Pharmacokinetic and Metabolism of [14^C] BMS-986177 in Healthy Male Participants

This is an ADME study. Human radiolabeled mass balance studies are performed as part of drug development to obtain information about the absorption, distribution, metabolism, and excretion (ADME) of a study treatment. The goals of human ADME studies include the assessment of absorption, distribution, routes and rates of excretion, mass balance, and metabolite profile and identification.

Study Overview

• Status: Completed
• Conditions: Thrombosis
• Intervention / Treatment: Drug: BMS-986177

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Covance Clinical Research Unit, Inc.

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Signed ICF
• Healthy Male
• Body mass index of 18.0 to 32.0 kg/m2, inclusive.
• Agreement to use approved contraception for 94 days post treatment
• Agreement to not donate sperm for 94 days post treatment

Exclusion Criteria:

• Acute or chronic illness
• GI disease current or recent
• History of dizziness or recurring headaches
• Head injury within last 2 years
• GI surgery
• History or evidence of abnormal bleeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Non-Bile Collection; On Day 1, all participants will receive a single oral solution dose of 200 mg [14C] BMS-986177 containing approximately 88 micro Ci of total radioactivity (TRA). Participants will remain in the clinical facility until at least Day 7 and will be discharged when release criteria are met or until Day 12	Drug: BMS-986177; An orally administered anticoagulant to prevent and treat thromboembolic events
Active Comparator: Bile Collection; On Day 1, all participants will receive a single oral solution dose of 200 mg [14C] BMS-986177 containing approximately 88 micro Ci of total radioactivity (TRA). Approximately 1 hour after study drug administration, an ND tube may be positioned in approximately 3 selected participants for collection of bile.Participants will remain in the clinical facility until at least Day 7 and will be discharged when release criteria are met or until Day 12	Drug: BMS-986177; An orally administered anticoagulant to prevent and treat thromboembolic events

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess PK Cmax of a dose of [14C]BMS-986177	Cmax	Day 1-12
Assess PK AUC(INF) of a dose of [14C]BMS-986177	AUC(INF)	Day 1-12
Assess PK AUC(0-T) of a dose of [14C]BMS-986177	AUC(0-T)	Day 1-12
Assess PK Tmax of a dose of [14C]BMS-986177	Tmax	Day 1-12
Assess PK T-HALF of a dose of [14C]BMS-986177	T-HALF	Day 1-12
Assess PK CL/F of a dose of [14C]BMS-986177		Day 1-12
Assess PK Vz/F of a dose of [14C]BMS-986177	Vz/F	Day 1-12
Assess PK AUC of a dose of [14C]BMS-986177	AUC(BMS-986177)	Day 1-12
Assess PK AUC(TRA) of a dose of [14C]BMS-986177	AUC(TRA)	Day 1-12
Assess PK Plasma AUC(TRA) of a dose of [14C]BMS-986177	Plasma AUC(TRA)	Day 1-12
Assess PK Blood AUC(TRA) of a dose of [14C]BMS-986177	Blood AUC(TRA)	Day 1-12
Assess the CLR of [14C]BMS-986177	CLR	Day 1-12
Assess the %UR of [14C]BMS-986177	%UR	Day 1-12
Assess the %FE of [14C]BMS-986177	%FE	Day 1-12
Assess the %BE of [14C]BMS-986177	%BE (if applicable)	Day 1-12
Assess the %Total recovery of [14C]BMS-986177	%Total recovery	Day 1-12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asess the Incidence of AEs of a single oral dose of 200 mg [14C] BMS-986177	Incidence of AEs	Day 1-12
Asess the Incidence of SAEs of a single oral dose of 200 mg [14C] BMS-986177	Incidence of SAEs	Day 1-12
Asess the Incidence of AEs leading to discontinuation of a single oral dose of 200 mg [14C] BMS-986177	Incidence of AEs leading to discontinuation	Day 1-12
Assess the vital signs of a subject dosed with single oral dose of 200 mg [14C] BMS-986177	results of vital sign examination	Day 1-12
Assess the ECGs of subjects dosed with single oral dose of 200 mg [14C] BMS-986177	ECG physical examinations	Day 1-12
Assess the clinical lab tests of a single oral dose of 200 mg [14C] BMS-986177	Results of Clinical laboratory tests	Day 1-12

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2019
• Primary Completion (Actual): July 11, 2019
• Study Completion (Actual): July 11, 2019

Study Registration Dates

• First Submitted: May 2, 2019
• First Submitted That Met QC Criteria: May 3, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Actual): October 4, 2019
• Last Update Submitted That Met QC Criteria: October 2, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis
• Other Study ID Numbers: CV010-036

Drug and device information, study documents

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