NCT03035734

Brief Summary

Open label, randomized, 4-period crossover study with single doses of BMS-986141 given to healthy female subjects of non-childbearing potential and healthy males.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2017

Status
withdrawn

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

December 23, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

January 25, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 30, 2017

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2017

Completed
Last Updated

March 23, 2018

Status Verified

March 1, 2018

Enrollment Period

13 days

First QC Date

December 23, 2016

Last Update Submit

March 21, 2018

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Evaluate the bioavailability between BMS-986141 Form B tablet compared to the Form A reference tablet

    4 weeks

Secondary Outcomes (1)

  • Further characterize safety and tolerability of BMS-986141 by assessing adverse events and other physical assessments throughout study conduct

    4 weeks

Study Arms (4)

A

ACTIVE COMPARATOR

Single oral dose BMS-986141 Form A tablet under fasting conditions

Drug: BMS-986141 Form A Tablet

B

EXPERIMENTAL

Single oral dose BMS-986141 Form B tablet (low-dose) under fasting conditions

Drug: BMS-986141 Form B tablet (low dose)

C

EXPERIMENTAL

Single oral dose BMS-986141 Form B tablet (high-dose) under fasting conditions

Drug: BMS-986141 Form B tablet (high dose)

D

EXPERIMENTAL

Single oral dose BMS-986141 Form B tablet (high-dose) under fed conditions

Drug: BMS-986141 Form B tablet (high dose)

Interventions

BMS-986141 Form A TabletDRUG

tablet

A
BMS-986141 Form B tablet (low dose)DRUG

tablet

B
BMS-986141 Form B tablet (high dose)DRUG

tablet

CD

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy participants as determined by no significant deviations in normal medical and surgical history and assessments
  • Body mass index 18.0 kg/m2 to 32.0 kg/m2
  • females must be of non-childbearing potential

You may not qualify if:

  • known bleeding or coagulation disorders
  • acute or chronic medical illness
  • history of nausea or chronic diarrhea that lasts over 4 weeks
  • history of periodontal disease or gingivitis which required treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR
0

Study Design

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

Study Record Dates

First Submitted

December 23, 2016

First Posted

January 30, 2017

Study Start

January 25, 2017

Primary Completion

February 7, 2017

Study Completion

February 7, 2017

Last Updated

March 23, 2018

Record last verified: 2018-03