Clinical trial NCT03378310: A Study in Healthy Participants Evaluating the Absorption of a BMS-986205 Tablet Into the Bloodstream Compared to a Reference Tablet
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-12-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of BMS-986205 tablet with free base compared to reference tablet.
timeFrame: Up to Day 22
measure: 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.
timeFrame: Up to Day 22
Secondary outcomes:
measure: Incidence of non-serious Adverse Events (AEs).
timeFrame: Up to Day 22
measure: Incidence of Serious Adverse Events (SAEs).
timeFrame: Up to Day 22
measure: Incidence of Adverse Events (AEs) leading to discontinuation.
timeFrame: Up to Day 22
measure: Number of participants with vital sign abnormalities.
timeFrame: Up to Day 22
measure: Number of participants with electrocardiogram (ECG) abnormalities.
timeFrame: Up to Day 22
measure: Number of participants with clinical laboratory abnormalities.
timeFrame: Up to Day 22
measure: Number of participants with physical examination abnormalities.
timeFrame: Up to Day 22
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Austin Clinic
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: