NCT03142165CompletedPhase 1
A Randomized, Placebo-Controlled, Double-Blind, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986263 in Healthy Participants
Bristol-Myers Squibb1 site in 1 country33 target enrollmentStarted: May 11, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Adverse Events (AE)
Study Overview
Brief Summary
The purpose of this study is to assess the safety and tolerability of BMS-986263 in healthy volunteers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy participants as determined by no clinically significant deviation from normal in medical history, physical exam, ECGs, and clinical laboratory determinations
- •Weight within the range of ≥60 and ≤90 kg
- •Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug
- •WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-986263 (21 days), plus 5 half-lives of BMS-986263 (7.5 days) plus 30 days (duration of ovulatory cycle) for a total of 90 days post-treatment completion
- •Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-986263 (21 days) plus 5 half-lives of BMS-986263 (7.5 days) plus the duration of sperm turnover (90 days) for a total of 118.5 days post-treatment completion. In addition, male participants must be willing to refrain from sperm donation during this time. Azoospermic males are exempt from contraceptive requirements
Exclusion Criteria
- •History or evidence of active infection and/or febrile illness within 7 days of Study Day 1 (e.g., bronchopulmonary, urinary, gastrointestinal, etc.)
- •History of serious bacterial, fungal, or viral infections that let to hospitalization and IV antibiotic treatment within 90 days prior to screening, or any recent serious infection requiring antibiotic treatment within 30 days of Study Day 1
- •History of recurrent or chronic sinusitis, bronchitis, pneumonia, urinary tract infection, or skin infection (recurrent or chronic infection is defined as ≥2 episodes within a 6 month period)
- •Active herpes infection, including herpes simplex 1 and 2 and herpes zoster (demonstrated on physical examination and/or medical history)
- •History of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- •Presence of active tuberculosis (TB), latent TB, or inadequately treated latent or active TB
- •Other protocol defined inclusion/exclusion criteria could apply
Arms & Interventions
BMS-986263
Experimental
Intervention: BMS-986263 (Drug)
BMS-986263
Experimental
Intervention: Diphenhydramine (Drug)
BMS-986263
Experimental
Intervention: Famotidine (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Other)
Placebo
Placebo Comparator
Intervention: Diphenhydramine (Drug)
Placebo
Placebo Comparator
Intervention: Famotidine (Drug)
Outcomes
Primary Outcomes
Adverse Events (AE)
Time Frame: 28 days
measured by incidences
Abnormalities in clinical laboratory tests
Time Frame: 28 days
measured by incidences
Serious Adverse Events (SAE)
Time Frame: 30 days
measured by incidences
Infusion related reactions
Time Frame: 28 days
measured by incidences
Abnormal electrocardiogram measurements
Time Frame: 28 days
measured by incidences
Abnormal vital sign measurements
Time Frame: 28 days
measured by incidences
Physical examination abnormalities
Time Frame: 28 days
measured by incidences
Secondary Outcomes
- T-HALF(28 days)
- Cmax(28 days)
- CLT(28 days)
- AUC(0-T)(28 days)
- Tmax(28 days)
- AI_AUC(28 days)
- Ctrough(28 days)
- T-HALFeff_AUC(28 days)
- Comparison of pharmacokinetic (PK) parameters in non-Japanese versus Japanese patients(28 days)
- AUC(TAU)(28 days)
Investigators
Study Sites (1)
Loading locations...
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