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

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

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

Study Overview

• Status: Completed
• Conditions: Fibrosis
• Intervention / Treatment: Other: Placebo; Drug: BMS-986263; Drug: Diphenhydramine; Drug: Famotidine

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
      • WCCT Global, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2017
• Primary Completion (Actual): November 29, 2017
• Study Completion (Actual): November 29, 2017

Study Registration Dates

• First Submitted: May 3, 2017
• First Submitted That Met QC Criteria: May 3, 2017
• First Posted (Actual): May 5, 2017

Study Record Updates

• Last Update Posted (Actual): January 12, 2018
• Last Update Submitted That Met QC Criteria: January 10, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Hypnotics and Sedatives; Anesthetics, Local; Anti-Ulcer Agents; Anti-Allergic Agents; Sleep Aids, Pharmaceutical; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Histamine H2 Antagonists; Diphenhydramine; Promethazine; Famotidine
• Other Study ID Numbers: IM025-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No