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

Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03939702
• Other study ID #: CV010-036
• Status: Completed
• Phase: Phase 1
• Start date: May 2, 2019
• Est. completion date: July 11, 2019

Study information

• Verified date: August 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: July 11, 2019
• Est. primary completion date: July 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Thrombosis

Intervention

Drug:
• BMS-986177
An orally administered anticoagulant to prevent and treat thromboembolic events

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit, Inc.	Madison	Wisconsin

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	Assess PK Cmax of a dose of [14C]BMS-986177	Cmax	Day 1-12
Primary	Assess PK AUC(INF) of a dose of [14C]BMS-986177	AUC(INF)	Day 1-12
Primary	Assess PK AUC(0-T) of a dose of [14C]BMS-986177	AUC(0-T)	Day 1-12
Primary	Assess PK Tmax of a dose of [14C]BMS-986177	Tmax	Day 1-12
Primary	Assess PK T-HALF of a dose of [14C]BMS-986177	T-HALF	Day 1-12
Primary	Assess PK CL/F of a dose of [14C]BMS-986177		Day 1-12
Primary	Assess PK Vz/F of a dose of [14C]BMS-986177	Vz/F	Day 1-12
Primary	Assess PK AUC of a dose of [14C]BMS-986177	AUC(BMS-986177)	Day 1-12
Primary	Assess PK AUC(TRA) of a dose of [14C]BMS-986177	AUC(TRA)	Day 1-12
Primary	Assess PK Plasma AUC(TRA) of a dose of [14C]BMS-986177	Plasma AUC(TRA)	Day 1-12
Primary	Assess PK Blood AUC(TRA) of a dose of [14C]BMS-986177	Blood AUC(TRA)	Day 1-12
Primary	Assess the CLR of [14C]BMS-986177	CLR	Day 1-12
Primary	Assess the %UR of [14C]BMS-986177	%UR	Day 1-12
Primary	Assess the %FE of [14C]BMS-986177	%FE	Day 1-12
Primary	Assess the %BE of [14C]BMS-986177	%BE (if applicable)	Day 1-12
Primary	Assess the %Total recovery of [14C]BMS-986177	%Total recovery	Day 1-12
Secondary	Asess the Incidence of AEs of a single oral dose of 200 mg [14C] BMS-986177	Incidence of AEs	Day 1-12
Secondary	Asess the Incidence of SAEs of a single oral dose of 200 mg [14C] BMS-986177	Incidence of SAEs	Day 1-12
Secondary	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
Secondary	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
Secondary	Assess the ECGs of subjects dosed with single oral dose of 200 mg [14C] BMS-986177	ECG physical examinations	Day 1-12
Secondary	Assess the clinical lab tests of a single oral dose of 200 mg [14C] BMS-986177	Results of Clinical laboratory tests	Day 1-12