A Study in Healthy Participants Evaluating the Absorption of a BMS-986205 Tablet Into the Bloodstream Compared to a Reference Tablet

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: BMS-986205 reference tablet; Drug: BMS-986205 tablet with free base

Study type: Interventional

Funder types: Industry

Identifiers

NCT03378310

CA017-069

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

16 participants in 2 patient groups

Reference tablet followed by BMS-986205 tablet with free base

Experimental group

Description:

BMS-986205 reference tablet (treatment period 1) followed by BMS-986205 tablet with free base (treatment period 2).

Treatment:

Drug: BMS-986205 tablet with free base

Drug: BMS-986205 reference tablet

BMS-986205 tablet with free base followed by reference tablet

Experimental group

Description:

BMS-986205 tablet with free base (treatment period 1) followed by BMS-986205 reference tablet (treatment period 2).

Treatment:

Drug: BMS-986205 tablet with free base

Drug: BMS-986205 reference tablet