A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986263 in Healthy Participants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and tolerability of BMS-986263 in healthy volunteers.

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

Conditions
-----------------
Fibrosis

Intervention / Treatment
-----------------
* Drug: BMS-986263
* Other: Placebo
* Drug: Diphenhydramine
* Drug: Famotidine


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986263<br> | Drug: BMS-986263<br>* 3 weekly doses of 90 mg infused intravenous administration<br>Drug: Diphenhydramine<br>* 50 mg intravenous administration<br>Drug: Famotidine<br>* 20 mg intravenous administration<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Placebo<br>Drug: Diphenhydramine<br>* 50 mg intravenous administration<br>Drug: Famotidine<br>* 20 mg intravenous administration<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events (AE) | measured by incidences | 28 days | 
| Serious Adverse Events (SAE) | measured by incidences | 30 days | 
| Infusion related reactions | measured by incidences | 28 days | 
| Abnormalities in clinical laboratory tests | measured by incidences | 28 days | 
| Abnormal vital sign measurements | measured by incidences | 28 days | 
| Abnormal electrocardiogram measurements | measured by incidences | 28 days | 
| Physical examination abnormalities | measured by incidences | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum observed plasma concentration | 28 days | 
| Tmax | Time of maximum observed plasma concentration | 28 days | 
| AUC(0-T) | Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration | 28 days | 
| AUC(TAU) | Area under the concentration-time curve in one dosing interval (multiple dose only) | 28 days | 
| T-HALF | Terminal phase half-life | 28 days | 
| CLT | Total body clearance after IV dose | 28 days | 
| AI_AUC | Accumulation Index, the ratio of AUC(TAU) at steady-state to that after the first dose (Day 15 only) | 28 days | 
| T-HALFeff_AUC | Effective elimination half-life that explains the degree of accumulation observed for AUC(TAU) (Day 15 only) | 28 days | 
| Ctrough | Trough observed plasma concentration | 28 days | 
| Comparison of pharmacokinetic (PK) parameters in non-Japanese versus Japanese patients | Investigation of population specific differences in PK | 28 days |