A Study in Healthy Participants Evaluating the Absorption of a BMS-986205 Tablet Into the Bloodstream Compared to a Reference Tablet
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 1/21/2018 |
| Start Date: | December 21, 2017 |
| End Date: | February 8, 2018 |
| Contact: | Recruiting sites have contact information. Please consult the sites directly. If there is no contact information |
| Email: | Clinical.Trials@bms.com |
| Phone: | please email: |
A Randomized, Open-Label Study to Evaluate the Bioavailability of a BMS-986205 Tablet Containing Free Base Relative to a Reference Tablet in Healthy Participants
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 will be randomly assigned to 1 of 2 treatment sequences and will
receive a single, oral dose of BMS-986205 twice over 22 days. Participants must remain at the
clinical facility for the duration of the study.
absorption of a BMS-986205 tablet into the bloodstream compared to a reference tablet.
Eligible participants will be randomly assigned to 1 of 2 treatment sequences and will
receive a single, oral dose of BMS-986205 twice over 22 days. Participants must remain at the
clinical facility for the duration of the study.
Inclusion Criteria:
- 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 Criteria:
- 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.
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