NCT03362437

Brief Summary

Assess the pharmacokinetics (fasting and fed), safety, and tolerability of BMS-986177 following oral dosing of Form A and Form B

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2017

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

Study Start

First participant enrolled

November 15, 2017

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 5, 2017

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2017

Completed
Last Updated

March 14, 2018

Status Verified

March 1, 2018

Enrollment Period

1 month

First QC Date

November 30, 2017

Last Update Submit

March 13, 2018

Conditions

Thrombosis

Outcome Measures

Primary Outcomes (3)

  • Maximum observed plasma concentration (Cmax)

    Measured by plasma concentration

    Up to 3 days

  • AUC from time zero to time of last quantifiable concentration (AUC(0-T))

    Measured by plasma concentration

    Up to 3 days

  • AUC from time zero extrapolated to infinite time (AUC(INF))

    Measured by plasma concentration

    Up to 3 days

Secondary Outcomes (5)

  • Incidence of Adverse Events (AEs)

    Up to 12 days

  • Incidence of Serious Adverse Events (SAEs)

    Up to 30 days

  • Number of participants with electrocardiogram abnormalities

    Up to 12 days

  • Number of participants with physical examination abnormalities

    Up to 12 days

  • Number of participants with clinical laboratory abnormalities

    Up to 12 days

Study Arms (3)

Treatment A

EXPERIMENTAL

Receive 200 mg BMS-986177 Form A without food

Drug: BMS-986177

Treatment B

EXPERIMENTAL

Receive 200 mg BMS-986177 Form B without food

Drug: BMS-986177

Treatment C

EXPERIMENTAL

Receive 200 mg BMS-986177 Form B with food

Drug: BMS-986177

Interventions

BMS-986177DRUG

Form A

Treatment A

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index 18.0 to 32.0 kg/m2, inclusive
  • Women must not be of childbearing potential (cannot become pregnant)

You may not qualify if:

  • Any significant acute or chronic medical illness
  • Head injury in the last 2 years
  • History of bleeding disorder including rectal bleeding (ie, hemorrhoids), spontaneous nosebleeds, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quotient Clinical

Ruddington, Nottingham, NG11 6JS, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Thrombosis

Interventions

milvexian

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Bristol-Myers Squibb

    Briston-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2017

First Posted

December 5, 2017

Study Start

November 15, 2017

Primary Completion

December 28, 2017

Study Completion

December 28, 2017

Last Updated

March 14, 2018

Record last verified: 2018-03

Locations

GB(1)