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Completed

NCT Number: NCT03044873

Effect of BMS-986165 on the Pharmacokinetics of Rosuvastatin

The study is to assess the effect of coadministration of multiple doses of BMS-986165 on the systemic exposure of rosuvastatin in healthy participants.

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Key information

Conditions

Autoimmune Diseases Immune System Diseases Inflammatory Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD Phase I Clinic

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

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

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
  • 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
  • History of chronic headaches, syncope, orthostatic instability, or recurrent dizziness, biliary disorders, drug-induced acne or rash, fibromyalgia, neutropenia or thrombocytopenia
  • 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

Treatment and study plan

BMS-986165

Drug

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.

Rosuvastatin

Drug

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 7, 2017
Registry last updated
Apr 17, 2017

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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