Infection, Human Immunodeficiency Virus, HIV Infections
Conditions
Brief summary
The primary purpose of this study is to study the safety and tolerability of a HIV drug and to evaluate a decrease of HIV-1 virus level in blood after treatments in HIV-1 infected patients
Detailed description
Masking: Open-Part B. Double Blind-Parts A and C Gender: Both female and male participants for Parts A and C. Male participants for Part B. HIV = Human Immunodeficiency Virus RNA = Ribonucleic acid
Interventions
DRUGBMS-955176
BMS-955176
DRUGPlacebo matching with BMS-955176
Placebo matching with BMS-955176
DRUGAtazanavir
Atazanavir
DRUGRitonavir
Ritonavir
DRUGTenofovir
Tenofovir
DRUGEmtricitabine
Emtricitabine
Sponsors
GlaxoSmithKline
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Age 18-55 years inclusive * Men and women: (Parts A and C); men only (Part B) * Women of childbearing potential (WOCBP) must not be pregnant and nursing * BMI: 18.0-35.0 kg/m2 * Subjects are infected with HIV-1 (clades B or C) and meet following criteria at the screening: i) Plasma HIV-1 RNA ≥5,000 copies/mL; ii) Antiretroviral treatment naive (defined as \<1 week of ARV treatment) or ART-experienced (protease inhibitor and/or maturation inhibitor naive); iii) Subjects are not eligible for HIV-1 treatment based on the United States Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents or have declined initiation of cART iv) CD4+ lymphocyte measurement ≥200 cells/μL; v) In Parts A and B, all subjects are infected with HIV-1 clade B vi) In Part C, all subjects are infected with HIV-1 clade C
Exclusion criteria
* History of genotypic and/or phenotypic drug resistance testing showing resistance to protease inhibitors * Any significant acute or chronic medical illness which is not stable or is not controlled with medication or not consistent with HIV-1 infection * Receive antiretroviral treatment within 12 weeks prior to screening * Currently co-infected with hepatitis C or hepatitis B * Previously received an HIV maturation inhibitor or HIV protease inhibitor * Current or recent (within 3 months of study drug administration) gastrointestinal disease * Any major surgery within 4 weeks of study drug administration * Acute diarrhea lasting ≥1 day, within 3 weeks prior to randomization * Subjects with history of Gilbert's syndrome * Subjects previously received an HIV maturation inhibitor or HIV protease inhibitor * A personal history of clinically relevant cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or additional risk factors for torsades de pointes. A personal or family history of long QT syndrome * Patients who are unwilling to practice adequate infection protection during and after study participation to minimize potential for spread of HIV infection, including HIV which may have developed resistance to HIV maturation inhibitor and/or ATV * Any gastrointestinal surgery that could impact upon the absorption of study drug * Smoking \>10 cigarettes per day * PR ≥210 msec; QRS ≥120 msec; QT ≥500 msec; and QTcF ≥470 msec for women and ≥450 msec for men * Evidence of second or third degree heart block prior to study drug * Absolute Neutrophil Count \<(ANC) 0.7 x lower limit of normal (LLN) * Hemoglobin \<0.8 x LLN * Alanine aminotransferase (ALT) \>1.25 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) \>1.25 x ULN * Total Bilirubin \>1.25 x ULN * Creatinine clearance \<60 mL/mim * Positive urine screen for drugs of abuse without a valid prescription (subjects positive for cannabinoids and/or amphetamines will be included) * Positive blood screen for hepatitis C virus (HCV) RNA, hepatitis B surface antigen (consistent with active or chronic hepatitis B), or HIV-2 antibody * History of any significant drug allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11 | Baseline (Day 1) and Day 11 after the final dose with BMS-955176 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 1 to end of the study (Day 42) | 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. |
| Maximum Decline From Baseline in Log10 HIV-1 RNA - Part A and C | Baseline (Day 1) up to Day 24 | 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. |
| Maximum Decline From Baseline in Log10 HIV-1 RNA - Part B | Baseline (Day 1) up to Day 42 | 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. |
| Time to Maximum Decline in Log 10 HIV-1 RNA - Part A and C | Baseline (Day 1) up to Day 24 | 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. |
| Time to Maximum Decline in Log 10 HIV-1 RNA - Part B | Baseline (Day 1) up to Day 42 | 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. |
| Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C | Baseline (Day 1) up to Day 24 | 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. |
| Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part B | Baseline (Day 1) up to Day 42 | 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. |
| Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C | Baseline (Day 1) up to Day 24 | 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. |
| Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part B | Baseline (Day 1) up to Day 42 | 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. |
| Time to Reach Maximum Plasma Concentration (Tmax) - Part B | Pre-dose Day 1 and Day 28 | Tmax was directly determined from concentration time data. |
| Maximum Observed Plasma Concentrations (Cmax) - Part A and C | Pre-dose Day 1 and Day 10 | Cmax was defined as the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. |
| Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C | 24 hours post-dose | C24 was defined as the plasma concentration of BMS-955176 at 24 hours post-dose. |
| Maximum Observed Plasma Concentrations (Cmax) - Part B | Pre-dose Day 1 and Day 28 | Cmax was defined as the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. |
| Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C | Pre-dose Day 1 and Day 10 | Time to reach the maximum plasma concentration was directly determined from concentration time data. |
| Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C | Pre-dose Day 1 and Day 10 | AUC(tau) was defined as the area under the plasma concentration - time curve over the dosing interval. |
| Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC[Tau]) - Part B | Pre-dose Day 1 and Day 28 | AUC(tau) was defined as the area under the plasma concentration - time curve over the dosing interval. |
| Accumulation Index (AI): Part A and C | Baseline and Day 10 | 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. |
| Apparent Total Body Clearance: Part A and C | Baseline (Day 1) to Day 10 | 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). |
| Degree of Fluctuation (DF): Part A and C | Baseline (Day 1) to Day 10 | 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). |
| Average Observed Plasma Concentration at Steady State (Css-avg): Part A and C | Baseline (Day 1) to Day 10 | 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). |
| Plasma Half-life: Part A and C | Baseline (Day 1) to Day 10 | 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). |
| Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline | Day 1 to up to end of the study (Day 42) | 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. |
| Number of Participants With Clinically Significant Changes in Heart Rate | Day 1 to end of the study (Day 42) | 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. |
| Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | Day 1 to end of the study (Day 42) | 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. |
| Number of Participants With Abnormal Changes in Physical Examination | Day 1 to end of the study (Day 42) | Participants with abnormal changes in physical examination is presented. |
| Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1 to end of the study (Day 42) | 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. |
| Plasma Concentration 24 Hours Post-Dose (C24) - Part B | 24 hours post-dose | C24 was defined as the plasma concentration of BMS-955176 at 24 hours post-dose. |
Countries
Germany
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Part A-Group 1: BMS-955176 (5 mg) 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. | 8 |
| 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. | 8 |
| 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. | 8 |
| 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. | 8 |
| 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. | 8 |
| 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. | 8 |
| 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. | 12 |
| 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. | 8 |
| 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. | 8 |
| 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. | 4 |
| 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. | 8 |
| 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. | 8 |
| 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. | 7 |
| 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. | 4 |
| Total | 107 |
Baseline characteristics
| Characteristic | Part A-Group 1: BMS-955176 (5 mg) | Part A-Group 2: BMS-955176 (10 mg) | Part A-Group 3: BMS-955176 (20 mg) | Part A-Group 4: BMS-955176 (40 mg) | Part A-Group 9: BMS-955176 (80 mg) | Part A-Group 10: BMS-955176 (120 mg) | Placebo Clade B | Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | Part C-Group 8: BMS-955176 (40 mg) | Part C-Group 13: BMS-955176 (120 mg) | Placebo Clade C | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 41.6 Years STANDARD_DEVIATION 8.73 | 37.5 Years STANDARD_DEVIATION 11.07 | 33.3 Years STANDARD_DEVIATION 7.19 | 39.5 Years STANDARD_DEVIATION 8.09 | 36.3 Years STANDARD_DEVIATION 11.23 | 38.0 Years STANDARD_DEVIATION 9.49 | 36.3 Years STANDARD_DEVIATION 7.12 | 33.0 Years STANDARD_DEVIATION 7.21 | 36.3 Years STANDARD_DEVIATION 9.24 | 32.8 Years STANDARD_DEVIATION 10.21 | 34.3 Years STANDARD_DEVIATION 6.8 | 33.6 Years STANDARD_DEVIATION 7.8 | 35.4 Years STANDARD_DEVIATION 9.59 | 35.3 Years STANDARD_DEVIATION 8.54 | 36.1 Years STANDARD_DEVIATION 8.54 |
| Race/Ethnicity, Customized American Indian/Alaska | 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 | 1 Participants |
| Race/Ethnicity, Customized Black/African American | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 5 Participants | 7 Participants | 3 Participants | 17 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 6 Participants | 7 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 12 Participants | 6 Participants | 8 Participants | 4 Participants | 7 Participants | 2 Participants | 0 Participants | 0 Participants | 84 Participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 2 Participants | 2 Participants | 8 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 12 Participants | 8 Participants | 8 Participants | 4 Participants | 8 Participants | 5 Participants | 5 Participants | 2 Participants | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 12 | 0 / 8 | 0 / 8 | 0 / 4 | 0 / 8 | 0 / 8 | 0 / 7 | 0 / 4 |
| other Total, other adverse events | 5 / 8 | 5 / 8 | 5 / 8 | 6 / 8 | 8 / 8 | 7 / 8 | 9 / 12 | 8 / 8 | 8 / 8 | 4 / 4 | 6 / 8 | 7 / 8 | 6 / 7 | 3 / 4 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 12 | 0 / 8 | 0 / 8 | 0 / 4 | 0 / 8 | 0 / 8 | 0 / 7 | 0 / 4 |
Outcome results
Primary
Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11
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.
Time frame: Baseline (Day 1) and Day 11 after the final dose with BMS-955176
Population: All Treated Subjects Population comprised of all participants who had received at least one dose of study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A-Group 1: BMS-955176 (5 mg) | 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 |
| Part A-Group 2: BMS-955176 (10 mg) | Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11 | -0.567 Log10 copies per milliliter (c/mL) | Standard Deviation 0.5845 |
| Part A-Group 3: BMS-955176 (20 mg) | Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11 | -0.889 Log10 copies per milliliter (c/mL) | Standard Deviation 0.6582 |
| Part A-Group 4: BMS-955176 (40 mg) | Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11 | -1.279 Log10 copies per milliliter (c/mL) | Standard Deviation 0.4596 |
| Part A-Group 9: BMS-955176 (80 mg) | Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11 | -1.339 Log10 copies per milliliter (c/mL) | Standard Deviation 0.29 |
| Part A-Group 10: BMS-955176 (120 mg) | Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11 | -1.326 Log10 copies per milliliter (c/mL) | Standard Deviation 0.3855 |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11 | -1.216 Log10 copies per milliliter (c/mL) | Standard Deviation 0.4366 |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11 | -1.431 Log10 copies per milliliter (c/mL) | Standard Deviation 0.2967 |
| Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11 | -1.544 Log10 copies per milliliter (c/mL) | Standard Deviation 0.4155 |
| Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11 | -1.521 Log10 copies per milliliter (c/mL) | Standard Deviation 0.2651 |
| Part C-Group 8: BMS-955176 (40 mg) | Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11 | -1.29 Log10 copies per milliliter (c/mL) | Standard Deviation 0.3376 |
| Part C-Group 13: BMS-955176 (120 mg) | Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11 | -0.938 Log10 copies per milliliter (c/mL) | Standard Deviation 0.6897 |
| Placebo Clade B | Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11 | 0.118 Log10 copies per milliliter (c/mL) | Standard Deviation 0.5277 |
| Placebo Clade C | Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11 | -0.172 Log10 copies per milliliter (c/mL) | Standard Deviation 0.7876 |
Secondary
Accumulation Index (AI): Part A and C
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.
Time frame: Baseline and Day 10
Population: Pharmacokinetic Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A-Group 1: BMS-955176 (5 mg) | Accumulation Index (AI): Part A and C | Cmax | 2.152 Ratio | Geometric Coefficient of Variation 42.9 |
| Part A-Group 1: BMS-955176 (5 mg) | Accumulation Index (AI): Part A and C | AUC | 2.363 Ratio | Geometric Coefficient of Variation 25.9 |
| Part A-Group 1: BMS-955176 (5 mg) | Accumulation Index (AI): Part A and C | C24 | 2.336 Ratio | Geometric Coefficient of Variation 21.9 |
| Part A-Group 2: BMS-955176 (10 mg) | Accumulation Index (AI): Part A and C | AUC | 1.801 Ratio | Geometric Coefficient of Variation 30.4 |
| Part A-Group 2: BMS-955176 (10 mg) | Accumulation Index (AI): Part A and C | C24 | 1.757 Ratio | Geometric Coefficient of Variation 35 |
| Part A-Group 2: BMS-955176 (10 mg) | Accumulation Index (AI): Part A and C | Cmax | 1.674 Ratio | Geometric Coefficient of Variation 31.1 |
| Part A-Group 3: BMS-955176 (20 mg) | Accumulation Index (AI): Part A and C | AUC | 2.289 Ratio | Geometric Coefficient of Variation 39.7 |
| Part A-Group 3: BMS-955176 (20 mg) | Accumulation Index (AI): Part A and C | Cmax | 2.018 Ratio | Geometric Coefficient of Variation 39.8 |
| Part A-Group 3: BMS-955176 (20 mg) | Accumulation Index (AI): Part A and C | C24 | 2.11 Ratio | Geometric Coefficient of Variation 29.5 |
| Part A-Group 4: BMS-955176 (40 mg) | Accumulation Index (AI): Part A and C | Cmax | 1.856 Ratio | Geometric Coefficient of Variation 33.6 |
| Part A-Group 4: BMS-955176 (40 mg) | Accumulation Index (AI): Part A and C | C24 | 2.491 Ratio | Geometric Coefficient of Variation 24.9 |
| Part A-Group 4: BMS-955176 (40 mg) | Accumulation Index (AI): Part A and C | AUC | 2.278 Ratio | Geometric Coefficient of Variation 28.2 |
| Part A-Group 9: BMS-955176 (80 mg) | Accumulation Index (AI): Part A and C | C24 | 2.385 Ratio | Geometric Coefficient of Variation 25.1 |
| Part A-Group 9: BMS-955176 (80 mg) | Accumulation Index (AI): Part A and C | Cmax | 2.135 Ratio | Geometric Coefficient of Variation 16.6 |
| Part A-Group 9: BMS-955176 (80 mg) | Accumulation Index (AI): Part A and C | AUC | 2.306 Ratio | Geometric Coefficient of Variation 19 |
| Part A-Group 10: BMS-955176 (120 mg) | Accumulation Index (AI): Part A and C | C24 | 2.063 Ratio | Geometric Coefficient of Variation 19.3 |
| Part A-Group 10: BMS-955176 (120 mg) | Accumulation Index (AI): Part A and C | Cmax | 1.854 Ratio | Geometric Coefficient of Variation 22.7 |
| Part A-Group 10: BMS-955176 (120 mg) | Accumulation Index (AI): Part A and C | AUC | 2.02 Ratio | Geometric Coefficient of Variation 19.7 |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Accumulation Index (AI): Part A and C | C24 | 2.298 Ratio | Geometric Coefficient of Variation 28.4 |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Accumulation Index (AI): Part A and C | Cmax | 1.966 Ratio | Geometric Coefficient of Variation 17.2 |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Accumulation Index (AI): Part A and C | AUC | 2.337 Ratio | Geometric Coefficient of Variation 26.1 |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Accumulation Index (AI): Part A and C | Cmax | 1.771 Ratio | Geometric Coefficient of Variation 42.6 |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Accumulation Index (AI): Part A and C | C24 | 1.953 Ratio | Geometric Coefficient of Variation 42.1 |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Accumulation Index (AI): Part A and C | AUC | 2.017 Ratio | Geometric Coefficient of Variation 39 |
Secondary
Apparent Total Body Clearance: Part A and C
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).
Time frame: Baseline (Day 1) to Day 10
Population: Pharmacokinetic Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A-Group 1: BMS-955176 (5 mg) | Apparent Total Body Clearance: Part A and C | 30.635 Milliliters/minute | Geometric Coefficient of Variation 18.3 |
| Part A-Group 2: BMS-955176 (10 mg) | Apparent Total Body Clearance: Part A and C | 32.246 Milliliters/minute | Geometric Coefficient of Variation 28 |
| Part A-Group 3: BMS-955176 (20 mg) | Apparent Total Body Clearance: Part A and C | 28.364 Milliliters/minute | Geometric Coefficient of Variation 15.5 |
| Part A-Group 4: BMS-955176 (40 mg) | Apparent Total Body Clearance: Part A and C | 29.005 Milliliters/minute | Geometric Coefficient of Variation 18.8 |
| Part A-Group 9: BMS-955176 (80 mg) | Apparent Total Body Clearance: Part A and C | 33.892 Milliliters/minute | Geometric Coefficient of Variation 23.8 |
| Part A-Group 10: BMS-955176 (120 mg) | Apparent Total Body Clearance: Part A and C | 45.267 Milliliters/minute | Geometric Coefficient of Variation 34 |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Apparent Total Body Clearance: Part A and C | 26.086 Milliliters/minute | Geometric Coefficient of Variation 21.3 |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Apparent Total Body Clearance: Part A and C | 37.056 Milliliters/minute | Geometric Coefficient of Variation 33.7 |
Secondary
Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C
AUC(tau) was defined as the area under the plasma concentration - time curve over the dosing interval.
Time frame: Pre-dose Day 1 and Day 10
Population: Pharmacokinetic Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A-Group 1: BMS-955176 (5 mg) | 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 |
| Part A-Group 1: BMS-955176 (5 mg) | 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 |
| Part A-Group 2: BMS-955176 (10 mg) | Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C | Day 1 | 2869.626 Nanogram*hour/milliliter | Geometric Coefficient of Variation 21.3 |
| Part A-Group 2: BMS-955176 (10 mg) | Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C | Day 10 | 5168.553 Nanogram*hour/milliliter | Geometric Coefficient of Variation 23.6 |
| Part A-Group 3: BMS-955176 (20 mg) | Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C | Day 1 | 5132.951 Nanogram*hour/milliliter | Geometric Coefficient of Variation 21.5 |
| Part A-Group 3: BMS-955176 (20 mg) | Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C | Day 10 | 11751.82 Nanogram*hour/milliliter | Geometric Coefficient of Variation 15.1 |
| Part A-Group 4: BMS-955176 (40 mg) | Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C | Day 1 | 10088.23 Nanogram*hour/milliliter | Geometric Coefficient of Variation 23.1 |
| Part A-Group 4: BMS-955176 (40 mg) | Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C | Day 10 | 22984.83 Nanogram*hour/milliliter | Geometric Coefficient of Variation 17.2 |
| Part A-Group 9: BMS-955176 (80 mg) | Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C | Day 1 | 17057.26 Nanogram*hour/milliliter | Geometric Coefficient of Variation 29 |
| Part A-Group 9: BMS-955176 (80 mg) | Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C | Day 10 | 39341.11 Nanogram*hour/milliliter | Geometric Coefficient of Variation 24.2 |
| Part A-Group 10: BMS-955176 (120 mg) | Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C | Day 1 | 21872.72 Nanogram*hour/milliliter | Geometric Coefficient of Variation 27 |
| Part A-Group 10: BMS-955176 (120 mg) | Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C | Day 10 | 44182.4 Nanogram*hour/milliliter | Geometric Coefficient of Variation 27 |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C | Day 10 | 25556.64 Nanogram*hour/milliliter | Geometric Coefficient of Variation 20.4 |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C | Day 1 | 10936.9 Nanogram*hour/milliliter | Geometric Coefficient of Variation 29.9 |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C | Day 1 | 26753.74 Nanogram*hour/milliliter | Geometric Coefficient of Variation 35.9 |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C | Day 10 | 53972.71 Nanogram*hour/milliliter | Geometric Coefficient of Variation 30.2 |
Secondary
Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC[Tau]) - Part B
AUC(tau) was defined as the area under the plasma concentration - time curve over the dosing interval.
Time frame: Pre-dose Day 1 and Day 28
Population: Pharmacokinetic Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A-Group 1: BMS-955176 (5 mg) | 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 |
| Part A-Group 1: BMS-955176 (5 mg) | 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 |
| Part A-Group 2: BMS-955176 (10 mg) | Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC[Tau]) - Part B | Day 1 | 12954.8 Nanogram*hour/milliliter | Geometric Coefficient of Variation 26.2 |
| Part A-Group 2: BMS-955176 (10 mg) | Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC[Tau]) - Part B | Day 28 | 34225.08 Nanogram*hour/milliliter | Geometric Coefficient of Variation 30.6 |
| Part A-Group 3: BMS-955176 (20 mg) | Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC[Tau]) - Part B | Day 1 | 24478.35 Nanogram*hour/milliliter | Geometric Coefficient of Variation 22.6 |
| Part A-Group 3: BMS-955176 (20 mg) | Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC[Tau]) - Part B | Day 28 | 59915.72 Nanogram*hour/milliliter | Geometric Coefficient of Variation 16.3 |
Secondary
Average Observed Plasma Concentration at Steady State (Css-avg): Part A and C
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).
Time frame: Baseline (Day 1) to Day 10
Population: Pharmacokinetic Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A-Group 1: BMS-955176 (5 mg) | Average Observed Plasma Concentration at Steady State (Css-avg): Part A and C | 113.326 Nanogram/milliliter | Geometric Coefficient of Variation 20.7 |
| Part A-Group 2: BMS-955176 (10 mg) | Average Observed Plasma Concentration at Steady State (Css-avg): Part A and C | 215.111 Nanogram/milliliter | Geometric Coefficient of Variation 23.8 |
| Part A-Group 3: BMS-955176 (20 mg) | Average Observed Plasma Concentration at Steady State (Css-avg): Part A and C | 489.507 Nanogram/milliliter | Geometric Coefficient of Variation 15.1 |
| Part A-Group 4: BMS-955176 (40 mg) | Average Observed Plasma Concentration at Steady State (Css-avg): Part A and C | 956.222 Nanogram/milliliter | Geometric Coefficient of Variation 17.3 |
| Part A-Group 9: BMS-955176 (80 mg) | Average Observed Plasma Concentration at Steady State (Css-avg): Part A and C | 1639.471 Nanogram/milliliter | Geometric Coefficient of Variation 24.2 |
| Part A-Group 10: BMS-955176 (120 mg) | Average Observed Plasma Concentration at Steady State (Css-avg): Part A and C | 1841.413 Nanogram/milliliter | Geometric Coefficient of Variation 27 |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Average Observed Plasma Concentration at Steady State (Css-avg): Part A and C | 1065.435 Nanogram/milliliter | Geometric Coefficient of Variation 19.9 |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Average Observed Plasma Concentration at Steady State (Css-avg): Part A and C | 2256.793 Nanogram/milliliter | Geometric Coefficient of Variation 30.2 |
Secondary
Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C
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.
Time frame: Baseline (Day 1) up to Day 24
Population: All Treated Subjects Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A-Group 1: BMS-955176 (5 mg) | 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 |
| Part A-Group 1: BMS-955176 (5 mg) | 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 |
| Part A-Group 2: BMS-955176 (10 mg) | Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C | CD4+ | 14.6 Cells/microliter | Standard Deviation 120.82 |
| Part A-Group 2: BMS-955176 (10 mg) | Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C | CD8+ | -8.3 Cells/microliter | Standard Deviation 236.48 |
| Part A-Group 3: BMS-955176 (20 mg) | Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C | CD4+ | -70.1 Cells/microliter | Standard Deviation 68.49 |
| Part A-Group 3: BMS-955176 (20 mg) | Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C | CD8+ | -107.4 Cells/microliter | Standard Deviation 264.26 |
| Part A-Group 4: BMS-955176 (40 mg) | Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C | CD4+ | -23.6 Cells/microliter | Standard Deviation 42.13 |
| Part A-Group 4: BMS-955176 (40 mg) | Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C | CD8+ | -57.3 Cells/microliter | Standard Deviation 126.25 |
| Part A-Group 9: BMS-955176 (80 mg) | Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C | CD8+ | -194.6 Cells/microliter | Standard Deviation 182.3 |
| Part A-Group 9: BMS-955176 (80 mg) | Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C | CD4+ | -43.8 Cells/microliter | Standard Deviation 69.5 |
| Part A-Group 10: BMS-955176 (120 mg) | Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C | CD8+ | -161.3 Cells/microliter | Standard Deviation 203.01 |
| Part A-Group 10: BMS-955176 (120 mg) | Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C | CD4+ | -56.7 Cells/microliter | Standard Deviation 78.26 |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C | CD8+ | -214.4 Cells/microliter | Standard Deviation 390.13 |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C | CD4+ | -53.7 Cells/microliter | Standard Deviation 93.76 |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C | CD4+ | 24.5 Cells/microliter | Standard Deviation 57.58 |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C | CD8+ | -155.8 Cells/microliter | Standard Deviation 56.55 |
| Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C | CD4+ | -77.3 Cells/microliter | Standard Deviation 91.05 |
| Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C | CD8+ | -93.1 Cells/microliter | Standard Deviation 138.52 |
| Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C | CD4+ | 18 Cells/microliter | Standard Deviation 67.3 |
| Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C | CD8+ | -136.3 Cells/microliter | Standard Deviation 224.49 |
Secondary
Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part B
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.
Time frame: Baseline (Day 1) up to Day 42
Population: All Treated Subjects Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A-Group 1: BMS-955176 (5 mg) | Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part B | CD4+ | -133.2 Cells/microliter | Standard Deviation 84.14 |
| Part A-Group 1: BMS-955176 (5 mg) | Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part B | CD8+ | -442.8 Cells/microliter | Standard Deviation 243.99 |
| Part A-Group 2: BMS-955176 (10 mg) | Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part B | CD8+ | -466.1 Cells/microliter | Standard Deviation 491.21 |
| Part A-Group 2: BMS-955176 (10 mg) | Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part B | CD4+ | -106.4 Cells/microliter | Standard Deviation 166.59 |
| Part A-Group 3: BMS-955176 (20 mg) | Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part B | CD4+ | 33 Cells/microliter | Standard Deviation 144.79 |
| Part A-Group 3: BMS-955176 (20 mg) | Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part B | CD8+ | -216.3 Cells/microliter | Standard Deviation 287.06 |
| Part A-Group 4: BMS-955176 (40 mg) | Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part B | CD4+ | -89 Cells/microliter | Standard Deviation 35.71 |
| Part A-Group 4: BMS-955176 (40 mg) | Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part B | CD8+ | -147 Cells/microliter | Standard Deviation 140.67 |
Secondary
Degree of Fluctuation (DF): Part A and C
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).
Time frame: Baseline (Day 1) to Day 10
Population: Pharmacokinetic Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A-Group 1: BMS-955176 (5 mg) | Degree of Fluctuation (DF): Part A and C | 0.766 Ratio | Geometric Coefficient of Variation 29.4 |
| Part A-Group 2: BMS-955176 (10 mg) | Degree of Fluctuation (DF): Part A and C | 0.912 Ratio | Geometric Coefficient of Variation 15.2 |
| Part A-Group 3: BMS-955176 (20 mg) | Degree of Fluctuation (DF): Part A and C | 0.758 Ratio | Geometric Coefficient of Variation 20.2 |
| Part A-Group 4: BMS-955176 (40 mg) | Degree of Fluctuation (DF): Part A and C | 0.78 Ratio | Geometric Coefficient of Variation 22.1 |
| Part A-Group 9: BMS-955176 (80 mg) | Degree of Fluctuation (DF): Part A and C | 0.779 Ratio | Geometric Coefficient of Variation 28.5 |
| Part A-Group 10: BMS-955176 (120 mg) | Degree of Fluctuation (DF): Part A and C | 0.818 Ratio | Geometric Coefficient of Variation 17.1 |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Degree of Fluctuation (DF): Part A and C | 0.723 Ratio | Geometric Coefficient of Variation 13.7 |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Degree of Fluctuation (DF): Part A and C | 0.727 Ratio | Geometric Coefficient of Variation 24.5 |
Secondary
Maximum Decline From Baseline in Log10 HIV-1 RNA - Part A and C
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.
Time frame: Baseline (Day 1) up to Day 24
Population: All Treated Subjects Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A-Group 1: BMS-955176 (5 mg) | Maximum Decline From Baseline in Log10 HIV-1 RNA - Part A and C | -0.498 Log10 copies/mL |
| Part A-Group 2: BMS-955176 (10 mg) | Maximum Decline From Baseline in Log10 HIV-1 RNA - Part A and C | -0.976 Log10 copies/mL |
| Part A-Group 3: BMS-955176 (20 mg) | Maximum Decline From Baseline in Log10 HIV-1 RNA - Part A and C | -1.115 Log10 copies/mL |
| Part A-Group 4: BMS-955176 (40 mg) | Maximum Decline From Baseline in Log10 HIV-1 RNA - Part A and C | -1.701 Log10 copies/mL |
| Part A-Group 9: BMS-955176 (80 mg) | Maximum Decline From Baseline in Log10 HIV-1 RNA - Part A and C | -1.555 Log10 copies/mL |
| Part A-Group 10: BMS-955176 (120 mg) | Maximum Decline From Baseline in Log10 HIV-1 RNA - Part A and C | -1.654 Log10 copies/mL |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Maximum Decline From Baseline in Log10 HIV-1 RNA - Part A and C | -1.352 Log10 copies/mL |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Maximum Decline From Baseline in Log10 HIV-1 RNA - Part A and C | -1.257 Log10 copies/mL |
| Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | Maximum Decline From Baseline in Log10 HIV-1 RNA - Part A and C | -0.381 Log10 copies/mL |
| Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | Maximum Decline From Baseline in Log10 HIV-1 RNA - Part A and C | -0.419 Log10 copies/mL |
Secondary
Maximum Decline From Baseline in Log10 HIV-1 RNA - Part B
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.
Time frame: Baseline (Day 1) up to Day 42
Population: All Treated Subjects Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A-Group 1: BMS-955176 (5 mg) | Maximum Decline From Baseline in Log10 HIV-1 RNA - Part B | -1.858 Log10 copies/mL |
| Part A-Group 2: BMS-955176 (10 mg) | Maximum Decline From Baseline in Log10 HIV-1 RNA - Part B | -2.202 Log10 copies/mL |
| Part A-Group 3: BMS-955176 (20 mg) | Maximum Decline From Baseline in Log10 HIV-1 RNA - Part B | -2.39 Log10 copies/mL |
| Part A-Group 4: BMS-955176 (40 mg) | Maximum Decline From Baseline in Log10 HIV-1 RNA - Part B | -2.228 Log10 copies/mL |
Secondary
Maximum Observed Plasma Concentrations (Cmax) - Part A and C
Cmax was defined as the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Time frame: Pre-dose Day 1 and Day 10
Population: Pharmacokinetic Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A-Group 1: BMS-955176 (5 mg) | Maximum Observed Plasma Concentrations (Cmax) - Part A and C | Day 1 | 79.376 Nanogram/milliliter | Geometric Coefficient of Variation 37.6 |
| Part A-Group 1: BMS-955176 (5 mg) | Maximum Observed Plasma Concentrations (Cmax) - Part A and C | Day 10 | 170.778 Nanogram/milliliter | Geometric Coefficient of Variation 20.8 |
| Part A-Group 2: BMS-955176 (10 mg) | Maximum Observed Plasma Concentrations (Cmax) - Part A and C | Day 1 | 201.498 Nanogram/milliliter | Geometric Coefficient of Variation 21.1 |
| Part A-Group 2: BMS-955176 (10 mg) | Maximum Observed Plasma Concentrations (Cmax) - Part A and C | Day 10 | 337.379 Nanogram/milliliter | Geometric Coefficient of Variation 20.9 |
| Part A-Group 3: BMS-955176 (20 mg) | Maximum Observed Plasma Concentrations (Cmax) - Part A and C | Day 1 | 349.466 Nanogram/milliliter | Geometric Coefficient of Variation 23.2 |
| Part A-Group 3: BMS-955176 (20 mg) | Maximum Observed Plasma Concentrations (Cmax) - Part A and C | Day 10 | 705.073 Nanogram/milliliter | Geometric Coefficient of Variation 15.4 |
| Part A-Group 4: BMS-955176 (40 mg) | Maximum Observed Plasma Concentrations (Cmax) - Part A and C | Day 1 | 791.317 Nanogram/milliliter | Geometric Coefficient of Variation 46.8 |
| Part A-Group 4: BMS-955176 (40 mg) | Maximum Observed Plasma Concentrations (Cmax) - Part A and C | Day 10 | 1476.166 Nanogram/milliliter | Geometric Coefficient of Variation 17.2 |
| Part A-Group 9: BMS-955176 (80 mg) | Maximum Observed Plasma Concentrations (Cmax) - Part A and C | Day 1 | 1155.448 Nanogram/milliliter | Geometric Coefficient of Variation 27.1 |
| Part A-Group 9: BMS-955176 (80 mg) | Maximum Observed Plasma Concentrations (Cmax) - Part A and C | Day 10 | 2466.447 Nanogram/milliliter | Geometric Coefficient of Variation 22.1 |
| Part A-Group 10: BMS-955176 (120 mg) | Maximum Observed Plasma Concentrations (Cmax) - Part A and C | Day 1 | 1515.389 Nanogram/milliliter | Geometric Coefficient of Variation 27.4 |
| Part A-Group 10: BMS-955176 (120 mg) | Maximum Observed Plasma Concentrations (Cmax) - Part A and C | Day 10 | 2809.671 Nanogram/milliliter | Geometric Coefficient of Variation 25.5 |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Maximum Observed Plasma Concentrations (Cmax) - Part A and C | Day 10 | 1560.122 Nanogram/milliliter | Geometric Coefficient of Variation 17.4 |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Maximum Observed Plasma Concentrations (Cmax) - Part A and C | Day 1 | 793.569 Nanogram/milliliter | Geometric Coefficient of Variation 21.2 |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Maximum Observed Plasma Concentrations (Cmax) - Part A and C | Day 1 | 1907.747 Nanogram/milliliter | Geometric Coefficient of Variation 38.9 |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Maximum Observed Plasma Concentrations (Cmax) - Part A and C | Day 10 | 3377.967 Nanogram/milliliter | Geometric Coefficient of Variation 32.8 |
Secondary
Maximum Observed Plasma Concentrations (Cmax) - Part B
Cmax was defined as the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Time frame: Pre-dose Day 1 and Day 28
Population: Pharmacokinetic Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A-Group 1: BMS-955176 (5 mg) | Maximum Observed Plasma Concentrations (Cmax) - Part B | Day 1 | 695.596 Nanogram/milliliter | Geometric Coefficient of Variation 9.52 |
| Part A-Group 1: BMS-955176 (5 mg) | Maximum Observed Plasma Concentrations (Cmax) - Part B | Day 28 | 1667.817 Nanogram/milliliter | Geometric Coefficient of Variation 30.2 |
| Part A-Group 2: BMS-955176 (10 mg) | Maximum Observed Plasma Concentrations (Cmax) - Part B | Day 1 | 770.975 Nanogram/milliliter | Geometric Coefficient of Variation 28.2 |
| Part A-Group 2: BMS-955176 (10 mg) | Maximum Observed Plasma Concentrations (Cmax) - Part B | Day 28 | 1852 Nanogram/milliliter | Geometric Coefficient of Variation 33.6 |
| Part A-Group 3: BMS-955176 (20 mg) | Maximum Observed Plasma Concentrations (Cmax) - Part B | Day 1 | 1493.336 Nanogram/milliliter | Geometric Coefficient of Variation 24 |
| Part A-Group 3: BMS-955176 (20 mg) | Maximum Observed Plasma Concentrations (Cmax) - Part B | Day 28 | 3159.181 Nanogram/milliliter | Geometric Coefficient of Variation 22.1 |
Secondary
Number of Participants With Abnormal Changes in Physical Examination
Participants with abnormal changes in physical examination is presented.
Time frame: Day 1 to end of the study (Day 42)
Population: All Treated Subjects Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A-Group 1: BMS-955176 (5 mg) | Number of Participants With Abnormal Changes in Physical Examination | Height | 0 Participants |
| Part A-Group 1: BMS-955176 (5 mg) | Number of Participants With Abnormal Changes in Physical Examination | Body mass index | 0 Participants |
| Part A-Group 1: BMS-955176 (5 mg) | Number of Participants With Abnormal Changes in Physical Examination | Weight | 0 Participants |
| Part A-Group 2: BMS-955176 (10 mg) | Number of Participants With Abnormal Changes in Physical Examination | Body mass index | 0 Participants |
| Part A-Group 2: BMS-955176 (10 mg) | Number of Participants With Abnormal Changes in Physical Examination | Height | 0 Participants |
| Part A-Group 2: BMS-955176 (10 mg) | Number of Participants With Abnormal Changes in Physical Examination | Weight | 0 Participants |
| Part A-Group 3: BMS-955176 (20 mg) | Number of Participants With Abnormal Changes in Physical Examination | Body mass index | 0 Participants |
| Part A-Group 3: BMS-955176 (20 mg) | Number of Participants With Abnormal Changes in Physical Examination | Weight | 0 Participants |
| Part A-Group 3: BMS-955176 (20 mg) | Number of Participants With Abnormal Changes in Physical Examination | Height | 0 Participants |
| Part A-Group 4: BMS-955176 (40 mg) | Number of Participants With Abnormal Changes in Physical Examination | Height | 0 Participants |
| Part A-Group 4: BMS-955176 (40 mg) | Number of Participants With Abnormal Changes in Physical Examination | Weight | 0 Participants |
| Part A-Group 4: BMS-955176 (40 mg) | Number of Participants With Abnormal Changes in Physical Examination | Body mass index | 0 Participants |
| Part A-Group 9: BMS-955176 (80 mg) | Number of Participants With Abnormal Changes in Physical Examination | Height | 0 Participants |
| Part A-Group 9: BMS-955176 (80 mg) | Number of Participants With Abnormal Changes in Physical Examination | Weight | 0 Participants |
| Part A-Group 9: BMS-955176 (80 mg) | Number of Participants With Abnormal Changes in Physical Examination | Body mass index | 0 Participants |
| Part A-Group 10: BMS-955176 (120 mg) | Number of Participants With Abnormal Changes in Physical Examination | Body mass index | 0 Participants |
| Part A-Group 10: BMS-955176 (120 mg) | Number of Participants With Abnormal Changes in Physical Examination | Height | 0 Participants |
| Part A-Group 10: BMS-955176 (120 mg) | Number of Participants With Abnormal Changes in Physical Examination | Weight | 0 Participants |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Number of Participants With Abnormal Changes in Physical Examination | Height | 0 Participants |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Number of Participants With Abnormal Changes in Physical Examination | Weight | 0 Participants |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Number of Participants With Abnormal Changes in Physical Examination | Body mass index | 0 Participants |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Number of Participants With Abnormal Changes in Physical Examination | Weight | 0 Participants |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Number of Participants With Abnormal Changes in Physical Examination | Height | 0 Participants |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Number of Participants With Abnormal Changes in Physical Examination | Body mass index | 0 Participants |
| Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | Number of Participants With Abnormal Changes in Physical Examination | Weight | 0 Participants |
| Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | Number of Participants With Abnormal Changes in Physical Examination | Body mass index | 0 Participants |
| Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | Number of Participants With Abnormal Changes in Physical Examination | Height | 0 Participants |
| Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | Number of Participants With Abnormal Changes in Physical Examination | Weight | 0 Participants |
| Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | Number of Participants With Abnormal Changes in Physical Examination | Height | 0 Participants |
| Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | Number of Participants With Abnormal Changes in Physical Examination | Body mass index | 0 Participants |
| Part C-Group 8: BMS-955176 (40 mg) | Number of Participants With Abnormal Changes in Physical Examination | Weight | 0 Participants |
| Part C-Group 8: BMS-955176 (40 mg) | Number of Participants With Abnormal Changes in Physical Examination | Body mass index | 0 Participants |
| Part C-Group 8: BMS-955176 (40 mg) | Number of Participants With Abnormal Changes in Physical Examination | Height | 0 Participants |
| Part C-Group 13: BMS-955176 (120 mg) | Number of Participants With Abnormal Changes in Physical Examination | Weight | 0 Participants |
| Part C-Group 13: BMS-955176 (120 mg) | Number of Participants With Abnormal Changes in Physical Examination | Height | 0 Participants |
| Part C-Group 13: BMS-955176 (120 mg) | Number of Participants With Abnormal Changes in Physical Examination | Body mass index | 0 Participants |
| Placebo Clade B | Number of Participants With Abnormal Changes in Physical Examination | Height | 0 Participants |
| Placebo Clade B | Number of Participants With Abnormal Changes in Physical Examination | Body mass index | 0 Participants |
| Placebo Clade B | Number of Participants With Abnormal Changes in Physical Examination | Weight | 0 Participants |
| Placebo Clade C | Number of Participants With Abnormal Changes in Physical Examination | Body mass index | 0 Participants |
| Placebo Clade C | Number of Participants With Abnormal Changes in Physical Examination | Weight | 0 Participants |
| Placebo Clade C | Number of Participants With Abnormal Changes in Physical Examination | Height | 0 Participants |
Secondary
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
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.
Time frame: Day 1 to end of the study (Day 42)
Population: All Treated Subjects Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A-Group 1: BMS-955176 (5 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | PR > 200 msec | 1 Participants |
| Part A-Group 1: BMS-955176 (5 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QT > 500 msec | 0 Participants |
| Part A-Group 1: BMS-955176 (5 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QRS > 120 msec | 0 Participants |
| Part A-Group 1: BMS-955176 (5 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QTcF > 450 msec | 0 Participants |
| Part A-Group 1: BMS-955176 (5 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QTcB > 450 msec | 0 Participants |
| Part A-Group 2: BMS-955176 (10 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | PR > 200 msec | 1 Participants |
| Part A-Group 2: BMS-955176 (10 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QTcB > 450 msec | 0 Participants |
| Part A-Group 2: BMS-955176 (10 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QT > 500 msec | 0 Participants |
| Part A-Group 2: BMS-955176 (10 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QRS > 120 msec | 0 Participants |
| Part A-Group 2: BMS-955176 (10 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QTcF > 450 msec | 0 Participants |
| Part A-Group 3: BMS-955176 (20 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | PR > 200 msec | 1 Participants |
| Part A-Group 3: BMS-955176 (20 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QT > 500 msec | 0 Participants |
| Part A-Group 3: BMS-955176 (20 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QTcF > 450 msec | 1 Participants |
| Part A-Group 3: BMS-955176 (20 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QRS > 120 msec | 0 Participants |
| Part A-Group 3: BMS-955176 (20 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QTcB > 450 msec | 0 Participants |
| Part A-Group 4: BMS-955176 (40 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QRS > 120 msec | 0 Participants |
| Part A-Group 4: BMS-955176 (40 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | PR > 200 msec | 0 Participants |
| Part A-Group 4: BMS-955176 (40 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QTcF > 450 msec | 0 Participants |
| Part A-Group 4: BMS-955176 (40 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QTcB > 450 msec | 0 Participants |
| Part A-Group 4: BMS-955176 (40 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QT > 500 msec | 0 Participants |
| Part A-Group 9: BMS-955176 (80 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | PR > 200 msec | 0 Participants |
| Part A-Group 9: BMS-955176 (80 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QT > 500 msec | 0 Participants |
| Part A-Group 9: BMS-955176 (80 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QRS > 120 msec | 0 Participants |
| Part A-Group 9: BMS-955176 (80 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QTcB > 450 msec | 0 Participants |
| Part A-Group 9: BMS-955176 (80 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QTcF > 450 msec | 0 Participants |
| Part A-Group 10: BMS-955176 (120 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | PR > 200 msec | 2 Participants |
| Part A-Group 10: BMS-955176 (120 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QTcB > 450 msec | 0 Participants |
| Part A-Group 10: BMS-955176 (120 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QT > 500 msec | 0 Participants |
| Part A-Group 10: BMS-955176 (120 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QTcF > 450 msec | 0 Participants |
| Part A-Group 10: BMS-955176 (120 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QRS > 120 msec | 0 Participants |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QTcF > 450 msec | 0 Participants |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QTcB > 450 msec | 0 Participants |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QRS > 120 msec | 1 Participants |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | PR > 200 msec | 0 Participants |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QT > 500 msec | 0 Participants |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QT > 500 msec | 0 Participants |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | PR > 200 msec | 1 Participants |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QRS > 120 msec | 0 Participants |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QTcB > 450 msec | 0 Participants |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QTcF > 450 msec | 0 Participants |
| Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QTcB > 450 msec | 0 Participants |
| Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | PR > 200 msec | 1 Participants |
| Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QTcF > 450 msec | 0 Participants |
| Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QRS > 120 msec | 0 Participants |
| Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QT > 500 msec | 0 Participants |
| Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QRS > 120 msec | 0 Participants |
| Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QTcB > 450 msec | 0 Participants |
| Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QT > 500 msec | 0 Participants |
| Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QTcF > 450 msec | 0 Participants |
| Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | PR > 200 msec | 1 Participants |
| Part C-Group 8: BMS-955176 (40 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | PR > 200 msec | 1 Participants |
| Part C-Group 8: BMS-955176 (40 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QRS > 120 msec | 0 Participants |
| Part C-Group 8: BMS-955176 (40 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QTcB > 450 msec | 0 Participants |
| Part C-Group 8: BMS-955176 (40 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QTcF > 450 msec | 0 Participants |
| Part C-Group 8: BMS-955176 (40 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QT > 500 msec | 0 Participants |
| Part C-Group 13: BMS-955176 (120 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QTcF > 450 msec | 0 Participants |
| Part C-Group 13: BMS-955176 (120 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QT > 500 msec | 0 Participants |
| Part C-Group 13: BMS-955176 (120 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | PR > 200 msec | 0 Participants |
| Part C-Group 13: BMS-955176 (120 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QTcB > 450 msec | 0 Participants |
| Part C-Group 13: BMS-955176 (120 mg) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QRS > 120 msec | 0 Participants |
| Placebo Clade B | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QT > 500 msec | 0 Participants |
| Placebo Clade B | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QRS > 120 msec | 0 Participants |
| Placebo Clade B | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QTcF > 450 msec | 0 Participants |
| Placebo Clade B | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QTcB > 450 msec | 0 Participants |
| Placebo Clade B | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | PR > 200 msec | 0 Participants |
| Placebo Clade C | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QTcF > 450 msec | 0 Participants |
| Placebo Clade C | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | PR > 200 msec | 0 Participants |
| Placebo Clade C | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QTcB > 450 msec | 1 Participants |
| Placebo Clade C | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QRS > 120 msec | 0 Participants |
| Placebo Clade C | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | QT > 500 msec | 0 Participants |
Secondary
Number of Participants With Clinically Significant Changes in Heart Rate
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.
Time frame: Day 1 to end of the study (Day 42)
Population: All Treated Subjects Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A-Group 1: BMS-955176 (5 mg) | Number of Participants With Clinically Significant Changes in Heart Rate | 0 Participants |
| Part A-Group 2: BMS-955176 (10 mg) | Number of Participants With Clinically Significant Changes in Heart Rate | 0 Participants |
| Part A-Group 3: BMS-955176 (20 mg) | Number of Participants With Clinically Significant Changes in Heart Rate | 0 Participants |
| Part A-Group 4: BMS-955176 (40 mg) | Number of Participants With Clinically Significant Changes in Heart Rate | 0 Participants |
| Part A-Group 9: BMS-955176 (80 mg) | Number of Participants With Clinically Significant Changes in Heart Rate | 0 Participants |
| Part A-Group 10: BMS-955176 (120 mg) | Number of Participants With Clinically Significant Changes in Heart Rate | 0 Participants |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Number of Participants With Clinically Significant Changes in Heart Rate | 0 Participants |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Number of Participants With Clinically Significant Changes in Heart Rate | 0 Participants |
| Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | Number of Participants With Clinically Significant Changes in Heart Rate | 1 Participants |
| Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | Number of Participants With Clinically Significant Changes in Heart Rate | 0 Participants |
| Part C-Group 8: BMS-955176 (40 mg) | Number of Participants With Clinically Significant Changes in Heart Rate | 0 Participants |
| Part C-Group 13: BMS-955176 (120 mg) | Number of Participants With Clinically Significant Changes in Heart Rate | 2 Participants |
| Placebo Clade B | Number of Participants With Clinically Significant Changes in Heart Rate | 1 Participants |
| Placebo Clade C | Number of Participants With Clinically Significant Changes in Heart Rate | 0 Participants |
Secondary
Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
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.
Time frame: Day 1 to end of the study (Day 42)
Population: All Treated Subjects Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A-Group 1: BMS-955176 (5 mg) | Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP | 0 Participants |
| Part A-Group 1: BMS-955176 (5 mg) | Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP | 0 Participants |
| Part A-Group 2: BMS-955176 (10 mg) | Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP | 0 Participants |
| Part A-Group 2: BMS-955176 (10 mg) | Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP | 1 Participants |
| Part A-Group 3: BMS-955176 (20 mg) | Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP | 0 Participants |
| Part A-Group 3: BMS-955176 (20 mg) | Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP | 1 Participants |
| Part A-Group 4: BMS-955176 (40 mg) | Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP | 0 Participants |
| Part A-Group 4: BMS-955176 (40 mg) | Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP | 0 Participants |
| Part A-Group 9: BMS-955176 (80 mg) | Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP | 0 Participants |
| Part A-Group 9: BMS-955176 (80 mg) | Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP | 0 Participants |
| Part A-Group 10: BMS-955176 (120 mg) | Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP | 0 Participants |
| Part A-Group 10: BMS-955176 (120 mg) | Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP | 0 Participants |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP | 0 Participants |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP | 0 Participants |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP | 1 Participants |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP | 1 Participants |
| Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP | 0 Participants |
| Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP | 0 Participants |
| Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP | 1 Participants |
| Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP | 0 Participants |
| Part C-Group 8: BMS-955176 (40 mg) | Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP | 1 Participants |
| Part C-Group 8: BMS-955176 (40 mg) | Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP | 0 Participants |
| Part C-Group 13: BMS-955176 (120 mg) | Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP | 0 Participants |
| Part C-Group 13: BMS-955176 (120 mg) | Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP | 0 Participants |
| Placebo Clade B | Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP | 0 Participants |
| Placebo Clade B | Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP | 1 Participants |
| Placebo Clade C | Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP | 0 Participants |
| Placebo Clade C | Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP | 0 Participants |
Secondary
Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline
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.
Time frame: Day 1 to up to end of the study (Day 42)
Population: All Treated Subjects Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A-Group 1: BMS-955176 (5 mg) | Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline | Neutrophils (Absolute) | 0 Participants |
| Part A-Group 1: BMS-955176 (5 mg) | Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline | Bilirubin (Total) | 0 Participants |
| Part A-Group 2: BMS-955176 (10 mg) | Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline | Neutrophils (Absolute) | 0 Participants |
| Part A-Group 2: BMS-955176 (10 mg) | Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline | Bilirubin (Total) | 0 Participants |
| Part A-Group 3: BMS-955176 (20 mg) | Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline | Neutrophils (Absolute) | 0 Participants |
| Part A-Group 3: BMS-955176 (20 mg) | Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline | Bilirubin (Total) | 0 Participants |
| Part A-Group 4: BMS-955176 (40 mg) | Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline | Neutrophils (Absolute) | 0 Participants |
| Part A-Group 4: BMS-955176 (40 mg) | Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline | Bilirubin (Total) | 0 Participants |
| Part A-Group 9: BMS-955176 (80 mg) | Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline | Bilirubin (Total) | 0 Participants |
| Part A-Group 9: BMS-955176 (80 mg) | Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline | Neutrophils (Absolute) | 0 Participants |
| Part A-Group 10: BMS-955176 (120 mg) | Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline | Bilirubin (Total) | 0 Participants |
| Part A-Group 10: BMS-955176 (120 mg) | Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline | Neutrophils (Absolute) | 1 Participants |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline | Neutrophils (Absolute) | 0 Participants |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline | Bilirubin (Total) | 2 Participants |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline | Neutrophils (Absolute) | 0 Participants |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline | Bilirubin (Total) | 5 Participants |
| Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline | Bilirubin (Total) | 3 Participants |
| Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline | Neutrophils (Absolute) | 0 Participants |
| Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline | Bilirubin (Total) | 0 Participants |
| Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline | Neutrophils (Absolute) | 1 Participants |
| Part C-Group 8: BMS-955176 (40 mg) | Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline | Bilirubin (Total) | 0 Participants |
| Part C-Group 8: BMS-955176 (40 mg) | Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline | Neutrophils (Absolute) | 0 Participants |
| Part C-Group 13: BMS-955176 (120 mg) | Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline | Bilirubin (Total) | 0 Participants |
| Part C-Group 13: BMS-955176 (120 mg) | Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline | Neutrophils (Absolute) | 0 Participants |
| Placebo Clade B | Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline | Neutrophils (Absolute) | 0 Participants |
| Placebo Clade B | Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline | Bilirubin (Total) | 0 Participants |
| Placebo Clade C | Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline | Bilirubin (Total) | 0 Participants |
| Placebo Clade C | Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline | Neutrophils (Absolute) | 0 Participants |
Secondary
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
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.
Time frame: Day 1 to end of the study (Day 42)
Population: All Treated Subjects Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A-Group 1: BMS-955176 (5 mg) | 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 |
| Part A-Group 1: BMS-955176 (5 mg) | 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 |
| Part A-Group 1: BMS-955176 (5 mg) | 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 |
| Part A-Group 1: BMS-955176 (5 mg) | 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 |
| Part A-Group 1: BMS-955176 (5 mg) | 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 |
| Part A-Group 1: BMS-955176 (5 mg) | 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 |
| Part A-Group 2: BMS-955176 (10 mg) | 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 |
| Part A-Group 2: BMS-955176 (10 mg) | 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 |
| Part A-Group 2: BMS-955176 (10 mg) | 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 |
| Part A-Group 2: BMS-955176 (10 mg) | 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 |
| Part A-Group 2: BMS-955176 (10 mg) | 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 |
| Part A-Group 2: BMS-955176 (10 mg) | 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 |
| Part A-Group 3: BMS-955176 (20 mg) | 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 |
| Part A-Group 3: BMS-955176 (20 mg) | 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 |
| Part A-Group 3: BMS-955176 (20 mg) | 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 |
| Part A-Group 3: BMS-955176 (20 mg) | 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 |
| Part A-Group 3: BMS-955176 (20 mg) | 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 |
| Part A-Group 3: BMS-955176 (20 mg) | 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 |
| Part A-Group 4: BMS-955176 (40 mg) | 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 |
| Part A-Group 4: BMS-955176 (40 mg) | 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 |
| Part A-Group 4: BMS-955176 (40 mg) | 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 | 6 Participants |
| Part A-Group 4: BMS-955176 (40 mg) | 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 |
| Part A-Group 4: BMS-955176 (40 mg) | 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 |
| Part A-Group 4: BMS-955176 (40 mg) | 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 |
| Part A-Group 9: BMS-955176 (80 mg) | 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 |
| Part A-Group 9: BMS-955176 (80 mg) | 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 |
| Part A-Group 9: BMS-955176 (80 mg) | 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 |
| Part A-Group 9: BMS-955176 (80 mg) | 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 |
| Part A-Group 9: BMS-955176 (80 mg) | 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 | 8 Participants |
| Part A-Group 9: BMS-955176 (80 mg) | 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 |
| Part A-Group 10: BMS-955176 (120 mg) | 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 | 7 Participants |
| Part A-Group 10: BMS-955176 (120 mg) | 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 |
| Part A-Group 10: BMS-955176 (120 mg) | 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 |
| Part A-Group 10: BMS-955176 (120 mg) | 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 |
| Part A-Group 10: BMS-955176 (120 mg) | 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 |
| Part A-Group 10: BMS-955176 (120 mg) | 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 |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | 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 |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | 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 |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | 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 |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | 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 |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | 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 |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | 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 | 8 Participants |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | 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 |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | 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 |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | 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 |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | 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 | 8 Participants |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | 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 |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | 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 |
| Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | 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 |
| Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | 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 |
| Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | 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 |
| Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | 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 |
| Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | 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 | 4 Participants |
| Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | 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 |
| Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | 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 |
| Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | 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 |
| Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | 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 |
| Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | 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 |
| Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | 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 |
| Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | 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 | 6 Participants |
| Part C-Group 8: BMS-955176 (40 mg) | 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 |
| Part C-Group 8: BMS-955176 (40 mg) | 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 | 7 Participants |
| Part C-Group 8: BMS-955176 (40 mg) | 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 |
| Part C-Group 8: BMS-955176 (40 mg) | 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 |
| Part C-Group 8: BMS-955176 (40 mg) | 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 |
| Part C-Group 8: BMS-955176 (40 mg) | 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 |
| Part C-Group 13: BMS-955176 (120 mg) | 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 |
| Part C-Group 13: BMS-955176 (120 mg) | 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 |
| Part C-Group 13: BMS-955176 (120 mg) | 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 |
| Part C-Group 13: BMS-955176 (120 mg) | 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 |
| Part C-Group 13: BMS-955176 (120 mg) | 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 | 6 Participants |
| Part C-Group 13: BMS-955176 (120 mg) | 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 |
| Placebo Clade B | 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 |
| Placebo Clade B | 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 |
| Placebo Clade B | 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 | 9 Participants |
| Placebo Clade B | 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 |
| Placebo Clade B | 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 |
| Placebo Clade B | 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 |
| Placebo Clade C | 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 |
| Placebo Clade C | 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 |
| Placebo Clade C | 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 | 3 Participants |
| Placebo Clade C | 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 |
| Placebo Clade C | 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 |
| Placebo Clade C | 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 |
Secondary
Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C
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.
Time frame: Baseline (Day 1) up to Day 24
Population: All Treated Subjects Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A-Group 1: BMS-955176 (5 mg) | 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 |
| Part A-Group 1: BMS-955176 (5 mg) | 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 |
| Part A-Group 2: BMS-955176 (10 mg) | Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C | CD4+ | 0.29 Percent change | Standard Deviation 2.215 |
| Part A-Group 2: BMS-955176 (10 mg) | Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C | CD8+ | 0.43 Percent change | Standard Deviation 3.207 |
| Part A-Group 3: BMS-955176 (20 mg) | Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C | CD4+ | -1.29 Percent change | Standard Deviation 5.057 |
| Part A-Group 3: BMS-955176 (20 mg) | Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C | CD8+ | 0 Percent change | Standard Deviation 6.325 |
| Part A-Group 4: BMS-955176 (40 mg) | Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C | CD4+ | 0.86 Percent change | Standard Deviation 3.288 |
| Part A-Group 4: BMS-955176 (40 mg) | Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C | CD8+ | 1 Percent change | Standard Deviation 3.225 |
| Part A-Group 9: BMS-955176 (80 mg) | Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C | CD8+ | -0.25 Percent change | Standard Deviation 5.064 |
| Part A-Group 9: BMS-955176 (80 mg) | Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C | CD4+ | 2.13 Percent change | Standard Deviation 3.399 |
| Part A-Group 10: BMS-955176 (120 mg) | Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C | CD8+ | -2.29 Percent change | Standard Deviation 2.812 |
| Part A-Group 10: BMS-955176 (120 mg) | Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C | CD4+ | 0.29 Percent change | Standard Deviation 2.87 |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C | CD8+ | 0 Percent change | Standard Deviation 1.871 |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C | CD4+ | 0.5 Percent change | Standard Deviation 3.017 |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C | CD4+ | 3.17 Percent change | Standard Deviation 3.371 |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C | CD8+ | -4.25 Percent change | Standard Deviation 3.775 |
| Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C | CD4+ | -0.22 Percent change | Standard Deviation 3.93 |
| Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C | CD8+ | 1.75 Percent change | Standard Deviation 4.2 |
| Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C | CD4+ | 2.75 Percent change | Standard Deviation 3.775 |
| Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C | CD8+ | -1.33 Percent change | Standard Deviation 5.132 |
Secondary
Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part B
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.
Time frame: Baseline (Day 1) up to Day 42
Population: All Treated Subjects Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A-Group 1: BMS-955176 (5 mg) | 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 |
| Part A-Group 1: BMS-955176 (5 mg) | 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 |
| Part A-Group 2: BMS-955176 (10 mg) | Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part B | CD8+ | -6.25 Percent change | Standard Deviation 4.464 |
| Part A-Group 2: BMS-955176 (10 mg) | Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part B | CD4+ | 3.25 Percent change | Standard Deviation 3.105 |
| Part A-Group 3: BMS-955176 (20 mg) | Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part B | CD4+ | 4.75 Percent change | Standard Deviation 2.217 |
| Part A-Group 3: BMS-955176 (20 mg) | Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part B | CD8+ | -3.75 Percent change | Standard Deviation 2.062 |
| Part A-Group 4: BMS-955176 (40 mg) | Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part B | CD4+ | -0.75 Percent change | Standard Deviation 1.893 |
| Part A-Group 4: BMS-955176 (40 mg) | Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part B | CD8+ | -1.25 Percent change | Standard Deviation 2.217 |
Secondary
Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C
C24 was defined as the plasma concentration of BMS-955176 at 24 hours post-dose.
Time frame: 24 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A-Group 1: BMS-955176 (5 mg) | Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C | Day 1 | 34.946 Nanogram/milliliter | Geometric Coefficient of Variation 28.4 |
| Part A-Group 1: BMS-955176 (5 mg) | Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C | Day 10 | 81.642 Nanogram/milliliter | Geometric Coefficient of Variation 23.1 |
| Part A-Group 2: BMS-955176 (10 mg) | Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C | Day 1 | 79.002 Nanogram/milliliter | Geometric Coefficient of Variation 27.2 |
| Part A-Group 2: BMS-955176 (10 mg) | Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C | Day 10 | 138.775 Nanogram/milliliter | Geometric Coefficient of Variation 34.1 |
| Part A-Group 3: BMS-955176 (20 mg) | Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C | Day 1 | 154.5 Nanogram/milliliter | Geometric Coefficient of Variation 23.7 |
| Part A-Group 3: BMS-955176 (20 mg) | Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C | Day 10 | 325.934 Nanogram/milliliter | Geometric Coefficient of Variation 19.4 |
| Part A-Group 4: BMS-955176 (40 mg) | Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C | Day 1 | 286.268 Nanogram/milliliter | Geometric Coefficient of Variation 15.6 |
| Part A-Group 4: BMS-955176 (40 mg) | Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C | Day 10 | 713.077 Nanogram/milliliter | Geometric Coefficient of Variation 21.9 |
| Part A-Group 9: BMS-955176 (80 mg) | Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C | Day 1 | 482.349 Nanogram/milliliter | Geometric Coefficient of Variation 34.3 |
| Part A-Group 9: BMS-955176 (80 mg) | Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C | Day 10 | 1150.397 Nanogram/milliliter | Geometric Coefficient of Variation 31.5 |
| Part A-Group 10: BMS-955176 (120 mg) | Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C | Day 1 | 624.745 Nanogram/milliliter | Geometric Coefficient of Variation 24.6 |
| Part A-Group 10: BMS-955176 (120 mg) | Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C | Day 10 | 1288.985 Nanogram/milliliter | Geometric Coefficient of Variation 26.8 |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C | Day 10 | 779.438 Nanogram/milliliter | Geometric Coefficient of Variation 24.6 |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C | Day 1 | 339.173 Nanogram/milliliter | Geometric Coefficient of Variation 30.1 |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C | Day 1 | 865.867 Nanogram/milliliter | Geometric Coefficient of Variation 41 |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C | Day 10 | 1691.306 Nanogram/milliliter | Geometric Coefficient of Variation 29 |
Secondary
Plasma Concentration 24 Hours Post-Dose (C24) - Part B
C24 was defined as the plasma concentration of BMS-955176 at 24 hours post-dose.
Time frame: 24 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A-Group 1: BMS-955176 (5 mg) | Plasma Concentration 24 Hours Post-Dose (C24) - Part B | Day 1 | 462.312 Nanogram/milliliter | Geometric Coefficient of Variation 25 |
| Part A-Group 1: BMS-955176 (5 mg) | Plasma Concentration 24 Hours Post-Dose (C24) - Part B | Day 28 | 1099.313 Nanogram/milliliter | Geometric Coefficient of Variation 37 |
| Part A-Group 2: BMS-955176 (10 mg) | Plasma Concentration 24 Hours Post-Dose (C24) - Part B | Day 1 | 520.048 Nanogram/milliliter | Geometric Coefficient of Variation 27.7 |
| Part A-Group 2: BMS-955176 (10 mg) | Plasma Concentration 24 Hours Post-Dose (C24) - Part B | Day 28 | 1163.177 Nanogram/milliliter | Geometric Coefficient of Variation 30.9 |
| Part A-Group 3: BMS-955176 (20 mg) | Plasma Concentration 24 Hours Post-Dose (C24) - Part B | Day 1 | 899.364 Nanogram/milliliter | Geometric Coefficient of Variation 21.2 |
| Part A-Group 3: BMS-955176 (20 mg) | Plasma Concentration 24 Hours Post-Dose (C24) - Part B | Day 28 | 2010.679 Nanogram/milliliter | Geometric Coefficient of Variation 19.9 |
Secondary
Plasma Half-life: Part A and C
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).
Time frame: Baseline (Day 1) to Day 10
Population: Pharmacokinetic Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A-Group 1: BMS-955176 (5 mg) | Plasma Half-life: Part A and C | 32.134 Hours |
| Part A-Group 2: BMS-955176 (10 mg) | Plasma Half-life: Part A and C | 31.967 Hours |
| Part A-Group 3: BMS-955176 (20 mg) | Plasma Half-life: Part A and C | 27.382 Hours |
| Part A-Group 4: BMS-955176 (40 mg) | Plasma Half-life: Part A and C | 33.475 Hours |
| Part A-Group 9: BMS-955176 (80 mg) | Plasma Half-life: Part A and C | 29.171 Hours |
| Part A-Group 10: BMS-955176 (120 mg) | Plasma Half-life: Part A and C | 34.574 Hours |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Plasma Half-life: Part A and C | 31.565 Hours |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Plasma Half-life: Part A and C | 35.278 Hours |
Secondary
Time to Maximum Decline in Log 10 HIV-1 RNA - Part A and C
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.
Time frame: Baseline (Day 1) up to Day 24
Population: All Treated Subjects Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A-Group 1: BMS-955176 (5 mg) | Time to Maximum Decline in Log 10 HIV-1 RNA - Part A and C | 168 Hours |
| Part A-Group 2: BMS-955176 (10 mg) | Time to Maximum Decline in Log 10 HIV-1 RNA - Part A and C | 216 Hours |
| Part A-Group 3: BMS-955176 (20 mg) | Time to Maximum Decline in Log 10 HIV-1 RNA - Part A and C | 203.9 Hours |
| Part A-Group 4: BMS-955176 (40 mg) | Time to Maximum Decline in Log 10 HIV-1 RNA - Part A and C | 240.15 Hours |
| Part A-Group 9: BMS-955176 (80 mg) | Time to Maximum Decline in Log 10 HIV-1 RNA - Part A and C | 204 Hours |
| Part A-Group 10: BMS-955176 (120 mg) | Time to Maximum Decline in Log 10 HIV-1 RNA - Part A and C | 240.2 Hours |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Time to Maximum Decline in Log 10 HIV-1 RNA - Part A and C | 228.05 Hours |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Time to Maximum Decline in Log 10 HIV-1 RNA - Part A and C | 215.8 Hours |
| Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | Time to Maximum Decline in Log 10 HIV-1 RNA - Part A and C | 216.2 Hours |
| Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | Time to Maximum Decline in Log 10 HIV-1 RNA - Part A and C | 132.05 Hours |
Secondary
Time to Maximum Decline in Log 10 HIV-1 RNA - Part B
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.
Time frame: Baseline (Day 1) up to Day 42
Population: All Treated Subjects Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A-Group 1: BMS-955176 (5 mg) | Time to Maximum Decline in Log 10 HIV-1 RNA - Part B | 624 Hours |
| Part A-Group 2: BMS-955176 (10 mg) | Time to Maximum Decline in Log 10 HIV-1 RNA - Part B | 636.05 Hours |
| Part A-Group 3: BMS-955176 (20 mg) | Time to Maximum Decline in Log 10 HIV-1 RNA - Part B | 588 Hours |
| Part A-Group 4: BMS-955176 (40 mg) | Time to Maximum Decline in Log 10 HIV-1 RNA - Part B | 636.05 Hours |
Secondary
Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C
Time to reach the maximum plasma concentration was directly determined from concentration time data.
Time frame: Pre-dose Day 1 and Day 10
Population: Pharmacokinetic Population comprised of all participants who received any study medication and had any available concentration-time data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A-Group 1: BMS-955176 (5 mg) | Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C | Day 1 | 3 Hours |
| Part A-Group 1: BMS-955176 (5 mg) | Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C | Day 10 | 3 Hours |
| Part A-Group 2: BMS-955176 (10 mg) | Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C | Day 1 | 2.51 Hours |
| Part A-Group 2: BMS-955176 (10 mg) | Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C | Day 10 | 3 Hours |
| Part A-Group 3: BMS-955176 (20 mg) | Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C | Day 1 | 3 Hours |
| Part A-Group 3: BMS-955176 (20 mg) | Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C | Day 10 | 4 Hours |
| Part A-Group 4: BMS-955176 (40 mg) | Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C | Day 1 | 4 Hours |
| Part A-Group 4: BMS-955176 (40 mg) | Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C | Day 10 | 3 Hours |
| Part A-Group 9: BMS-955176 (80 mg) | Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C | Day 1 | 3.5 Hours |
| Part A-Group 9: BMS-955176 (80 mg) | Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C | Day 10 | 3 Hours |
| Part A-Group 10: BMS-955176 (120 mg) | Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C | Day 1 | 3 Hours |
| Part A-Group 10: BMS-955176 (120 mg) | Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C | Day 10 | 2.5 Hours |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C | Day 10 | 3 Hours |
| Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C | Day 1 | 3.5 Hours |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C | Day 1 | 3.53 Hours |
| Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C | Day 10 | 3 Hours |
Secondary
Time to Reach Maximum Plasma Concentration (Tmax) - Part B
Tmax was directly determined from concentration time data.
Time frame: Pre-dose Day 1 and Day 28
Population: Pharmacokinetic Population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A-Group 1: BMS-955176 (5 mg) | Time to Reach Maximum Plasma Concentration (Tmax) - Part B | Day 1 | 5.01 Hours |
| Part A-Group 1: BMS-955176 (5 mg) | Time to Reach Maximum Plasma Concentration (Tmax) - Part B | Day 28 | 4.5 Hours |
| Part A-Group 2: BMS-955176 (10 mg) | Time to Reach Maximum Plasma Concentration (Tmax) - Part B | Day 1 | 5.05 Hours |
| Part A-Group 2: BMS-955176 (10 mg) | Time to Reach Maximum Plasma Concentration (Tmax) - Part B | Day 28 | 5 Hours |
| Part A-Group 3: BMS-955176 (20 mg) | Time to Reach Maximum Plasma Concentration (Tmax) - Part B | Day 1 | 5 Hours |
| Part A-Group 3: BMS-955176 (20 mg) | Time to Reach Maximum Plasma Concentration (Tmax) - Part B | Day 28 | 4.5 Hours |