NCT03939702

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2019

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

May 2, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2019

Completed
Last Updated

October 4, 2019

Status Verified

August 1, 2019

Enrollment Period

2 months

First QC Date

May 2, 2019

Last Update Submit

October 2, 2019

Conditions

Thrombosis

Outcome Measures

Primary Outcomes (16)

  • 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 Outcomes (6)

  • Asess the Incidence of AEs of a single oral dose of 200 mg [14C] BMS-986177

    Day 1-12

  • Asess the Incidence of SAEs of a single oral dose of 200 mg [14C] BMS-986177

    Day 1-12

  • Asess the Incidence of AEs leading to discontinuation of a single oral dose of 200 mg [14C] BMS-986177

    Day 1-12

  • Assess the vital signs of a subject dosed with single oral dose of 200 mg [14C] BMS-986177

    Day 1-12

  • Assess the ECGs of subjects dosed with single oral dose of 200 mg [14C] BMS-986177

    Day 1-12

  • +1 more secondary outcomes

Study Arms (2)

Non-Bile Collection

ACTIVE COMPARATOR

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

Bile Collection

ACTIVE COMPARATOR

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

Interventions

BMS-986177DRUG

An orally administered anticoagulant to prevent and treat thromboembolic events

Bile CollectionNon-Bile Collection

Eligibility Criteria

Age18 Years - 50 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsBorn male
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical Research Unit, Inc.

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Conditions

Thrombosis

Interventions

milvexian

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2019

First Posted

May 7, 2019

Study Start

May 2, 2019

Primary Completion

July 11, 2019

Study Completion

July 11, 2019

Last Updated

October 4, 2019

Record last verified: 2019-08

Locations

US(1)