points were analyzed.
Percent Change in the CD4+ and CD8+ cell counts from Baseline were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values.
Outcome measures
| Measure |
Part A-Group 1: BMS-955176 (5 mg)
n=5 Participants
Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 2: BMS-955176 (10 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 3: BMS-955176 (20 mg)
n=4 Participants
Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 4: BMS-955176 (40 mg)
n=4 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 9: BMS-955176 (80 mg)
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 10: BMS-955176 (120 mg)
Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir
Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part C-Group 8: BMS-955176 (40 mg)
Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part C-Group 13: BMS-955176 (120 mg)
Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade B
Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade C
Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part B
CD4+
|
2.4 Percent change
Standard Deviation 2.881
|
3.25 Percent change
Standard Deviation 3.105
|
4.75 Percent change
Standard Deviation 2.217
|
-0.75 Percent change
Standard Deviation 1.893
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part B
CD8+
|
-2.8 Percent change
Standard Deviation 1.924
|
-6.25 Percent change
Standard Deviation 4.464
|
-3.75 Percent change
Standard Deviation 2.062
|
-1.25 Percent change
Standard Deviation 2.217
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose Day 1 and Day 28Population: Pharmacokinetic Population.
Tmax was directly determined from concentration time data.
Outcome measures
| Measure |
Part A-Group 1: BMS-955176 (5 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 2: BMS-955176 (10 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 3: BMS-955176 (20 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 4: BMS-955176 (40 mg)
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 9: BMS-955176 (80 mg)
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 10: BMS-955176 (120 mg)
Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir
Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part C-Group 8: BMS-955176 (40 mg)
Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part C-Group 13: BMS-955176 (120 mg)
Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade B
Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade C
Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) - Part B
Day 1
|
5.01 Hours
Interval 3.0 to 12.0
|
5.05 Hours
Interval 4.0 to 12.0
|
5 Hours
Interval 5.0 to 6.0
|
—
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—
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—
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—
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—
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—
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—
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Time to Reach Maximum Plasma Concentration (Tmax) - Part B
Day 28
|
4.5 Hours
Interval 0.0 to 12.0
|
5 Hours
Interval 4.0 to 6.02
|
4.5 Hours
Interval 3.0 to 6.0
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: Pre-dose Day 1 and Day 10Population: Pharmacokinetic Population.
Cmax was defined as the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Outcome measures
| Measure |
Part A-Group 1: BMS-955176 (5 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 2: BMS-955176 (10 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 3: BMS-955176 (20 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 4: BMS-955176 (40 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 9: BMS-955176 (80 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 10: BMS-955176 (120 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir
n=7 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part C-Group 8: BMS-955176 (40 mg)
Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part C-Group 13: BMS-955176 (120 mg)
Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade B
Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade C
Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentrations (Cmax) - Part A and C
Day 1
|
79.376 Nanogram/milliliter
Geometric Coefficient of Variation 37.6
|
201.498 Nanogram/milliliter
Geometric Coefficient of Variation 21.1
|
349.466 Nanogram/milliliter
Geometric Coefficient of Variation 23.2
|
791.317 Nanogram/milliliter
Geometric Coefficient of Variation 46.8
|
1155.448 Nanogram/milliliter
Geometric Coefficient of Variation 27.1
|
1515.389 Nanogram/milliliter
Geometric Coefficient of Variation 27.4
|
793.569 Nanogram/milliliter
Geometric Coefficient of Variation 21.2
|
1907.747 Nanogram/milliliter
Geometric Coefficient of Variation 38.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentrations (Cmax) - Part A and C
Day 10
|
170.778 Nanogram/milliliter
Geometric Coefficient of Variation 20.8
|
337.379 Nanogram/milliliter
Geometric Coefficient of Variation 20.9
|
705.073 Nanogram/milliliter
Geometric Coefficient of Variation 15.4
|
1476.166 Nanogram/milliliter
Geometric Coefficient of Variation 17.2
|
2466.447 Nanogram/milliliter
Geometric Coefficient of Variation 22.1
|
2809.671 Nanogram/milliliter
Geometric Coefficient of Variation 25.5
|
1560.122 Nanogram/milliliter
Geometric Coefficient of Variation 17.4
|
3377.967 Nanogram/milliliter
Geometric Coefficient of Variation 32.8
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 hours post-dosePopulation: Pharmacokinetic Population.
C24 was defined as the plasma concentration of BMS-955176 at 24 hours post-dose.
Outcome measures
| Measure |
Part A-Group 1: BMS-955176 (5 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 2: BMS-955176 (10 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 3: BMS-955176 (20 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 4: BMS-955176 (40 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 9: BMS-955176 (80 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 10: BMS-955176 (120 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir
n=7 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part C-Group 8: BMS-955176 (40 mg)
Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part C-Group 13: BMS-955176 (120 mg)
Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade B
Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade C
Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C
Day 1
|
34.946 Nanogram/milliliter
Geometric Coefficient of Variation 28.4
|
79.002 Nanogram/milliliter
Geometric Coefficient of Variation 27.2
|
154.5 Nanogram/milliliter
Geometric Coefficient of Variation 23.7
|
286.268 Nanogram/milliliter
Geometric Coefficient of Variation 15.6
|
482.349 Nanogram/milliliter
Geometric Coefficient of Variation 34.3
|
624.745 Nanogram/milliliter
Geometric Coefficient of Variation 24.6
|
339.173 Nanogram/milliliter
Geometric Coefficient of Variation 30.1
|
865.867 Nanogram/milliliter
Geometric Coefficient of Variation 41
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C
Day 10
|
81.642 Nanogram/milliliter
Geometric Coefficient of Variation 23.1
|
138.775 Nanogram/milliliter
Geometric Coefficient of Variation 34.1
|
325.934 Nanogram/milliliter
Geometric Coefficient of Variation 19.4
|
713.077 Nanogram/milliliter
Geometric Coefficient of Variation 21.9
|
1150.397 Nanogram/milliliter
Geometric Coefficient of Variation 31.5
|
1288.985 Nanogram/milliliter
Geometric Coefficient of Variation 26.8
|
779.438 Nanogram/milliliter
Geometric Coefficient of Variation 24.6
|
1691.306 Nanogram/milliliter
Geometric Coefficient of Variation 29
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose Day 1 and Day 28Population: Pharmacokinetic Population.
Cmax was defined as the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Outcome measures
| Measure |
Part A-Group 1: BMS-955176 (5 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 2: BMS-955176 (10 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 3: BMS-955176 (20 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 4: BMS-955176 (40 mg)
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 9: BMS-955176 (80 mg)
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 10: BMS-955176 (120 mg)
Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir
Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part C-Group 8: BMS-955176 (40 mg)
Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part C-Group 13: BMS-955176 (120 mg)
Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade B
Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade C
Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentrations (Cmax) - Part B
Day 1
|
695.596 Nanogram/milliliter
Geometric Coefficient of Variation 9.52
|
770.975 Nanogram/milliliter
Geometric Coefficient of Variation 28.2
|
1493.336 Nanogram/milliliter
Geometric Coefficient of Variation 24
|
—
|
—
|
—
|
—
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—
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—
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—
|
—
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—
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—
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—
|
|
Maximum Observed Plasma Concentrations (Cmax) - Part B
Day 28
|
1667.817 Nanogram/milliliter
Geometric Coefficient of Variation 30.2
|
1852 Nanogram/milliliter
Geometric Coefficient of Variation 33.6
|
3159.181 Nanogram/milliliter
Geometric Coefficient of Variation 22.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 hours post-dosePopulation: Pharmacokinetic Population.
C24 was defined as the plasma concentration of BMS-955176 at 24 hours post-dose.
Outcome measures
| Measure |
Part A-Group 1: BMS-955176 (5 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 2: BMS-955176 (10 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 3: BMS-955176 (20 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 4: BMS-955176 (40 mg)
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 9: BMS-955176 (80 mg)
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 10: BMS-955176 (120 mg)
Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir
Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part C-Group 8: BMS-955176 (40 mg)
Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part C-Group 13: BMS-955176 (120 mg)
Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade B
Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade C
Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration 24 Hours Post-Dose (C24) - Part B
Day 1
|
462.312 Nanogram/milliliter
Geometric Coefficient of Variation 25
|
520.048 Nanogram/milliliter
Geometric Coefficient of Variation 27.7
|
899.364 Nanogram/milliliter
Geometric Coefficient of Variation 21.2
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
Plasma Concentration 24 Hours Post-Dose (C24) - Part B
Day 28
|
1099.313 Nanogram/milliliter
Geometric Coefficient of Variation 37
|
1163.177 Nanogram/milliliter
Geometric Coefficient of Variation 30.9
|
2010.679 Nanogram/milliliter
Geometric Coefficient of Variation 19.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose Day 1 and Day 10Population: Pharmacokinetic Population.
AUC(tau) was defined as the area under the plasma concentration - time curve over the dosing interval.
Outcome measures
| Measure |
Part A-Group 1: BMS-955176 (5 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 2: BMS-955176 (10 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 3: BMS-955176 (20 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 4: BMS-955176 (40 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 9: BMS-955176 (80 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 10: BMS-955176 (120 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir
n=7 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part C-Group 8: BMS-955176 (40 mg)
Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part C-Group 13: BMS-955176 (120 mg)
Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade B
Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade C
Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C
Day 1
|
1151.062 Nanogram*hour/milliliter
Geometric Coefficient of Variation 32.2
|
2869.626 Nanogram*hour/milliliter
Geometric Coefficient of Variation 21.3
|
5132.951 Nanogram*hour/milliliter
Geometric Coefficient of Variation 21.5
|
10088.23 Nanogram*hour/milliliter
Geometric Coefficient of Variation 23.1
|
17057.26 Nanogram*hour/milliliter
Geometric Coefficient of Variation 29
|
21872.72 Nanogram*hour/milliliter
Geometric Coefficient of Variation 27
|
10936.9 Nanogram*hour/milliliter
Geometric Coefficient of Variation 29.9
|
26753.74 Nanogram*hour/milliliter
Geometric Coefficient of Variation 35.9
|
—
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—
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—
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—
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—
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—
|
|
Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C
Day 10
|
2720.237 Nanogram*hour/milliliter
Geometric Coefficient of Variation 20.7
|
5168.553 Nanogram*hour/milliliter
Geometric Coefficient of Variation 23.6
|
11751.82 Nanogram*hour/milliliter
Geometric Coefficient of Variation 15.1
|
22984.83 Nanogram*hour/milliliter
Geometric Coefficient of Variation 17.2
|
39341.11 Nanogram*hour/milliliter
Geometric Coefficient of Variation 24.2
|
44182.4 Nanogram*hour/milliliter
Geometric Coefficient of Variation 27
|
25556.64 Nanogram*hour/milliliter
Geometric Coefficient of Variation 20.4
|
53972.71 Nanogram*hour/milliliter
Geometric Coefficient of Variation 30.2
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose Day 1 and Day 28Population: Pharmacokinetic Population.
AUC(tau) was defined as the area under the plasma concentration - time curve over the dosing interval.
Outcome measures
| Measure |
Part A-Group 1: BMS-955176 (5 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 2: BMS-955176 (10 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 3: BMS-955176 (20 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 4: BMS-955176 (40 mg)
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 9: BMS-955176 (80 mg)
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 10: BMS-955176 (120 mg)
Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir
Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part C-Group 8: BMS-955176 (40 mg)
Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part C-Group 13: BMS-955176 (120 mg)
Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade B
Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade C
Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC[Tau]) - Part B
Day 1
|
12147.23 Nanogram*hour/milliliter
Geometric Coefficient of Variation 15.2
|
12954.8 Nanogram*hour/milliliter
Geometric Coefficient of Variation 26.2
|
24478.35 Nanogram*hour/milliliter
Geometric Coefficient of Variation 22.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC[Tau]) - Part B
Day 28
|
31406.32 Nanogram*hour/milliliter
Geometric Coefficient of Variation 31.7
|
34225.08 Nanogram*hour/milliliter
Geometric Coefficient of Variation 30.6
|
59915.72 Nanogram*hour/milliliter
Geometric Coefficient of Variation 16.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 10Population: Pharmacokinetic Population.
Accumulation index was calculated by dividing the AUC(tau) or Cmax or C24 of BMS-955176 on Day 10 by the AUC(TAU) or Cmax or C24, respectively, of BMS-955176 on Day 1.
Outcome measures
| Measure |
Part A-Group 1: BMS-955176 (5 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 2: BMS-955176 (10 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 3: BMS-955176 (20 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 4: BMS-955176 (40 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 9: BMS-955176 (80 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 10: BMS-955176 (120 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir
n=7 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part C-Group 8: BMS-955176 (40 mg)
Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part C-Group 13: BMS-955176 (120 mg)
Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade B
Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade C
Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Accumulation Index (AI): Part A and C
Cmax
|
2.152 Ratio
Geometric Coefficient of Variation 42.9
|
1.674 Ratio
Geometric Coefficient of Variation 31.1
|
2.018 Ratio
Geometric Coefficient of Variation 39.8
|
1.856 Ratio
Geometric Coefficient of Variation 33.6
|
2.135 Ratio
Geometric Coefficient of Variation 16.6
|
1.854 Ratio
Geometric Coefficient of Variation 22.7
|
1.966 Ratio
Geometric Coefficient of Variation 17.2
|
1.771 Ratio
Geometric Coefficient of Variation 42.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Accumulation Index (AI): Part A and C
C24
|
2.336 Ratio
Geometric Coefficient of Variation 21.9
|
1.757 Ratio
Geometric Coefficient of Variation 35
|
2.11 Ratio
Geometric Coefficient of Variation 29.5
|
2.491 Ratio
Geometric Coefficient of Variation 24.9
|
2.385 Ratio
Geometric Coefficient of Variation 25.1
|
2.063 Ratio
Geometric Coefficient of Variation 19.3
|
2.298 Ratio
Geometric Coefficient of Variation 28.4
|
1.953 Ratio
Geometric Coefficient of Variation 42.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Accumulation Index (AI): Part A and C
AUC
|
2.363 Ratio
Geometric Coefficient of Variation 25.9
|
1.801 Ratio
Geometric Coefficient of Variation 30.4
|
2.289 Ratio
Geometric Coefficient of Variation 39.7
|
2.278 Ratio
Geometric Coefficient of Variation 28.2
|
2.306 Ratio
Geometric Coefficient of Variation 19
|
2.02 Ratio
Geometric Coefficient of Variation 19.7
|
2.337 Ratio
Geometric Coefficient of Variation 26.1
|
2.017 Ratio
Geometric Coefficient of Variation 39
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 10Population: Pharmacokinetic Population.
Apparent total body clearance was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7).
Outcome measures
| Measure |
Part A-Group 1: BMS-955176 (5 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 2: BMS-955176 (10 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 3: BMS-955176 (20 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 4: BMS-955176 (40 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 9: BMS-955176 (80 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 10: BMS-955176 (120 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir
n=7 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part C-Group 8: BMS-955176 (40 mg)
Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part C-Group 13: BMS-955176 (120 mg)
Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade B
Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade C
Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Total Body Clearance: Part A and C
|
30.635 Milliliters/minute
Geometric Coefficient of Variation 18.3
|
32.246 Milliliters/minute
Geometric Coefficient of Variation 28
|
28.364 Milliliters/minute
Geometric Coefficient of Variation 15.5
|
29.005 Milliliters/minute
Geometric Coefficient of Variation 18.8
|
33.892 Milliliters/minute
Geometric Coefficient of Variation 23.8
|
45.267 Milliliters/minute
Geometric Coefficient of Variation 34
|
26.086 Milliliters/minute
Geometric Coefficient of Variation 21.3
|
37.056 Milliliters/minute
Geometric Coefficient of Variation 33.7
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 10Population: Pharmacokinetic Population.
DF was calculated as the difference between Cmax and Cmin divided by Css-avg. DF was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7).
Outcome measures
| Measure |
Part A-Group 1: BMS-955176 (5 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 2: BMS-955176 (10 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 3: BMS-955176 (20 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 4: BMS-955176 (40 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 9: BMS-955176 (80 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 10: BMS-955176 (120 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir
n=7 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part C-Group 8: BMS-955176 (40 mg)
Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part C-Group 13: BMS-955176 (120 mg)
Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade B
Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade C
Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Degree of Fluctuation (DF): Part A and C
|
0.766 Ratio
Geometric Coefficient of Variation 29.4
|
0.912 Ratio
Geometric Coefficient of Variation 15.2
|
0.758 Ratio
Geometric Coefficient of Variation 20.2
|
0.78 Ratio
Geometric Coefficient of Variation 22.1
|
0.779 Ratio
Geometric Coefficient of Variation 28.5
|
0.818 Ratio
Geometric Coefficient of Variation 17.1
|
0.723 Ratio
Geometric Coefficient of Variation 13.7
|
0.727 Ratio
Geometric Coefficient of Variation 24.5
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 10Population: Pharmacokinetic Population.
Css-avg was calculated by the quotient of AUC(TAU) and the dosing interval (24 h). Css-avg was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7).
Outcome measures
| Measure |
Part A-Group 1: BMS-955176 (5 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 2: BMS-955176 (10 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 3: BMS-955176 (20 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 4: BMS-955176 (40 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 9: BMS-955176 (80 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 10: BMS-955176 (120 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir
n=7 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part C-Group 8: BMS-955176 (40 mg)
Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part C-Group 13: BMS-955176 (120 mg)
Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade B
Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade C
Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Average Observed Plasma Concentration at Steady State (Css-avg): Part A and C
|
113.326 Nanogram/milliliter
Geometric Coefficient of Variation 20.7
|
215.111 Nanogram/milliliter
Geometric Coefficient of Variation 23.8
|
489.507 Nanogram/milliliter
Geometric Coefficient of Variation 15.1
|
956.222 Nanogram/milliliter
Geometric Coefficient of Variation 17.3
|
1639.471 Nanogram/milliliter
Geometric Coefficient of Variation 24.2
|
1841.413 Nanogram/milliliter
Geometric Coefficient of Variation 27
|
1065.435 Nanogram/milliliter
Geometric Coefficient of Variation 19.9
|
2256.793 Nanogram/milliliter
Geometric Coefficient of Variation 30.2
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 10Population: Pharmacokinetic Population
Half-life of the terminal log-linear phase, (T-half), was calculated as natural logarithm of 2 (ln2)/λ, where λ is the absolute value of the slope of the terminal log-linear phase. T-half was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7).
Outcome measures
| Measure |
Part A-Group 1: BMS-955176 (5 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 2: BMS-955176 (10 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 3: BMS-955176 (20 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 4: BMS-955176 (40 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 9: BMS-955176 (80 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 10: BMS-955176 (120 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir
n=7 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part C-Group 8: BMS-955176 (40 mg)
Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part C-Group 13: BMS-955176 (120 mg)
Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade B
Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade C
Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Half-life: Part A and C
|
32.134 Hours
Interval 25.45 to 46.45
|
31.967 Hours
Interval 23.97 to 43.02
|
27.382 Hours
Interval 24.0 to 41.59
|
33.475 Hours
Interval 25.79 to 42.39
|
29.171 Hours
Interval 24.32 to 38.02
|
34.574 Hours
Interval 29.01 to 39.69
|
31.565 Hours
Interval 24.39 to 51.64
|
35.278 Hours
Interval 26.65 to 38.71
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to up to end of the study (Day 42)Population: All Treated Subjects Population.
Laboratory abnormalities were determined and graded using the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0, December 2004.
Outcome measures
| Measure |
Part A-Group 1: BMS-955176 (5 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 2: BMS-955176 (10 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 3: BMS-955176 (20 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 4: BMS-955176 (40 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 9: BMS-955176 (80 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 10: BMS-955176 (120 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
n=4 Participants
Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part C-Group 8: BMS-955176 (40 mg)
n=8 Participants
Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part C-Group 13: BMS-955176 (120 mg)
n=7 Participants
Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade B
n=12 Participants
Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade C
n=4 Participants
Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline
Neutrophils (Absolute)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline
Bilirubin (Total)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to end of the study (Day 42)Population: All Treated Subjects Population.
Heart rate was measured after the participants had been seated quietly for at least 5 minutes. Criteria used to determine heart rate that are outside of a pre-specified range, where changes from Baseline are based on matched postural positions and are calculated as parameter value - Baseline parameter value: Value \>100 and change from Baseline \> 30, or Value \< 55 and change from Baseline \< -15.
Outcome measures
| Measure |
Part A-Group 1: BMS-955176 (5 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 2: BMS-955176 (10 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 3: BMS-955176 (20 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 4: BMS-955176 (40 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 9: BMS-955176 (80 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 10: BMS-955176 (120 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
n=4 Participants
Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part C-Group 8: BMS-955176 (40 mg)
n=8 Participants
Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part C-Group 13: BMS-955176 (120 mg)
n=7 Participants
Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade B
n=12 Participants
Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade C
n=4 Participants
Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Heart Rate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to end of the study (Day 42)Population: All Treated Subjects Population.
Participants with out of range ECG intervals were summarized. Criteria used to determine ECG results that are outside of a pre-specified range: PR (milliseconds \[msec\]): Value \>200; QRS (msec): Value \>120; QT (msec): Value \>500 or change from Baseline \>30; corrected QT interval Fridericia's formula (QTcF) (msec): Value \>450 or change from Baseline \>30.
Outcome measures
| Measure |
Part A-Group 1: BMS-955176 (5 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 2: BMS-955176 (10 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 3: BMS-955176 (20 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 4: BMS-955176 (40 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 9: BMS-955176 (80 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 10: BMS-955176 (120 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
n=4 Participants
Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part C-Group 8: BMS-955176 (40 mg)
n=8 Participants
Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part C-Group 13: BMS-955176 (120 mg)
n=7 Participants
Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade B
n=12 Participants
Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade C
n=4 Participants
Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
PR > 200 msec
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
QRS > 120 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
QT > 500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
QTcB > 450 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
QTcF > 450 msec
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to end of the study (Day 42)Population: All Treated Subjects Population.
Participants with abnormal changes in physical examination is presented.
Outcome measures
| Measure |
Part A-Group 1: BMS-955176 (5 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 2: BMS-955176 (10 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 3: BMS-955176 (20 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 4: BMS-955176 (40 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 9: BMS-955176 (80 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 10: BMS-955176 (120 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
n=4 Participants
Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part C-Group 8: BMS-955176 (40 mg)
n=8 Participants
Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part C-Group 13: BMS-955176 (120 mg)
n=7 Participants
Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade B
n=12 Participants
Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade C
n=4 Participants
Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Changes in Physical Examination
Weight
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Changes in Physical Examination
Body mass index
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Changes in Physical Examination
Height
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to end of the study (Day 42)Population: All Treated Subjects Population.
Systolic BP (millimeter of mercury \[mmHg\]): value \>140 and change from Baseline \>20, or value \<90 and change from Baseline \<-20; Diastolic BP (mmHg): value \>90 and change from Baseline \>10, or value \<55 and change from Baseline \<-10.
Outcome measures
| Measure |
Part A-Group 1: BMS-955176 (5 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 2: BMS-955176 (10 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 3: BMS-955176 (20 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 4: BMS-955176 (40 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 9: BMS-955176 (80 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 10: BMS-955176 (120 mg)
n=8 Participants
Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
n=4 Participants
Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
n=8 Participants
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part C-Group 8: BMS-955176 (40 mg)
n=8 Participants
Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part C-Group 13: BMS-955176 (120 mg)
n=7 Participants
Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade B
n=12 Participants
Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade C
n=4 Participants
Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Part A-Group 1: BMS-955176 (5 mg)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part A-Group 2: BMS-955176 (10 mg)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part A-Group 3: BMS-955176 (20 mg)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part A-Group 4: BMS-955176 (40 mg)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part A-Group 9: BMS-955176 (80 mg)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part A-Group 10: BMS-955176 (120 mg)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo Clade B
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part C-Group 8: BMS-955176 (40 mg)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part C-Group 13: BMS-955176 (120 mg)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo Clade C
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A-Group 1: BMS-955176 (5 mg)
n=8 participants at risk
Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 2: BMS-955176 (10 mg)
n=8 participants at risk
Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 3: BMS-955176 (20 mg)
n=8 participants at risk
Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 4: BMS-955176 (40 mg)
n=8 participants at risk
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 9: BMS-955176 (80 mg)
n=8 participants at risk
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part A-Group 10: BMS-955176 (120 mg)
n=8 participants at risk
Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade B
n=12 participants at risk
Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir
n=8 participants at risk
Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir
n=8 participants at risk
Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
n=4 participants at risk
Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
n=8 participants at risk
Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2\*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
|
Part C-Group 8: BMS-955176 (40 mg)
n=8 participants at risk
Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Part C-Group 13: BMS-955176 (120 mg)
n=7 participants at risk
Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
Placebo Clade C
n=4 participants at risk
Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
8.3%
1/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
8.3%
1/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Vascular disorders
Hypertension
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
8.3%
1/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
General disorders
Fatigue
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
8.3%
1/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
25.0%
1/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
25.0%
1/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
General disorders
Nodule
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
General disorders
Malaise
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
14.3%
1/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
General disorders
Chills
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
8.3%
1/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
General disorders
Asthenia
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
General disorders
Catheter site related reaction
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
General disorders
Sensation of foreign body
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
8.3%
1/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Psychiatric disorders
Abnormal dreams
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
37.5%
3/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
37.5%
3/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
37.5%
3/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
25.0%
3/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
37.5%
3/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
37.5%
3/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
37.5%
3/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
25.0%
2/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Psychiatric disorders
Sleep disorder
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
25.0%
1/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
25.0%
2/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
25.0%
1/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
14.3%
1/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
75.0%
6/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
100.0%
8/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
100.0%
4/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Investigations
Weight decreased
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
8.3%
1/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Investigations
Blood bilirubin unconjugated increased
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Investigations
Body temperature increased
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
8.3%
1/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
25.0%
2/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
14.3%
1/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
25.0%
2/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
14.3%
1/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
25.0%
1/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
8.3%
1/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
37.5%
3/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
62.5%
5/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
50.0%
4/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
62.5%
5/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
41.7%
5/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
62.5%
5/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
37.5%
3/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
50.0%
2/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
50.0%
4/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
50.0%
4/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
28.6%
2/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
75.0%
3/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
8.3%
1/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
25.0%
2/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
8.3%
1/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
8.3%
1/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Eye disorders
Ocular icterus
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
37.5%
3/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Eye disorders
Eye pain
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Eye disorders
Dry eye
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Eye disorders
Eye irritation
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Eye disorders
Foreign body sensation in eyes
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
8.3%
1/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Ear and labyrinth disorders
External ear pain
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
25.0%
2/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
37.5%
3/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
25.0%
2/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
50.0%
2/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
37.5%
3/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
28.6%
2/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
8.3%
1/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
25.0%
2/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
25.0%
1/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
8.3%
1/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
8.3%
1/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
25.0%
1/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
14.3%
1/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
8.3%
1/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
25.0%
1/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
8.3%
1/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
25.0%
1/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
8.3%
1/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Gastrointestinal disorders
Abdominal distension
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Gastrointestinal disorders
Faeces hard
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
8.3%
1/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
25.0%
1/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Gastrointestinal disorders
Haemorrhoids thrombosed
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
8.3%
1/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
14.3%
1/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
25.0%
2/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
50.0%
4/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
75.0%
3/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
37.5%
3/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
8.3%
1/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
25.0%
2/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
25.0%
2/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
50.0%
2/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
25.0%
1/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
8.3%
1/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
14.3%
1/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
14.3%
1/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
14.3%
1/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
8.3%
1/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
25.0%
1/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
8.3%
1/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
25.0%
1/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
25.0%
1/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
25.0%
1/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
25.0%
2/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
16.7%
2/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
50.0%
2/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Infections and infestations
Candida infection
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
14.3%
1/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
14.3%
1/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Infections and infestations
Gonorrhoea
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
12.5%
1/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/12 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/8 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/7 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
0.00%
0/4 • Day 1 to up to end of the study (Day 42)
All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER