Trials / Completed
CompletedNCT03891108
A Pharmacokinetics, Safety and Tolerability Study of Multiple Formulations of BMS-986231 in Healthy Participants
A Randomized, Open Label, Parallel Design, Single Continuous Intravenous Infusion Study of BMS-986231 to Assess the Pharmacokinetics, Safety and Tolerability of Multiple Formulations in Healthy Participants
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
Summary
Main Objective of this study is to compare the single intravenous (IV) infusion pharmacokinetics (PK) of BMS-986231 and its metabolites (BMT-284730, BMT-279554, and CAR-000463) following of up to 2 test formulations of BMS-986231 relative to the reference formulation.
Detailed description
Participants will be randomized 1:1:1:1 and dosed with either of the 4 treatments: A, B, C, or D; followed by review of safety and tolerability data during and after the infusion. The study will proceed with treatments A, and C unless one or more of these treatments shows poor tolerability; in which case the study may proceed with treatment B or D in the follow-up cohorts. Additional participants will be randomized equally to each of the treatments the study will proceed with.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BMS-986231 Formulation A | Participants will be administered BMS-986231 Formulation A as IV infusion for 48 hours. |
| DRUG | BMS-986231 Formulation B | Participants will be administered BMS-986231 Formulation B as IV infusion for 48 hours. |
| DRUG | BMS-986231 Formulation C | Participants will be administered BMS-986231 Formulation C as IV infusion for 48 hours. |
| DRUG | BMS-986231 Formulation D | Participants will be administered BMS-986231 Formulation D as IV infusion for 48 hours. |
Timeline
- Start date
- 2019-02-28
- Primary completion
- 2019-07-29
- Completion
- 2019-07-29
- First posted
- 2019-03-26
- Last updated
- 2019-10-01
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03891108. Inclusion in this directory is not an endorsement.