A Randomized, Double Blind Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Subjects

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo matching BMS-986166; Drug: BMS-986166

Study type: Interventional

Funder types: Industry

Identifiers

NCT02790125

IM018-001

Details and patient eligibility

About

The primary purpose of this study is to determine if single doses of BMS-986166 are safe and well tolerated in healthy male subjects and female subjects of non-childbearing potential.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Healthy female subjects of non-childbearing potential or male subjects as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations
• Ages 18 to 55 years
• Female subjects must provide documentation of an acceptable method of surgical sterilization or meet the protocol criteria for menopause

Exclusion Criteria:

• Any acute or chronic medical illness judged to be clinically significant by the Investigator and/or Sponsor medical monitor
• Any acute or chronic bacterial, fungal or viral infection, including tuberculosis, HIV, hepatitis B or hepatitis C, as defined in the protocol
• History of heart disease, neurological disease, eye disorders or gastrointestinal disorders or surgery (including cholecystectomy)
• Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs or clinical laboratory tests
• Smoking or nicotine use, drug or alcohol abuse within 6 months of starting the study

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 5 patient groups

Dose Panel 1

Experimental group

Description:

BMS-986166 or Placebo matching BMS-986166 Single oral dose of solution as specified

Treatment:

Drug: BMS-986166

Drug: Placebo matching BMS-986166

Dose Panel 2

Experimental group

Description:

BMS-986166 or Placebo matching BMS-986166 Single oral dose of solution as specified

Treatment:

Drug: BMS-986166

Drug: Placebo matching BMS-986166

Dose Panel 3

Experimental group

Description:

BMS-986166 or Placebo matching BMS-986166 Single oral dose of solution as specified

Treatment:

Drug: BMS-986166

Drug: Placebo matching BMS-986166

Dose Panel 4

Experimental group

Description:

BMS-986166 or Placebo matching BMS-986166 Multiple ascending solid dose formulation as specified

Treatment:

Drug: BMS-986166

Drug: Placebo matching BMS-986166

Dose Panel 5a/b/c

Experimental group

Description:

BMS-986166 Single oral solid dose formulation under fasting/fed/fasting with famotidine conditions

Treatment:

Drug: BMS-986166