Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BMS-955176 · 6 trials · 2 indications
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.
Serial blood samples for PK parameters determined from plasma concentration versus time
Sample of urinary/fecal/bile will be collected for determining total recovery.
| Arm | Type | Description |
|---|---|---|
| Part A-Group 1: BMS-955176 (5 mg) or Placebo | EXPERIMENTAL | BMS-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 Placebo | EXPERIMENTAL | BMS-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 Placebo | EXPERIMENTAL | BMS-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 Placebo | EXPERIMENTAL | BMS-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 + Atazanavir | EXPERIMENTAL | BMS-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 + Ritonavir | EXPERIMENTAL | BMS-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+Emtricitabine | EXPERIMENTAL | Atazanavir 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 Placebo | EXPERIMENTAL | BMS-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 Placebo | EXPERIMENTAL | BMS-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 Placebo | EXPERIMENTAL | BMS-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 Placebo | EXPERIMENTAL | BMS-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) + Atazanavir | EXPERIMENTAL | BMS-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 Placebo | EXPERIMENTAL | BMS-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 |
| BMS-955176 | EXPERIMENTAL | BMS-955176 specified dose on specified days |
| Arm 1 (ABDC): BMS-955176 | EXPERIMENTAL | BMS-955176 single dose by mouth for each treatment as specified |
| Arm 2 (BCAD): BMS-955176 | EXPERIMENTAL | BMS-955176 single dose by mouth for each treatment as specified |
| Arm 3 (CDBA): BMS-955176 | EXPERIMENTAL | BMS-955176 single dose by mouth for each treatment as specified |
| Arm 4 (DACB): BMS-955176 | EXPERIMENTAL | BMS-955176 single dose by mouth for each treatment as specified |
| Arm 5 (EFHG): BMS-955176 | EXPERIMENTAL | BMS-955176 single dose by mouth for each treatment as specified |
| Arm 6 (FGEH): BMS-955176 | EXPERIMENTAL | BMS-955176 single dose by mouth for each treatment as specified |
| Arm 7 (GHFE): BMS-955176 | EXPERIMENTAL | BMS-955176 single dose by mouth for each treatment as specified |
| Arm 8 (HEGF): BMS-955176 | EXPERIMENTAL | BMS-955176 single dose by mouth for each treatment as specified |
| Arm 9 (IJK): BMS-955176 | EXPERIMENTAL | BMS-955176 single dose by mouth for each treatment specified |
| Arm 10 (JKI): BMS-955176 | EXPERIMENTAL | BMS-955176 single dose by mouth for each treatment specified |
| Arm 11 (KIJ): BMS-955176 | EXPERIMENTAL | BMS-955176 single dose by mouth for each treatment specified |
| Arm 12 (IKJ): BMS-955176 | EXPERIMENTAL | BMS-955176 single dose by mouth for each treatment specified |
| Arm 13 (JIK): BMS-955176 | EXPERIMENTAL | BMS-955176 single dose by mouth for each treatment specified |
| Arm 14 (KJI): BMS-955176 | EXPERIMENTAL | BMS-955176 single dose by mouth for each treatment specified |
| Arm 15 (LMN): BMS-955176 | EXPERIMENTAL | BMS-955176 single dose by mouth for each treatment specified |
| Arm 16 (OPQ): BMS-955176 | EXPERIMENTAL | BMS-955176 single dose by mouth for each treatment specified |
| Arm 17 (PQO): BMS-955176 | EXPERIMENTAL | BMS-955176 single dose by mouth for each treatment specified |
| Arm 18 (QOP): BMS-955176 | EXPERIMENTAL | BMS-955176 single dose by mouth for each treatment specified |
| Arm 19 (OQP): BMS-955176 | EXPERIMENTAL | BMS-955176 single dose by mouth for each treatment specified |
| Arm 20 (POQ): BMS-955176 | EXPERIMENTAL | BMS-955176 single dose by mouth for each treatment specified |
| Arm 21 (QPO): BMS-955176 | EXPERIMENTAL | BMS-955176 single dose by mouth for each treatment specified |
| Single oral dose of [14C] BMS 955176 | EXPERIMENTAL | A single 180 mg oral dose of \[14C\] BMS-955176 containing approximately 80 microcurie of total radioactivity. |
| Nasoduodenal (ND) Tube Cohort | EXPERIMENTAL | A single dose of \[14C\] BMS 955176 on Day 1 with ND placement 1 hour post dose to facilitate continuous bile collection though 8 hours post dose. |
| Arm 1: NGMN/EE + BMS-955176 | EXPERIMENTAL | Cycle 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) | EXPERIMENTAL | BMS-955176 single dose by mouth as specified |
| Cohort 1 Arm BCDA: BMS-955176 (Treatment B, C, D and A) | EXPERIMENTAL | BMS-955176 single dose by mouth as specified |
| Cohort 1 Arm DABC: BMS-955176 (Treatment D, A, B and C) | EXPERIMENTAL | BMS-955176 single dose by mouth as specified |
| Cohort 1 Arm CDAB: BMS-955176 (Treatment C, D, A and B) | EXPERIMENTAL | BMS-955176 single dose by mouth as specified |
| Cohort 2 Arm EFGH: BMS-955176 (Treatment E, F, G and H) | EXPERIMENTAL | BMS-955176 single dose by mouth as specified |
| Cohort 2 Arm FGHE: BMS-955176 (Treatment F, G, H and E) | EXPERIMENTAL | BMS-955176 single dose by mouth as specified |
| Cohort 2 Arm HEFG: BMS-955176 (Treatment H, E, F and G) | EXPERIMENTAL | BMS-955176 single dose by mouth as specified |
| Cohort 2 Arm GHEF: BMS-955176 (Treatment G, H, E and F) | EXPERIMENTAL | BMS-955176 single dose by mouth as specified |
| Name | Type | Description |
|---|---|---|
| BMS-955176 | DRUG | BMS-955176 |
| Placebo matching with BMS-955176 | DRUG | Placebo matching with BMS-955176 |
| Atazanavir | DRUG | Atazanavir |
| Ritonavir | DRUG | Ritonavir |
| Tenofovir | DRUG | Tenofovir |
| Emtricitabine | DRUG | Emtricitabine |
| Ortho Cyclen | DRUG | - |
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/...
BMS-955176 is an investigational small molecule being developed for the treatment of HIV infections, including Human Immunodeficiency Virus infection. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in healthy volunteers to evaluate its safety, tolerability, and pharmacological properties.
BMS-955176 is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is in Phase 1 clinical development for the treatment of HIV infections. GSK is conducting clinical trials to evaluate the drug's properties in healthy volunteers.
BMS-955176 is in Phase 1 clinical development. It is an investigational drug for the treatment of HIV infections and has not been approved by regulatory authorities. All four clinical trials for BMS-955176 have been completed, with a total enrollment of 212 participants across the studies.
BMS-955176 has completed four Phase 1 clinical trials. These include NCT02157467, a study of combined oral contraceptive effects in female subjects; NCT02206711, a study of absorption, metabolism, and elimination; NCT02273947, a food effect study; and NCT02608918, a study of taste properties. All trials were conducted in healthy volunteers.
BMS-955176 is an investigational small molecule being developed by GSK plc for the treatment of HIV infections. It is currently in Phase 1 clinical development and has not been approved. The drug is being studied in healthy volunteers to evaluate its properties, including absorption, metabolism, and elimination.