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

NCT02534636 | Completed Phase 1

• 1 other identifier: IM011-002
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (4)

• 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

  Adverse Event (AE), Serious adverse event (SAE)

  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

• 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

• 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

Secondary Outcomes (4)

• 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

• 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

Study Arms (4)

Part A: Single ascending dose

EXPERIMENTAL

BMS-986165 or Placebo specified dose on specified days

Drug: BMS-986165; Other: Placebo

Part B: Multiple ascending dose

EXPERIMENTAL

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

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

Part C: Multiple ascending dose

EXPERIMENTAL

BMS-986165 or Placebo specified dose on specified days

Drug: BMS-986165; Other: Placebo

Part D: Relative Bioavailability

EXPERIMENTAL

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

Drug: BMS-986165; Drug: Famotidine

Interventions

BMS-986165 DRUG

Part A: Single ascending dose; Part B: Multiple ascending dose; Part C: Multiple ascending dose; Part D: Relative Bioavailability

Interferon alpha-2a recombinant DRUG

Part B: Multiple ascending dose

Famotidine DRUG

Part D: Relative Bioavailability

Placebo OTHER

Part A: Single ascending dose; Part B: Multiple ascending dose; Part C: Multiple ascending dose

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Melbourne, Victoria, 3004, Australia

Location

Related Publications (1)

• Catlett IM, Aras U, Hansen L, Liu Y, Bei D, Girgis IG, Murthy B. First-in-human study of deucravacitinib: A selective, potent, allosteric small-molecule inhibitor of tyrosine kinase 2. Clin Transl Sci. 2023 Jan;16(1):151-164. doi: 10.1111/cts.13435. Epub 2022 Nov 22.

  PMID: 36325947 DERIVED

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Interventions

deucravacitinib; Interferon alpha-2; Famotidine

Intervention Hierarchy (Ancestors)

Interferon-alpha; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bristol Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2015
• First Posted: August 27, 2015
• Study Start: October 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 28, 2016

Record last verified: 2016-10

Locations

AU (1)