Effect of BMS-986165 on the Pharmacokinetics of Rosuvastatin
Study Details
Study Description
Brief Summary
The study is to assess the effect of coadministration of multiple doses of BMS-986165 on the systemic exposure of rosuvastatin in healthy participants.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BMS 986165 and Rosuvastatin
|
Drug: BMS-986165
Rosuvastatin on Day 1. BMS 986165 on Days 5-8 and Days 10-12. On Day 9, BMS 986165 coadministered with an oral dose of rosuvastatin.
Drug: Rosuvastatin
Rosuvastatin on Day 1. BMS 986165 on Days 5-8 and Days 10-12. On Day 9, BMS 986165 coadministered with an oral dose of rosuvastatin.
|
Outcome Measures
Primary Outcome Measures
- Cmax (Maximum observed plasma concentration) of Rosuvastatin. [Up to Day 13]
Measured by plasma concentration.
- AUC(0-T) (Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration) of Rosuvastatin. [Up to Day 13]
Measured by plasma concentration.
- AUC(INF) (Area under the plasma concentration-time curve from time zero extrapolated to infinite time) of Rosuvastatin. [Up to Day 13]
Measured by plasma concentration.
Secondary Outcome Measures
- Number of Subjects with Deaths. [Up till 30 days after discontinuation]
Measured by investigator assessment.
- Number of Subjects with Serious Adverse Events. [Up till 30 days after discontinuation]
Measured by investigator assessment.
- Number of Subjects with Adverse Events. [Up till 30 days after discontinuation]
Measured by investigator assessment.
- Number of subjects with Adverse Events Leading to Discontinuation. [Up till 30 days after discontinuation]
Measured by investigator assessment.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Signed Informed Consent
-
Healthy male and female participants (not of childbearing potential) as determined by no clinically significant deviation from normal in medical history, physical exam, ECGs, and clinical laboratory determinations
-
Subjects with body mass index of 18 to 32 kg/m2, inclusive.
-
Women participants must have documented proof that they are not of childbearing potential.
-
Men who are sexually active with WOCBP must agree to follow instructions for method(s) of highly effective contraception for the duration of study treatment(s) plus 5 half-lives of BMS-986165 (4 days) plus 90 days (duration of sperm turnover) for a total of 94 days of post BMS-986165 treatment. In addition, male participants must be willing to refrain from sperm donation during this time.
Exclusion Criteria:
-
History of allergy to BMS-986165, rosuvastatin, or related compounds, of myalgia or rhabdomyolysis while taking rosuvastatin or related compounds or any other drug allergy
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Any significant acute or chronic medical illness, active TB requiring treatment or documented latent TB within the previous 3 years, current or recent gastrointestinal disease, current or recent history of nausea, vomiting, constipation or irregular bowel movement
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History of chronic headaches, syncope, orthostatic instability, or recurrent dizziness, biliary disorders, drug-induced acne or rash, fibromyalgia, neutropenia or thrombocytopenia
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Smokers who currently smoke, recent drug or alcohol abuse, blood transfusion within 4 weeks of study treatment administration, current skin findings that could interfere with the interpretation of study
Other protocol defined inclusion/exclusion criteria could apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | PPD Phase I Clinic | Austin | Texas | United States | 78744 |
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.- IM011-015