A Study to Evaluate the Effect of Diltiazem on the Pharmacokinetics (PK) of BMS-986141 in Healthy Subjects

Ischemic Stroke Clinical Trial

Official title:

An Open-Label, Single-Sequence Study to Evaluate the Effect of Diltiazem on the Single-Dose Pharmacokinetics of BMS-986141 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02922452
• Other study ID #: CV006-028
• Status: Completed
• Phase: Phase 1
• First received: September 30, 2016
• Last updated: December 19, 2016
• Start date: September 2016
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate the effect of dilitazem on the single-dose PK of BMS-986141 with parameters like Cmax, AUC(INF), and AUC(0-T).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Signed Informed Consent

2. Healthy men and women (not of child bearing potential) as determined by medical history, surgical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests including coagulation parameters.

3. Subjects with body mass index of 18 to 32 kg/m2, inclusive.

4. Women participants must have documented proof that they are not of childbearing potential.

5. Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-986141 plus 5 half-lives plus 90 days for a total of 100 days post-treatment completion.

Exclusion Criteria:

1. Acute or chronic medical illness, subjects with bleeding diathesis, gastrointestinal ulcer, hepatic disease.

2. History of nausea, diarrhoea, recent surgery, use of tobacco or nicotine containing products, drug or alcohol use, important arrhythmias, sinus bradycardia, chronic headaches, history of multiple events of dizziness, periodontal disease and recent blood donation.

3. Prior exposure to BMS-986141 or prothrombin complex, any investigational product or placebo within 4 weeks of study treatment start, any prescription or over the counter drugs except those cleared by BMS clinical monitor.

4. History of allergy to BMS-986141, dilitazem or any other significant drug allergy or adverse reaction to anticoagulants or antiplatelets.

5. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs, or clinical laboratory determinations beyond what is consistent with the target population

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Ischemic Stroke

Intervention

Drug:
• BMS-986141
Single dose BMS-986141 and Multiple doses of Dilitazem
• Dilitazem
Single dose BMS-986141 and Multiple doses of Dilitazem

Locations

Country	Name	City	State
United States	PPD Development	Austin	Texas

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	Maximum observed concentration (Cmax)		Days 1-21	No
Primary	Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))		Days 1-21	No
Primary	Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC (0-T))		Days 1-21	No
Secondary	Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and death		Screening- until 30 days after discontinuation of dosing or subject's participation in the study if the last]	Yes

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