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



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 50
Updated:12/21/2016
Start Date:September 2016
End Date:November 2016

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

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).


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
We found this trial at
1
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Austin, Texas 78744
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Austin, TX
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