Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as HIV Maturation Inhibitor
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 developed by GSK plc for HIV infections and human immunodeficiency virus. It has been studied in Phase 1 clinical trials, all of which are completed. It is not approved and remains in clinical development.
BMS-955176 is being developed by GSK plc, which trades under the ticker GSK. The compound is an investigational small molecule in the infectious disease therapeutic area, studied for HIV infections and human immunodeficiency virus.
BMS-955176 is in Phase 1. Four Phase 1 trials have been conducted, and all four are completed, with no active trials ongoing. The studies enrolled a total of 212 participants. The drug is investigational and has not been approved.
BMS-955176 has been studied in four completed Phase 1 trials: NCT02608918, which examined taste properties; NCT02273947, a food effect study; NCT02206711, an absorption, metabolism, and elimination study; and NCT02157467, which assessed combined oral contraceptive effects in female subjects.
Yes, BMS955176 is an alternative spelling of BMS-955176, the same investigational small molecule developed by GSK plc for HIV infections and human immunodeficiency virus. Both names refer to the identical compound studied in the completed Phase 1 trials.