A Study to Assess the Absorption of a Single Dose of BMS-... | NCT03362411

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BMS-986205 intact tablet orally then crushed tablet orally	Experimental	Single, 100 mg dose	Drug: BMS-986205
BMS-986205 crushed tablet orally, then intact tablet orally	Experimental	Single, 100 mg dose	Drug: BMS-986205
BMS-986205 intact tablet orally then suspension via NG tube	Experimental	Single, 100 mg dose	Drug: BMS-986205
BMS-986205 suspension via NG tube then intact tablet orally	Experimental	Single, 100 mg dose	Drug: BMS-986205

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BMS-986205	Drug	Single 100 mg dose on Day 1 and Day 15	BMS-986205 crushed tablet orally, then intact tablet orally BMS-986205 intact tablet orally then crushed tablet orally

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum observed plasma concentration (Cmax) of single 100 mg dose of BMS-986205 administered orally as crushed tablet on soft food compared to intact tablet administered orally.	Measured by plasma concentration.	Up to 22 days
Maximum observed plasma concentration (Cmax) of single 100 mg dose of BMS-986205 administered via nasogastric (NG) tube as crushed tablet suspension compared to intact tablet administered orally.	Measured by plasma concentration.	Up to 22 days
Area under the plasma concentration time curve from time zero to 168 hours after dosing (AUC[0-168]) of single 100 mg dose of BMS-986205 administered orally as crushed tablet on soft food compared to intact tablet administered orally.	Measured by plasma concentration.	Up to 22 days
Area under the plasma concentration time curve from time zero to 168 hours after dosing (AUC[0-168]) of single 100 mg dose of BMS-986205 administered via nasogastric (NG) tube as crushed tablet suspension compared to intact tablet administered orally.	Measured by plasma concentration.	Up to 22 days

Secondary Outcomes

Measure	Description	Time Frame
Incidence of non-serious Adverse Events (AEs).	Safety and tolerability as measured by incidence of non-serious AEs.	Up to 22 days
Incidence of Serious Adverse Events (SAEs).	Safety and tolerability as measured by incidence of SAEs.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed written consent form.
Healthy male and female participants (not of childbearing potential), determined by no clinically significant deviation from normal in medical history, physical examination, ECGs (electrocardiograms) and clinical laboratory determinations.
Women participants must have documented proof they are not of childbearing potential.
Males sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for duration of treatment with BMS-986205, and for a total of 110 days after the last dose of BMS-986205; and must be willing to refrain from sperm donation during this time. Azoospermic males are exempt from contraceptive requirements.
Normal renal function at screening (Glomerula Filtration Rate ≥ 80 mL/min/1.73 m2).
Body Mass Index (BMI) of 18.0 kg/m2 to 32.0 kg/m2 inclusive.

Exclusion Criteria:

Women who are of childbearing potential or breastfeeding.
Any significant acute or chronic illness.
Active tuberculosis (TB) requiring treatment, documented latent TB within the previous 3 years, or evidence of a past TB infection without documented adequate therapy. All participants will be required to have a QuantiFERON -TB Gold test performed at screening.
History of Glucose-6-Phosphate Dehydrogenase deficiency (G6PD) or any other congenital hemolytic anemias.
History of cardiac arrhythmias and/or autonomic instability.
History of pulmonary, renal or liver disease.
History of Gilbert's Syndrome.
Recent (within 6 months of study drug administration) history of smoking or current smokers, including use of electronic cigarettes or nicotine-containing products such as tobacco for chewing, nicotine patches, nicotine lozenges or nicotine gum.
Participants with active, known or suspected autoimmune disease. Participants with vitiligo or psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger may enroll.
Major surgery within 4 weeks of study drug administration.

Other protocol defined inclusion/exclusion criteria could apply.