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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-11

Study Completion Date

2017-11-29

Brief Summary

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

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Detailed Description

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Conditions

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Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BMS-986263

Group Type EXPERIMENTAL

BMS-986263

Intervention Type DRUG

3 weekly doses of 90 mg infused intravenous administration

Diphenhydramine

Intervention Type DRUG

50 mg intravenous administration

Famotidine

Intervention Type DRUG

20 mg intravenous administration

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Diphenhydramine

Intervention Type DRUG

50 mg intravenous administration

Famotidine

Intervention Type DRUG

20 mg intravenous administration

Interventions

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BMS-986263

3 weekly doses of 90 mg infused intravenous administration

Intervention Type DRUG

Placebo

Intervention Type OTHER

Diphenhydramine

50 mg intravenous administration

Intervention Type DRUG

Famotidine

20 mg intravenous administration

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes