A Study to Evaluate the Effect of Co-administration of Itraconazole or Diltiazem on the Pharmacokinetics of BMS-986177 in Healthy Subjects
Study Details
Study Description
Brief Summary
The study is being conducted to assess the effects of co-administration of itraconazole or diltiazem, respectively, on the pharmacokinetic (PK) parameters Cmax, AUC(INF), and AUC(0-T) of BMS-986177
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BMS-986177 and Itraconazole Single dose BMS-986177 on day 1 followed by Itraconazole and BMS-986177 on specified days |
Drug: BMS-986177
Drug: Itraconazole
|
| Experimental: BMS-986177 and Diltiazem Single dose BMS-986177 on day 1 followed by Diltiazem ER and BMS-986177 on specified days |
Drug: BMS-986177
Drug: Diltiazem ER
|
Outcome Measures
Primary Outcome Measures
- Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC (0-T)) of BMS-986177 [Days 1-12]
- Maximum observed concentration (Cmax) [Days 1-12]
- Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) [Days 1-12]
Secondary Outcome Measures
- 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 scheduled visit occurs at a later time.]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Signed Informed Consent
-
Target population: Healthy subjects as determined by medical history, surgical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory determinations.
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Subjects with body mass index of 18 to 30 kg/m2, inclusive
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Men, and women of nonchildbearing potential. Women must have documented proof that they are not of childbearing potential and are not breast feeding
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Males who are sexually active with women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half-lives of the study drug (3 days) plus 90 days (duration of sperm turnover) for a total of 92 days for subjects in the BMS-986177 - diltiazem sequence, and 99 days for subjects in the BMS-986177 - itraconazole sequence.
Exclusion Criteria:
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Any significant acute or chronic medical illness, including hepatic disease, or any other condition listed as a contraindication in the diltiazem or itraconazole package inserts.
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Evidence of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising or thrombus formation.
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History of chronic constipation, GI disease, arrhythmias, sinus bradycardia, significant head injury, dizziness or headaches, hemophilia, Rosenthal syndrome, or FX1a deficiency or other coagulopathies, systemic lupus erythematosus.
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Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population
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History of allergy to BMS-986177, itraconazole, diltiazem, or related compounds.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CV010-005