Study With Healthy Japanese and Non-Asian Participants With BMS-986231
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 6/1/2017 |
| Start Date: | October 4, 2016 |
| End Date: | May 26, 2017 |
A Randomized, Double-Blind, Placebo-controlled, Single Continuous Intravenous Infusion Study of BMS-986231 to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Japanese and Non- Asian Participants
The purpose of this Phase 1 study is to evaluate the safety, tolerability, PK, and
pharmacodynamics (PD) of BMS-986231 in healthy Japanese and Non-Asian participants. There is
no formal hypothesis to be statistically tested.
pharmacodynamics (PD) of BMS-986231 in healthy Japanese and Non-Asian participants. There is
no formal hypothesis to be statistically tested.
Inclusion Criteria:
- Ancestry
- First generation Japanese
- Non-Asian with grandparents and parents of non-Asian descent
- Body weight greater than or equal to 45kg and less than or equal to 110kg
- Women of childbearing potential have specific birthcontrol methods
- Males sexually active with women of childbearing potential have specific birthcontrol
methods
Exclusion Criteria:
- History of chronic illness
- Chronic headaches
- Recurrent dizziness
- Personal or family history of heart disease
- Personal history of bleeding diathesis
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