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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: BMS-986165; Drug: Interferon alpha-2a recombinant; Drug: Famotidine; Other: Placebo

• Registration Number: NCT02534636
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-23
• Study First Submitted QC: 2015-08-26
• Study First Posted: 2015-08-27
• Study Start: 2015-10
• Status Verified: 2016-10
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Last Update Submitted: 2016-12-23
• Last Update Posted: 2016-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part C: Multiple ascending dose	BMS-986165	BMS-986165 or Placebo specified dose on specified days
Part B: Multiple ascending dose	Interferon alpha-2a recombinant	BMS-986165 or Placebo + Interferon alpha-2a recombinant specified dose on specified days
Part B: Multiple ascending dose	Placebo	BMS-986165 or Placebo + Interferon alpha-2a recombinant specified dose on specified days
Part C: Multiple ascending dose	Placebo	BMS-986165 or Placebo specified dose on specified days
Part D: Relative Bioavailability	BMS-986165	BMS-986165 (Liquid) + BMS-986165 (Capsule) + Famotidine specified dose on specified days
Part A: Single ascending dose	BMS-986165	BMS-986165 or Placebo specified dose on specified days
Part A: Single ascending dose	Placebo	BMS-986165 or Placebo specified dose on specified days
Part B: Multiple ascending dose	BMS-986165	BMS-986165 or Placebo + Interferon alpha-2a recombinant specified dose on specified days
Part D: Relative Bioavailability	Famotidine	BMS-986165 (Liquid) + BMS-986165 (Capsule) + Famotidine specified dose on specified days

Primary Outcome Measures

Name	Time	Method
Safety of a multiple oral dose of BMS-986165 based on number of incidence of AE, SAEs, AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations	Approximately 3 months
Safety of a single oral dose of BMS-986165 based on number of incidence of AE, SAEs, AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations	Approximately 3 months	Adverse Event (AE), Serious adverse event (SAE)
Tolerability of a multiple oral dose of BMS-986165 based on number of incidence of AE, SAEs, AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations	Approximately 3 months
Tolerability of a single oral dose of BMS-986165 based on number of incidence of AE, SAEs, AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations	Approximately 3 months

Secondary Outcome Measures

Name	Time	Method
Effect of BMS-986165 on electrocardiographic (ECG) parameters such as QRS interval in healthy subjects of any ethnic background (Parts A, B, C, D)	Approximately 3 months
Effect of BMS-986165 on electrocardiographic (ECG) parameters such as QTc interval in healthy subjects of any ethnic background (Parts A, B, C, D)	Approximately 3 months
Effect of BMS-986165 on electrocardiographic (ECG) parameters such as heart rate in healthy subjects of any ethnic background (Parts A, B, C, D)	Approximately 3 months
Effect of BMS-986165 on electrocardiographic (ECG) parameters such as PR interval in healthy subjects of any ethnic background (Parts A, B, C, D)	Approximately 3 months

Trial Locations

Locations (1)

Local Institution; 🇦🇺 Melbourne, Victoria, Australia