Status:
WITHDRAWN
A Single and Multiple Ascending Dose Study of BMS-986318 in Healthy Participants
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
A study to evaluate single and multiple ascending doses of experimental medicine BMS-986318 in healthy participants.
Detailed Description
A Phase 1, Double-Blind, Placebo-Controlled, Randomized Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Exploratory Pharmacodynamics of Oral BMS-98...
Eligibility Criteria
Inclusion
- Healthy Participants as determined by no clinically significant deviations from normal in medical history, physical examination, ECG and clinical laboratory results as determined by the investigator
- Male participants who are sexually active with Women of Child Bearing Potential (WOCBP) must agree to follow instructions for methods of contraception for duration of treatment plus 92 days.
- Female participants must have documented proof that they are not of childbearing potential and a negative pregnancy test at screening and within 24 hours before the first dose of study treatment.
Exclusion
- Use of any prescription drugs within 4 weeks or use of over-the-counter (OTC) medications or herbal preparations within 2 weeks prior to study treatment administration (except acid controllers, which are not allowed within 4 weeks prior to study treatment administration
- Women of Child Bearing Potential (WOCBP) or women who are breastfeeding.
- Any major surgery within 12 weeks of study administration Or any history of GI surgeries as listed.(eg, gastric bypass, gastric banding, Roux-en-Y) or gastric- emptying issues that could impact upon the absorption of nutrients.
Key Trial Info
Start Date :
July 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 12 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04082741
Start Date
July 18 2019
End Date
September 12 2019
Last Update
January 27 2020
Active Locations (1)
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1
PRA Health Sciences - Lenexa
Lenexa, Kansas, United States, 66219