A Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Target Engagement of BMS-986147 in Healthy Subjects

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BMS-986147; Drug: Placebo matching BMS-986147

Study type: Interventional

Funder types: Industry

Identifiers

NCT02293629

IM008-003

Details and patient eligibility

About

This is the first clinical study with the BMS-986147 compound in healthy subjects. The purpose of this study is to guide the dose range and dose frequency for future studies with BMS-986147 and will provide guidelines for selection of a potentially effective dose in patients.

Enrollment: 8 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Healthy men and women, ages 18 to 45 years
• Subjects must not have clinically significant deviation from normal: medical history, physical examination, ECGs and laboratory evaluations
• Women of child bearing potential are eligible for enrollment.
• Women must have a negative pregnancy test

Exclusion Criteria:

• Evidence of organ dysfunction
• Any significant acute or chronic medical illness
• Inability to: tolerate oral medications, be venipunctured

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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8 participants in 5 patient groups, including a placebo group

A1: BMS-986147 or Placebo matching BMS-986147

Placebo Comparator group

Description:

Single oral dose as specified

Treatment:

Drug: BMS-986147

Drug: Placebo matching BMS-986147

A2: BMS-986147 or Placebo matching BMS-986147

Placebo Comparator group

Description:

Single oral dose as specified

Treatment:

Drug: BMS-986147

Drug: Placebo matching BMS-986147

A3: BMS-986147 or Placebo matching BMS-986147

Placebo Comparator group

Description:

Single oral dose as specified

Treatment:

Drug: BMS-986147

Drug: Placebo matching BMS-986147

B1: BMS-986147 or Placebo matching BMS-986147

Active Comparator group

Description:

Daily oral dose as specified

Treatment:

Drug: BMS-986147

Drug: Placebo matching BMS-986147

B2: BMS-986147 or Placebo matching BMS-986147

Active Comparator group

Description:

Daily oral dose as specified

Treatment:

Drug: BMS-986147

Drug: Placebo matching BMS-986147