A Study to Evaluate the Bioavailability of BMS-986205

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: BMS-986205

Study type: Interventional

Funder types: Industry

Identifiers

NCT03374228

2017-003100-51 (EudraCT Number)

CA017-060

Details and patient eligibility

About

Assess the absolute bioavailability of a tablet formulation of BMS-986205 following simultaneous oral administration of BMS-986205 and intravenous infusion of [13C]BMS-986205 solution for intravenous administration in healthy participants.

Enrollment: 7 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) 18.0 to 32.0 kg/m2, inclusive
• Must have normal renal function demonstrated by an estimated glomerular filtration rate, calculated by Chronic Kidney Disease Epidemiology Collaboration formula
• Women must not be of childbearing potential (cannot become pregnant)

Exclusion criteria

• Women who are of childbearing potential or breastfeeding
• Any significant acute or chronic medical illness
• Active tuberculosis (TB) requiring treatment or documented latent TB at screening

Other protocol defined inclusion / exclusion criteria could apply

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

7 participants in 1 patient group

BMS-986205

Experimental group

Description:

Single oral dose of BMS-986205 tablet on the morning of Day 1 followed by a 15-minute infusion of \[13C\]BMS-986205 solution for intravenous administration starting 01:45 hours after the oral dose administration

Treatment:

Drug: BMS-986205