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BMS-955176

Phase 2

Infection, Human Immunodeficiency Virus | Small molecule | Other |GSK plc|Last Updated: Nov 25, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials4
Total Enrollment212
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01803074Study to Evaluate a HIV Drug for the Treatment of HIV InfectionPHASE2 COMPLETED 107 — — Apr 4, 2013Nov 29, 2014Nov 25, 20191 Germany
NCT02273947Food Effect Study With BMS-955176PHASE1 COMPLETED 12 — — Oct 23, 2014Aug 15, 2016Apr 17, 20171 United Kingdom
NCT02157467Study of Combined Oral Contraceptive Effects in Female SubjectsPHASE1 COMPLETED 46 — — Jun 2, 2014Aug 25, 2014Apr 17, 2018 - —
NCT02095886Relative Bioavailability Study With BMS-955176PHASE1 COMPLETED 47 — — Mar 25, 2014Jul 7, 2014Sep 11, 20171 United Kingdom
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Study Endpoints
Primary Endpoints
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.

Maximum observed plasma concentration (Cmax) for BMS-955176
Up to Day 4 of Period 4
Area under the plasma concentration-time curve from time zero to 72 hours post-dose [AUC(0-72)] for BMS-955176
Up to Day 4 of Period 4
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for BMS-955176
Up to Day 4 of Period 4
Plasma concentration at 24 hours post-dose (C24) for BMS-955176
Up to Day 4 of Period 4
Serial blood samples for plasma Ethinyl Estradiol and Norelgestromin determination
Before dosing (0 hour) through 24 hours after administration on Days 21 and 49
Maximum observed plasma concentration (Cmax) of BMS-955176
Days 1-4 of Periods 1, 2, 3 and 4
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-955176
Days 1-4 of Periods 1, 2, 3 and 4
Area under the plasma concentration-time curve from time zero to 72 hours post-dose [AUC(0-72)] of BMS-955176
Days 1-4 of Periods 1, 2, 3 and 4
Secondary Endpoints
Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C
Pre-dose Day 1 and Day 10
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)
Maximum Decline From Baseline in Log10 HIV-1 RNA - Part A and C
Baseline (Day 1) up to Day 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A-Group 1: BMS-955176 (5 mg) or PlaceboEXPERIMENTALBMS-955176 5 mg solution by mouth once daily for 10 days OR Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days
Part A-Group 2: BMS-955176 (10 mg) or PlaceboEXPERIMENTALBMS-955176 10 mg solution by mouth once daily for 10 days OR Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days
Part A-Group 3: BMS-955176 (20 mg) or PlaceboEXPERIMENTALBMS-955176 20 mg solution by mouth once daily for 10 days OR Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days
Part A-Group 4: BMS-955176 (40 mg) or PlaceboEXPERIMENTALBMS-955176 40 mg solution by mouth once daily for 10 days OR Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days
Part B-Group 5: BMS-955176 + AtazanavirEXPERIMENTALBMS-955176 40 mg solution by mouth once daily for 28 days Atazanavir 2 x 200 mg capsules by mouth once daily for 28 days
Part B-Group 6: BMS-955176 + Atazanavir + RitonavirEXPERIMENTALBMS-955176 40 mg solution by mouth once daily for 28 days Atazanavir 1 x 300 mg capsules by mouth once daily for 28 days Ritonavir 1 x 100 mg tablet by mouth once daily for 28 days
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+EmtricitabineEXPERIMENTALAtazanavir 1 x 300 mg capsule by mouth once daily for 28 days Ritonavir 1 x 100 mg tablet by mouth once daily for 28 days Tenofovir 1 x 300 mg tablet by mouth once daily for 28 days Emtricitabine 1 x 200 mg capsule once daily for 28 days
Part C-Group 8: BMS-955176 (40 mg) or PlaceboEXPERIMENTALBMS-955176 40 mg solution by mouth once daily for 10 days OR Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days
Part A-Group 9: BMS-955176 (80 mg) or PlaceboEXPERIMENTALBMS-955176 80 mg solution by mouth once daily for 10 days OR Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days
Part A-Group 10: BMS-955176 (120 mg) or PlaceboEXPERIMENTALBMS-955176 120 mg solution by mouth once daily for 10 days OR Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days
Part A-Group 11 (Optional): BMS-955176 (≤120 mg) or PlaceboEXPERIMENTALBMS-955176 ≤120 mg solution by mouth once daily for 14 days OR Placebo matching with BMS-955176 0 mg solution by mouth once daily for 14 days
Part B-Group 12: BMS-955176 (80 mg) + AtazanavirEXPERIMENTALBMS-955176 80 mg solution by mouth once daily for 28 days Atazanavir 2 x 200 mg capsules by mouth once daily for 28 days
Part C-Group 13: BMS-955176 (120 mg) or PlaceboEXPERIMENTALBMS-955176 120 mg solution by mouth once daily for 10 days OR Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days
Arm 1 (ABDC): BMS-955176EXPERIMENTALBMS-955176 single dose by mouth for each treatment as specified
Arm 2 (BCAD): BMS-955176EXPERIMENTALBMS-955176 single dose by mouth for each treatment as specified
Arm 3 (CDBA): BMS-955176EXPERIMENTALBMS-955176 single dose by mouth for each treatment as specified
Arm 4 (DACB): BMS-955176EXPERIMENTALBMS-955176 single dose by mouth for each treatment as specified
Arm 5 (EFHG): BMS-955176EXPERIMENTALBMS-955176 single dose by mouth for each treatment as specified
Arm 6 (FGEH): BMS-955176EXPERIMENTALBMS-955176 single dose by mouth for each treatment as specified
Arm 7 (GHFE): BMS-955176EXPERIMENTALBMS-955176 single dose by mouth for each treatment as specified
Arm 8 (HEGF): BMS-955176EXPERIMENTALBMS-955176 single dose by mouth for each treatment as specified
Arm 9 (IJK): BMS-955176EXPERIMENTALBMS-955176 single dose by mouth for each treatment specified
Arm 10 (JKI): BMS-955176EXPERIMENTALBMS-955176 single dose by mouth for each treatment specified
Arm 11 (KIJ): BMS-955176EXPERIMENTALBMS-955176 single dose by mouth for each treatment specified
Arm 12 (IKJ): BMS-955176EXPERIMENTALBMS-955176 single dose by mouth for each treatment specified
Arm 13 (JIK): BMS-955176EXPERIMENTALBMS-955176 single dose by mouth for each treatment specified
Arm 14 (KJI): BMS-955176EXPERIMENTALBMS-955176 single dose by mouth for each treatment specified
Arm 15 (LMN): BMS-955176EXPERIMENTALBMS-955176 single dose by mouth for each treatment specified
Arm 16 (OPQ): BMS-955176EXPERIMENTALBMS-955176 single dose by mouth for each treatment specified
Arm 17 (PQO): BMS-955176EXPERIMENTALBMS-955176 single dose by mouth for each treatment specified
Arm 18 (QOP): BMS-955176EXPERIMENTALBMS-955176 single dose by mouth for each treatment specified
Arm 19 (OQP): BMS-955176EXPERIMENTALBMS-955176 single dose by mouth for each treatment specified
Arm 20 (POQ): BMS-955176EXPERIMENTALBMS-955176 single dose by mouth for each treatment specified
Arm 21 (QPO): BMS-955176EXPERIMENTALBMS-955176 single dose by mouth for each treatment specified
Arm 1: NGMN/EE + BMS-955176EXPERIMENTALCycle 1- Active Ortho Cyclen QD on Days 1 to 21. Inert Ortho Cyclen tablets on Days 22 to 28 Cycle 2- Active Ortho Cyclen QD alone on Days 29 to 39 (11 days), followed by concomitant administration of active Ortho Cyclen QD + BMS-955176 80 mg QD on Days 40 to 49 (10 days)
Cohort 1 Arm ABDC: BMS-955176 (Treatment A, B, D and C)EXPERIMENTALBMS-955176 single dose by mouth as specified
Cohort 1 Arm BCDA: BMS-955176 (Treatment B, C, D and A)EXPERIMENTALBMS-955176 single dose by mouth as specified
Cohort 1 Arm DABC: BMS-955176 (Treatment D, A, B and C)EXPERIMENTALBMS-955176 single dose by mouth as specified
Cohort 1 Arm CDAB: BMS-955176 (Treatment C, D, A and B)EXPERIMENTALBMS-955176 single dose by mouth as specified
Cohort 2 Arm EFGH: BMS-955176 (Treatment E, F, G and H)EXPERIMENTALBMS-955176 single dose by mouth as specified
Cohort 2 Arm FGHE: BMS-955176 (Treatment F, G, H and E)EXPERIMENTALBMS-955176 single dose by mouth as specified
Cohort 2 Arm HEFG: BMS-955176 (Treatment H, E, F and G)EXPERIMENTALBMS-955176 single dose by mouth as specified
Cohort 2 Arm GHEF: BMS-955176 (Treatment G, H, E and F)EXPERIMENTALBMS-955176 single dose by mouth as specified
Interventions
NameTypeDescription
BMS-955176DRUGBMS-955176
Placebo matching with BMS-955176DRUGPlacebo matching with BMS-955176
AtazanavirDRUGAtazanavir
RitonavirDRUGRitonavir
TenofovirDRUGTenofovir
EmtricitabineDRUGEmtricitabine
Ortho CyclenDRUG -
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

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/...

Countries:GermanyUnited Kingdom
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