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

A Randomized, Open-Label Study to Evaluate the Bioavailability of a BMS-986205 Tablet Containing Free Base Relative to a Reference Tablet in Healthy Participants

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: BMS-986205 reference tablet; Drug: BMS-986205 tablet with free base

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • PPD Austin Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reference tablet followed by BMS-986205 tablet with free base; BMS-986205 reference tablet (treatment period 1) followed by BMS-986205 tablet with free base (treatment period 2).	Drug: BMS-986205 reference tablet; Single, 100 mg oral dose.; Drug: BMS-986205 tablet with free base; Single, 100 mg oral dose.
Experimental: BMS-986205 tablet with free base followed by reference tablet; BMS-986205 tablet with free base (treatment period 1) followed by BMS-986205 reference tablet (treatment period 2).	Drug: BMS-986205 reference tablet; Single, 100 mg oral dose.; Drug: BMS-986205 tablet with free base; Single, 100 mg oral dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum observed plasma concentration (Cmax) of BMS-986205 tablet with free base compared to reference tablet.	Measured by plasma concentration.	Up to Day 22
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.	Measured by plasma concentration.	Up to Day 22

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2017
• Primary Completion (Actual): February 15, 2018
• Study Completion (Actual): February 22, 2018

Study Registration Dates

• First Submitted: December 15, 2017
• First Submitted That Met QC Criteria: December 18, 2017
• First Posted (Actual): December 19, 2017

Study Record Updates

• Last Update Posted (Actual): February 28, 2018
• Last Update Submitted That Met QC Criteria: February 26, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Linrodostat
• Other Study ID Numbers: CA017-069

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No