A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986263 in Healthy Participants
- Conditions
- Fibrosis
- Interventions
- Registration Number
- NCT03142165
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to assess the safety and tolerability of BMS-986263 in healthy volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - BMS-986263 Diphenhydramine - BMS-986263 BMS-986263 - Placebo Diphenhydramine - BMS-986263 Famotidine - Placebo Famotidine -
- Primary Outcome Measures
Name Time Method Abnormalities in clinical laboratory tests 28 days measured by incidences
Serious Adverse Events (SAE) 30 days measured by incidences
Infusion related reactions 28 days measured by incidences
Abnormal electrocardiogram measurements 28 days measured by incidences
Abnormal vital sign measurements 28 days measured by incidences
Physical examination abnormalities 28 days measured by incidences
Adverse Events (AE) 28 days measured by incidences
- Secondary Outcome Measures
Name Time Method Comparison of pharmacokinetic (PK) parameters in non-Japanese versus Japanese patients 28 days Investigation of population specific differences in PK
Cmax 28 days Maximum observed plasma concentration
CLT 28 days Total body clearance after IV dose
AUC(0-T) 28 days Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration
Tmax 28 days Time of maximum observed plasma concentration
AI_AUC 28 days Accumulation Index, the ratio of AUC(TAU) at steady-state to that after the first dose (Day 15 only)
Ctrough 28 days Trough observed plasma concentration
T-HALFeff_AUC 28 days Effective elimination half-life that explains the degree of accumulation observed for AUC(TAU) (Day 15 only)
AUC(TAU) 28 days Area under the concentration-time curve in one dosing interval (multiple dose only)
T-HALF 28 days Terminal phase half-life
Trial Locations
- Locations (1)
Wcct Global, Llc
🇺🇸Cypress, California, United States