Clinical trial NCT03142165: A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986263 in Healthy Participants
Official title: A Randomized, Placebo-Controlled, Double-Blind, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986263 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Fibrosis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-05-05
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this study is to assess the safety and tolerability of BMS-986263 in healthy volunteers.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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

Primary outcomes:
measure: Adverse Events (AE)
timeFrame: 28 days
measure: Serious Adverse Events (SAE)
timeFrame: 30 days
measure: Infusion related reactions
timeFrame: 28 days
measure: Abnormalities in clinical laboratory tests
timeFrame: 28 days
measure: Abnormal vital sign measurements
timeFrame: 28 days
measure: Abnormal electrocardiogram measurements
timeFrame: 28 days
measure: Physical examination abnormalities
timeFrame: 28 days
Secondary outcomes:
measure: Cmax
timeFrame: 28 days
measure: Tmax
timeFrame: 28 days
measure: AUC(0-T)
timeFrame: 28 days
measure: AUC(TAU)
timeFrame: 28 days
measure: T-HALF
timeFrame: 28 days
measure: CLT
timeFrame: 28 days
measure: AI_AUC
timeFrame: 28 days
measure: T-HALFeff_AUC
timeFrame: 28 days
measure: Ctrough
timeFrame: 28 days
measure: Comparison of pharmacokinetic (PK) parameters in non-Japanese versus Japanese patients
timeFrame: 28 days
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Wcct Global, Llc
state: California
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: