A Study to Evaluate the Bioavailability of BMS-986205

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: BMS-986205

• Registration Number: NCT03374228
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-12-12
• Study First Submitted QC: 2017-12-12
• Study First Posted: 2017-12-15
• Study Start: 2018-01-04
• Primary Completion: 2018-02-16
• Study Completion: 2018-02-16
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-26
• Last Update Posted: 2018-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BMS-986205	BMS-986205	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

Primary Outcome Measures

Name	Time	Method
Absolute oral bioavailability (F)	Up to 15 days	Measured by plasma concentration

Secondary Outcome Measures

Name	Time	Method
Number of participants with electrocardiogram abnormalities	Up to 15 days
Occurrence of adverse events (AEs) leading to discontinuation	Up to 15 days	Safety and tolerability as measured by incidence of AEs leading to discontinuation
Occurrence of adverse events (AEs)	Up to 15 days	Safety and tolerability as measured by incidence of AEs
Occurrence of serious adverse events (SAEs)	Up to 15 days	Safety and tolerability as measured by incidence of SAEs
Number of participants with vital sign measurement abnormalities	Up to 15 days
Number of participants with clinical laboratory test abnormalities	Up to 15 days
Number of participants with physical examination abnormalities	Up to 15 days

Trial Locations

Locations (1)

Quotient Clinical; 🇬🇧 Nottingham, Ruddington Fields, United Kingdom