Trials / Completed
CompletedNCT04965389
A Study of Milvexian Using an IV Microtracer With Additional Formulation and Food Effect Comparison in Healthy Participants
A Study to Assess the Absolute Oral Bioavailability of Milvexian Using a 14C-Microtracer and Oral Solution in Healthy Participants With Additional Food Effect Comparison of a Spray-Dried Dispersion Formulation of Milvexian in Capsules
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the absolute oral bioavailability (amount of drug entering the bloodstream) of spray-dried dispersion (SDD) milvexian capsules in the fed and fasted states, and to bridge the exposures seen using only the oral solution.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BMS-986177 Oral Solution | Specified dose on specified days |
| DRUG | [14C]BMS-986177 Solution for Infusion | Specified dose on specified days |
| DRUG | BMS-986177 Spray-dried Dispersion Capsules | Specified dose on specified days |
Timeline
- Start date
- 2021-07-16
- Primary completion
- 2021-08-22
- Completion
- 2021-10-01
- First posted
- 2021-07-16
- Last updated
- 2023-08-21
- Results posted
- 2023-08-21
Locations
1 site across 1 country: United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04965389. Inclusion in this directory is not an endorsement.