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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: BMS-986205 reference tablet; Drug: BMS-986205 tablet with free base

• Registration Number: NCT03378310
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

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: 2017-12-15
• Study First Submitted QC: 2017-12-18
• Study First Posted: 2017-12-19
• Study Start: 2017-12-21
• Status Verified: 2018-02
• Primary Completion: 2018-02-15
• Study Completion: 2018-02-22
• Last Update Submitted: 2018-02-26
• Last Update Posted: 2018-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax) of BMS-986205 tablet with free base compared to reference tablet.	Up to Day 22	Measured by plasma concentration.
Area under the plasma concentration time curve from time zero to 168 hours after dosing (AUC[0-168]) of BMS-986205 tablet with free base compared to reference tablet.	Up to Day 22	Measured by plasma concentration.

Secondary Outcome Measures

Name	Time	Method
Incidence of non-serious Adverse Events (AEs).	Up to Day 22	Safety and tolerability as measured by incidence of non-serious AEs.
Incidence of Serious Adverse Events (SAEs).	Up to Day 22	Safety and tolerability as measured by incidence of SAEs.
Number of participants with vital sign abnormalities.	Up to Day 22
Number of participants with clinical laboratory abnormalities.	Up to Day 22
Incidence of Adverse Events (AEs) leading to discontinuation.	Up to Day 22	Safety and tolerability as measured by incidence of AEs leading to discontinuation.
Number of participants with physical examination abnormalities.	Up to Day 22
Number of participants with electrocardiogram (ECG) abnormalities.	Up to Day 22

Trial Locations

Locations (1)

PPD Austin Clinic; 🇺🇸 Austin, Texas, United States