Status:
COMPLETED
A Study to Evaluate the Effect of 2 Drugs on the Pharmacokinetics of BMS-986205 in Healthy Subjects
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Malignancies Multiple
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
Assess the effects of itraconazole and rifampin on the pharmacokinetics, safety, and tolerability of BMS-986205.
Detailed Description
A randomized, open-label, parallel design study in healthy participants to assess the effects of itraconazole and rifampin on the single-dose pharmacokinetics of BMS-986205. Safety and tolerability da...
Eligibility Criteria
Inclusion
- Body mass index 18.0 to 32.0 kg/m2, inclusive
- Must have normal renal function demonstrated by GFR, calculated by Chronic Kidney Disease Epidemiology Collaboration formula
- Women must not be of childbearing potential (cannot become pregnant)
Exclusion
- Any significant acute or chronic medical illness
- History of glucose-6-phosphodiesterase (G6PD) deficiency
- Personal or family history of cytochrome b5 reductase deficiency
- Other protocol defined inclusion / exclusion criteria could apply
Key Trial Info
Start Date :
November 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2017
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT03346837
Start Date
November 22 2017
End Date
December 20 2017
Last Update
February 28 2018
Active Locations (1)
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1
PPD
Austin, Texas, United States, 78744