Status:
COMPLETED
A Study in Healthy Participants Evaluating the Absorption of a BMS-986205 Tablet Into the Bloodstream Compared to a Reference Tablet
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This is a Phase 1, open-label, randomized study in healthy participants to evaluate the absorption of a BMS-986205 tablet into the bloodstream compared to a reference tablet. Eligible participants wil...
Eligibility Criteria
Inclusion
- Signed, written informed consent.
- Healthy male and female participants (not of childbearing potential), determined by medical history, physical examination, electrocardiograms (ECGs) and clinical laboratory tests.
- Normal renal (kidney) function.
- Body Mass Index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive.
- Women must have documented proof they are not of childbearing potential.
- Males who are sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment and 110 days after the last dose of BMS-986205. In addition, male participants must be willing to refrain from sperm donation during this time.
Exclusion
- Women of childbearing potential or breastfeeding.
- Active tuberculosis (TB) requiring treatment or documented latent TB within the previous 3 years. Also excluded are participants with evidence of a past TB infection without documented adequate therapy.
- History of pulmonary, renal, or liver disease; or of cardiac arrhythmias.
- Recent (within 6 months of study drug administration) history of smoking or current smokers. This includes participants using electronic cigarettes or nicotine-containing products such as tobacco for chewing, nicotine patches, nicotine lozenges or nicotine gum.
- Donation of blood to a blood bank or in a clinical study (except screening or follow-up visit) within 4 weeks of study drug administration (within 2 weeks for plasma only).
- Other protocol defined inclusion/exclusion criteria could apply.
Key Trial Info
Start Date :
December 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2018
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03378310
Start Date
December 21 2017
End Date
February 22 2018
Last Update
February 28 2018
Active Locations (1)
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1
PPD Austin Clinic
Austin, Texas, United States, 78744