Safety Study of BMS-986202 in Healthy Subjects and to Treat Psoriasis

Sponsor
Bristol-Myers Squibb
Study ID
NCT02763969
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • BMS-986202 — DRUG
  • Placebo — DRUG
  • Interferon alpha-2a recombinant — DRUG
  • Famotidine — DRUG
  • Ustekinumab — DRUG

Study Details

The purpose of this study is to establish if BMS-986202 is safe and effective at treating autoimmune diseases such as psoriasis. BMS-986202 which has shown some promise in preclinical studies for inhibiting autoimmune conditions such as psoriasis. This study will be the first time this drug is given to humans.

Key Dates

Start date
May 18, 2016
Status verified
Jul 2017
Primary completion
Dec 15, 2016
Completion
Dec 15, 2016

Study Design

Enrollment
357 participants (actual)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Single Ascending Dose
    BMS-986202 or Placebo specified dose on specified days
  • Experimental: Part B: Multiple Ascending Dose
    BMS-986202 or Placebo + Interferon alpha-2a recombinant specified dose on specified days
  • Experimental: Part C: Multiple Ascending Dose-Japanese descent
    BMS-986202 or Placebo specified dose on specified days in patients of Japanese descent
  • Experimental: Part D: Relative Bioavailability
    BMS-986202 (Liquid) or BMS-986202 (Capsule) + Famotidine specified dose on specified days
  • Experimental: Part E: Proof of Mechanism
    BMS-986202 or Placebo + Ustekinumab specified dose on specified days

Primary Outcome Measure

Safety of a single oral dose of BMS-986202 based on number of incidence of AEs, SAEs, AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations [ Time Frame: 4 weeks after the start of treatment ]

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