A Study of BMS-986195 in Healthy Male Subjects

Pharmacokinetics and Metabolism of [14C] BMS-986195 in Healthy Male Subjects

The purpose of this study is to investigate the effects BMS-986195 in healthy male subjects.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: BMS-986195

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9728 NZ
    • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Male subjects, if not surgically sterilized, must agree to use adequate contraception
• Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive (BMI = weight [kg]/[height (m)]2), and total body weight >50 kg
• All prescribed medication, including live vaccinations, must have been stopped at least 30 days prior to admission to the clinical research center
• All over-the-counter (OTC ) medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John's Wort) must have been stopped at least 14 days prior to admission to the clinical research center
• Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks), and grapefruit (juice) from 3 days prior to admission to the clinical research center
• Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG and vital signs, as judged by the Principal Investigator

Exclusion Criteria:

• Previous participation in the current study
• Known previous exposure to BMS-986195
• Employee of PRA or the Sponsor
• History of relevant drug and/or food allergies, including allergy to immunologic or related compounds or allergy to seafood or marine products
• Using tobacco products within 60 days prior to drug administration
• Positive screen for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies

Other protocol defined inclusion/exclusion criteria could apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BMS-986195; A single oral solution dose of BMS-986195	Drug: BMS-986195; specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma concentration (Cmax)	Up to 16 days
Time to attain maximum observed plasma concentration (tmax)	Up to 16 days
Area under the plasma concentration-time curve up to time t, where t is the last point with concentrations above the lower limit of quantitation [AUC(t-0)]	Up to 16 days
Area under the plasma concentration-time curve from time 0 to infinity calculated as: AUC0-inf = AUC0-t + Ĉlast/kel [AUC(0-inf)]	Up to 16 days
Percentage of estimated part for the calculation of AUC0-inf (%AUCextra)	Up to 16 days
Terminal elimination rate constant (kel)	Up to 16 days
Terminal elimination half life, calculated as 0.693/kel (t1/2)	Up to 16 days
Apparent oral clearance, calculated as dose/AUC0-inf (CL/F)	Up to 16 days
Apparent volume of distribution at terminal phase (Vz/F)	Up to 16 days
Ratio of AUC0-inf of BMS-986195 relative to total radioactivity (TRA) (%)	Up to 16 days
Ratio of AUC0-inf of plasma TRA relative to blood TRA (%)	Up to 16 days
Cumulative amount of TRA excreted in urine (Aeurine)	Up to 16 days
Cumulative amount of TRA excreted in feces (Aefeces)	Up to 16 days
Cumulative amount of TRA excreted in bile (Aebile)	Up to 16 days
Total amount of TRA excreted, calculated as Aetotal = Aeurine + Aefeces	Up to 16 days
Fraction of the dose administered excreted in urine (feurine)	Up to 16 days
Fraction of the dose administered excreted in feces (fefeces)	Up to 16 days
Fraction of the dose administered excreted in bile (febile)	Up to 16 days
Fraction of the dose administered excreted in urine and feces (fetotal)	Up to 16 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of adverse events (AE)	Up to 16 days
Number of serious adverse events (SAE)	Up to 16 days
Number of laboratory test result abnormalities	Up to 16 days
Heart rate measured by ECG	Up to 16 days
PR-interval measured by ECG	Up to 16 days
QRS-duration measured by ECG	Up to 16 days
QT-interval measured by ECG	Up to 16 days
QTc-interval (Fridericia's) measured by ECG	Up to 16 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2017
• Primary Completion (Actual): September 22, 2017
• Study Completion (Actual): October 5, 2017

Study Registration Dates

• First Submitted: August 8, 2017
• First Submitted That Met QC Criteria: August 8, 2017
• First Posted (Actual): August 10, 2017

Study Record Updates

• Last Update Posted (Actual): January 5, 2018
• Last Update Submitted That Met QC Criteria: January 3, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Branebrutinib
• Other Study ID Numbers: IM014-016; 2017-002706-12 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes