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Effect of BMS-986165 on the Pharmacokinetics of Rosuvastatin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03044873
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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
Autoimmune Diseases Inflammatory Diseases Drug: BMS-986165 Drug: Rosuvastatin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of BMS-986165 on the Pharmacokinetics of Rosuvastatin
Actual Study Start Date : February 2, 2017
Actual Primary Completion Date : March 14, 2017
Actual Study Completion Date : March 27, 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Cmax (Maximum observed plasma concentration) of Rosuvastatin. [ Time Frame: Up to Day 13 ]
    Measured by plasma concentration.

  2. AUC(0-T) (Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration) of Rosuvastatin. [ Time Frame: Up to Day 13 ]
    Measured by plasma concentration.

  3. AUC(INF) (Area under the plasma concentration-time curve from time zero extrapolated to infinite time) of Rosuvastatin. [ Time Frame: Up to Day 13 ]
    Measured by plasma concentration.


Secondary Outcome Measures :
  1. Number of Subjects with Deaths. [ Time Frame: Up till 30 days after discontinuation ]
    Measured by investigator assessment.

  2. Number of Subjects with Serious Adverse Events. [ Time Frame: Up till 30 days after discontinuation ]
    Measured by investigator assessment.

  3. Number of Subjects with Adverse Events. [ Time Frame: Up till 30 days after discontinuation ]
    Measured by investigator assessment.

  4. Number of subjects with Adverse Events Leading to Discontinuation. [ Time Frame: Up till 30 days after discontinuation ]
    Measured by investigator assessment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Signed Informed Consent
  2. 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
  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 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:

  1. 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
  2. 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
  3. History of chronic headaches, syncope, orthostatic instability, or recurrent dizziness, biliary disorders, drug-induced acne or rash, fibromyalgia, neutropenia or thrombocytopenia
  4. 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044873


Locations
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United States, Texas
PPD Phase I Clinic
Austin, Texas, United States, 78744
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03044873    
Other Study ID Numbers: IM011-015
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: April 17, 2017
Last Verified: April 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Autoimmune Diseases
Immune System Diseases
BMS-986165
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Dermatologic Agents
Protein Kinase Inhibitors