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

Bristol-Myers Squibb (BMS)

Status and phase: Withdrawn; Phase 1

Conditions: Healthy

Treatments: Drug: BMS-986141 Form B tablet (low dose); Drug: BMS-986141 Form A Tablet; Drug: BMS-986141 Form B tablet (high dose)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03035734

2016-001031-13 (EudraCT Number)

CV006-023

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 4 patient groups

A

Active Comparator group

Description:

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

Treatment:

Drug: BMS-986141 Form A Tablet

B

Experimental group

Description:

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

Treatment:

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

C

Experimental group

Description:

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

Treatment:

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

D

Experimental group

Description:

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

Treatment:

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