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

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ClinicalTrials.gov Identifier: NCT02534636
Recruitment Status : Completed
First Posted : August 27, 2015
Last Update Posted : December 28, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: BMS-986165 Drug: Interferon alpha-2a recombinant Drug: Famotidine Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986165 in Healthy Subjects and to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy of BMS-986165 in Subjects With Moderate to Severe Psoriasis
Study Start Date : October 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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



Primary Outcome Measures :
  1. 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 [ Time Frame: Approximately 3 months ]
    Adverse Event (AE), Serious adverse event (SAE)

  2. 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 [ Time Frame: Approximately 3 months ]
  3. 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 [ Time Frame: Approximately 3 months ]
  4. 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 [ Time Frame: Approximately 3 months ]

Secondary Outcome Measures :
  1. Effect of BMS-986165 on electrocardiographic (ECG) parameters such as heart rate in healthy subjects of any ethnic background (Parts A, B, C, D) [ Time Frame: Approximately 3 months ]
  2. Effect of BMS-986165 on electrocardiographic (ECG) parameters such as PR interval in healthy subjects of any ethnic background (Parts A, B, C, D) [ Time Frame: Approximately 3 months ]
  3. Effect of BMS-986165 on electrocardiographic (ECG) parameters such as QRS interval in healthy subjects of any ethnic background (Parts A, B, C, D) [ Time Frame: Approximately 3 months ]
  4. Effect of BMS-986165 on electrocardiographic (ECG) parameters such as QTc interval in healthy subjects of any ethnic background (Parts A, B, C, D) [ Time Frame: Approximately 3 months ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02534636


Locations
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Australia, Victoria
Local Institution
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02534636     History of Changes
Other Study ID Numbers: IM011-002
First Posted: August 27, 2015    Key Record Dates
Last Update Posted: December 28, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
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Famotidine
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Interferons
Interferon-alpha
Interferon alpha-2
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action