Safety Study of BMS-986165 in Healthy Subjects and to Treat Psoriasis

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: BMS-986165; Drug: Famotidine; Drug: Interferon alpha-2a recombinant; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02534636

IM011-002

Details and patient eligibility

About

The purpose of this study is to establish if BMS-986165 is safe and effective at treating autoimmune diseases. BMS-986165 which has shown some promise in preclinical studies for inhibiting autoimmune conditions. This study will be the first time this drug is given to humans, and will be conducted entirely in healthy subjects. It will be run in 4 Parts. Part A will investigate single oral doses of drug. Part B will investigate giving the drug daily for 14 days. Part C will investigate daily doses for 14 days in healthy volunteers with Japanese decent. Part D will investigate whether food, stomach acidity or giving the drug in a capsule makes a difference to the safety and potential use of this drug.

Enrollment: 140 patients

Sex: All

Ages: 18 to 70 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 Male and Female participants
• 18 to 50 years of age (Parts A-D)

Exclusion Criteria:

• Participants that had recent infections
• Participants with low blood pressure or increased heart rate
• Participants with any chronic health related problems
• Participants with active cancer within the last 5 years
• Participants with any other major medical illness

Trial design

140 participants in 4 patient groups

Part A: Single ascending dose

Experimental group

Description:

BMS-986165 or Placebo specified dose on specified days

Treatment:

Other: Placebo

Drug: BMS-986165

Part B: Multiple ascending dose

Experimental group

Description:

BMS-986165 or Placebo + Interferon alpha-2a recombinant specified dose on specified days

Treatment:

Other: Placebo

Drug: BMS-986165

Drug: Interferon alpha-2a recombinant

Part C: Multiple ascending dose

Experimental group

Description:

BMS-986165 or Placebo specified dose on specified days

Treatment:

Other: Placebo

Drug: BMS-986165

Part D: Relative Bioavailability

Experimental group

Description:

BMS-986165 (Liquid) + BMS-986165 (Capsule) + Famotidine specified dose on specified days

Treatment:

Drug: BMS-986165

Drug: Famotidine