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OpenTrials
Completed

NCT Number: NCT04124003

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

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

Completed

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Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences - Salt Lake

Salt Lake City, Utah, 84124, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin

Drug

Specified dose on specified days

BMS-963272

Drug

Specified dose on specified days

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 11, 2019
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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