Evaluate the Bioavailability Between 2 BMS-986141 Formulations in Healthy Participants

Phase 1

Withdrawn

• Conditions: Healthy
• Interventions: Drug: BMS-986141 Form B tablet (low dose); Drug: BMS-986141 Form A Tablet; Drug: BMS-986141 Form B tablet (high dose)

• Registration Number: NCT03035734
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-23
• Study Start: 2017-01-25
• Study First Submitted QC: 2017-01-26
• Study First Posted: 2017-01-30
• Primary Completion: 2017-02-07
• Study Completion: 2017-02-07
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-21
• Last Update Posted: 2018-03-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• other exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B	BMS-986141 Form B tablet (low dose)	Single oral dose BMS-986141 Form B tablet (low-dose) under fasting conditions
A	BMS-986141 Form A Tablet	Single oral dose BMS-986141 Form A tablet under fasting conditions
C	BMS-986141 Form B tablet (high dose)	Single oral dose BMS-986141 Form B tablet (high-dose) under fasting conditions
D	BMS-986141 Form B tablet (high dose)	Single oral dose BMS-986141 Form B tablet (high-dose) under fed conditions

Primary Outcome Measures

Name	Time	Method
Evaluate the bioavailability between BMS-986141 Form B tablet compared to the Form A reference tablet	4 weeks

Secondary Outcome Measures

Name	Time	Method
Further characterize safety and tolerability of BMS-986141 by assessing adverse events and other physical assessments throughout study conduct	4 weeks