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

Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03142165
• Other study ID #: IM025-001
• Status: Completed
• Phase: Phase 1
• First received: May 3, 2017
• Last updated: January 10, 2018
• Start date: May 11, 2017
• Est. completion date: November 29, 2017

Study information

• Verified date: January 2018
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 29, 2017
• Est. primary completion date: November 29, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis

Intervention

Drug:
• BMS-986263
3 weekly doses of 90 mg infused intravenous administration

Other:
• Placebo
Placebo

Drug:
• Diphenhydramine
50 mg intravenous administration
• Famotidine
20 mg intravenous administration

Locations

Country	Name	City	State
United States	Wcct Global, Llc	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events (AE)	measured by incidences	28 days
Primary	Serious Adverse Events (SAE)	measured by incidences	30 days
Primary	Infusion related reactions	measured by incidences	28 days
Primary	Abnormalities in clinical laboratory tests	measured by incidences	28 days
Primary	Abnormal vital sign measurements	measured by incidences	28 days
Primary	Abnormal electrocardiogram measurements	measured by incidences	28 days
Primary	Physical examination abnormalities	measured by incidences	28 days
Secondary	Cmax	Maximum observed plasma concentration	28 days
Secondary	Tmax	Time of maximum observed plasma concentration	28 days
Secondary	AUC(0-T)	Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration	28 days
Secondary	AUC(TAU)	Area under the concentration-time curve in one dosing interval (multiple dose only)	28 days
Secondary	T-HALF	Terminal phase half-life	28 days
Secondary	CLT	Total body clearance after IV dose	28 days
Secondary	AI_AUC	Accumulation Index, the ratio of AUC(TAU) at steady-state to that after the first dose (Day 15 only)	28 days
Secondary	T-HALFeff_AUC	Effective elimination half-life that explains the degree of accumulation observed for AUC(TAU) (Day 15 only)	28 days
Secondary	Ctrough	Trough observed plasma concentration	28 days
Secondary	Comparison of pharmacokinetic (PK) parameters in non-Japanese versus Japanese patients	Investigation of population specific differences in PK	28 days

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form