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A Study to Assess the Drug-drug Interaction of BMS-963272 and Rosuvastatin

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ClinicalTrials.gov Identifier: NCT04124003
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
Phase 1 study that assesses the effect of BMS-963272 on exposure of rosuvastatin in healthy participants

Condition or disease Intervention/treatment Phase
Healthy Participants Drug: rosuvastatin Drug: BMS-963272 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: An Open-label, Single-sequence, Drug-drug Interaction Study to Assess the Effect of BMS-963272 Coadministration on the Systemic Exposure of Rosuvastatin in Healthy Participants
Actual Study Start Date : October 8, 2019
Estimated Primary Completion Date : December 19, 2019
Estimated Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: rosuvastatin + BMS-963272 Drug: rosuvastatin
Specified dose on specified days

Drug: BMS-963272
Specified dose on specified days




Primary Outcome Measures :
  1. Maximum concentration (Cmax) [ Time Frame: up to Day 10 ]
  2. Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration AUC(0-T) [ Time Frame: up to Day 10 ]
  3. Area under the plasma concentration-time curve extrapolated to infinity AUC (INF) [ Time Frame: up to Day 10 ]

Secondary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: Approximately 50 days ]
  2. Number of significant changes in lab assessments of blood serum [ Time Frame: Approximately 50 days ]
  3. Number of significant changes in lab assessments of blood [ Time Frame: Approximately 50 days ]
  4. Number of significant changes in lab assessments of urine [ Time Frame: Approximately 50 days ]
  5. Blood pressure [ Time Frame: Approximately 50 days ]
  6. Body temperature [ Time Frame: Approximately 50 days ]
  7. Respiratory rate [ Time Frame: Approximately 50 days ]
  8. Number of Participants with abnormal physical examination findings [ Time Frame: Approximately 50 days ]
  9. Heart rate [ Time Frame: Approximately 50 days ]
  10. Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities [ Time Frame: Approximately 50 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Healthy participants, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
  • Women must not be of childbearing potential (WNOCBP)
  • Women and men must agree to follow instructions for methods of contraception

Exclusion Criteria:

  • Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study.
  • Any major surgery within 4 weeks of study drug administration
  • Any blood transfusion or donation of blood to a blood bank or in a clinical study within 4 weeks of study drug administration
  • Previous treatment with BMS-963272
  • Participants who smoke, as well as, those who have stopped smoking less than 6 months prior to day 1

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): NCT04124003


Locations
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United States, Utah
Local Institution Recruiting
Salt Lake City, Utah, United States, 84124
Contact: Site 0001    801-904-4545    searleshawn@prahs.com   
Sponsors and Collaborators
Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04124003     History of Changes
Other Study ID Numbers: MB006-018
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019

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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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Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors