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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03378310
• Other study ID #: CA017-069
• Status: Completed
• Phase: Phase 1
• First received: December 15, 2017
• Last updated: February 26, 2018
• Start date: December 21, 2017
• Est. completion date: February 22, 2018

Study information

• Verified date: February 2018
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 22, 2018
• Est. primary completion date: February 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• BMS-986205 reference tablet
Single, 100 mg oral dose.
• BMS-986205 tablet with free base
Single, 100 mg oral dose.

Locations

Country	Name	City	State
United States	PPD Austin Clinic	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) of BMS-986205 tablet with free base compared to reference tablet.	Measured by plasma concentration.	Up to Day 22
Primary	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	Incidence of non-serious Adverse Events (AEs).	Safety and tolerability as measured by incidence of non-serious AEs.	Up to Day 22
Secondary	Incidence of Serious Adverse Events (SAEs).	Safety and tolerability as measured by incidence of SAEs.	Up to Day 22
Secondary	Incidence of Adverse Events (AEs) leading to discontinuation.	Safety and tolerability as measured by incidence of AEs leading to discontinuation.	Up to Day 22
Secondary	Number of participants with vital sign abnormalities.		Up to Day 22
Secondary	Number of participants with electrocardiogram (ECG) abnormalities.		Up to Day 22
Secondary	Number of participants with clinical laboratory abnormalities.		Up to Day 22
Secondary	Number of participants with physical examination abnormalities.		Up to Day 22

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form