A Study to Assess the Absorption of a Single Dose of BMS-986205 in Healthy Volunteers When Administered as a Crushed Tablet Orally or Crushed Tablet Suspension Via Nasogastric Tube, as Compared to a Tablet
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 2/24/2018 |
| Start Date: | November 9, 2017 |
| End Date: | February 1, 2018 |
Randomized, Open-Label Study to Assess the Relative Bioavailability of a Single 100-mg Dose of BMS-986205 in Healthy Participants When Administered as a Crushed Tablet Orally or Crushed Tablet Suspension Via Nasogastric Tube Compared to an Intact Tablet of Similar Dose
The purpose of this study is to evaluate the absorption of BMS-986205 into the bloodstream of
healthy volunteers, when administered as an intact tablet taken orally, or as a crushed
tablet taken orally with soft food, or as a crushed tablet suspension taken via a nasogastric
(NG) tube. Eligible participants will be randomly assigned to 1 of 4 treatment sequences and
will receive a single dose of BMS-986205 twice during the course of the study.
healthy volunteers, when administered as an intact tablet taken orally, or as a crushed
tablet taken orally with soft food, or as a crushed tablet suspension taken via a nasogastric
(NG) tube. Eligible participants will be randomly assigned to 1 of 4 treatment sequences and
will receive a single dose of BMS-986205 twice during the course of the study.
Inclusion Criteria:
- Signed written consent form.
- Healthy male and female participants (not of childbearing potential), determined by no
clinically significant deviation from normal in medical history, physical examination,
ECGs (electrocardiograms) and clinical laboratory determinations.
- Women participants must have documented proof they are not of childbearing potential.
- Males sexually active with women of childbearing potential must agree to follow
instructions for method(s) of contraception for duration of treatment with BMS-986205,
and for a total of 110 days after the last dose of BMS-986205; and must be willing to
refrain from sperm donation during this time. Azoospermic males are exempt from
contraceptive requirements.
- Normal renal function at screening (Glomerula Filtration Rate ≥ 80 mL/min/1.73 m2).
- Body Mass Index (BMI) of 18.0 kg/m2 to 32.0 kg/m2 inclusive.
Exclusion Criteria:
- Women who are of childbearing potential or breastfeeding.
- Any significant acute or chronic illness.
- Active tuberculosis (TB) requiring treatment, documented latent TB within the previous
3 years, or evidence of a past TB infection without documented adequate therapy. All
participants will be required to have a QuantiFERON -TB Gold test performed at
screening.
- History of Glucose-6-Phosphate Dehydrogenase deficiency (G6PD) or any other congenital
hemolytic anemias.
- History of cardiac arrhythmias and/or autonomic instability.
- History of pulmonary, renal or liver disease.
- History of Gilbert's Syndrome.
- Recent (within 6 months of study drug administration) history of smoking or current
smokers, including use of electronic cigarettes or nicotine-containing products such
as tobacco for chewing, nicotine patches, nicotine lozenges or nicotine gum.
- Participants with active, known or suspected autoimmune disease. Participants with
vitiligo or psoriasis not requiring systemic treatment, or conditions not expected to
recur in the absence of an external trigger may enroll.
- Major surgery within 4 weeks of study drug administration.
Other protocol defined inclusion/exclusion criteria could apply.
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