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Completed

NCT Number: NCT02101125

Drug Interaction Study With Rosuvastatin

The purpose of this study is to evaluate the effect of concomitant administration of BMS-986020 on the single dose Pharmacokinetics (PK) of Rosuvastatin in healthy subjects.

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Key information

Conditions

Immunosuppression For Disease

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Healthcare Discoveries, Llc D/B/A Icon Development Solutions

San Antonio, Texas, 78209, United States

Who can participate

Healthy volunteers accepted: Yes

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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion criteria

  • Healthy subjects who have no clinically significant deviation from normal in medical history, surgical history, PE, vital signs, ECG, and clinical laboratory determinations
  • Nonsmokers
  • Body Mass Index (BMI) of 18.0 to 32.0 kg/m2, inclusive. Men, ages 18 to 50 years, inclusive
  • Men and women, ages 18 to 50 years, inclusive
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of investigational product
  • Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) (11 days) plus 5 half-lives of the study drug (4 days) plus 90 days (duration of sperm turnover) for a total of 94 days posttreatment completion

Exclusion criteria

  • Any significant acute or chronic medical illness
  • Current or recent (within 3 months of study drug administration) gastrointestinal disease
  • Any major surgery within 4 weeks of study drug administration
  • Any gastrointestinal surgery (eg, partial gastrectomy, pyloroplasty) including cholecystectomy that could impact upon the absorption of study drug
  • Donation of > 400 mL of blood within 8 weeks or donation of plasma (except at screening visit) within 4 weeks of study drug administration
  • Blood transfusion within 4 weeks of study drug administration
  • Inability to tolerate oral medication
  • Inability to be venipunctured and/or tolerate venous access as determined by the investigator
  • Use of tobacco-containing or nicotine containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to check-in, or a positive nicotine test (ie, cotinine) at screening or check-in
  • Subjects who drink more than 3 cups of coffee or other caffeine containing products with an equivalent amount of caffeine per day, or 5 cups of tea per day
  • History of allergy to Lysophosphatidic acid (LPA1) antagonists or related compounds

Treatment and study plan

BMS-986020

Drug

Other names: Lysophosphatidic acid (LPA1) Antagonist

Rosuvastatin

Drug

Other names: Crestor

Primary outcomes

  1. Maximum observed plasma concentration (Cmax) of Rosuvastatin with and without coadministered BMS-986020

    Time frame: 31 timepoints up to Day 12

  2. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Rosuvastatin with and without coadministered BMS-986020

    Time frame: 31 timepoints up to Day 12

  3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of Rosuvastatin with and without coadministered BMS-986020

    Time frame: 31 timepoints up to Day 12

Secondary outcomes

  1. Time of maximum observed plasma concentration (Tmax) of Rosuvastatin with and without coadministered BMS-986020

    Time frame: 31 timepoints up to Day 12

  2. Terminal plasma half-life (T-HALF) of Rosuvastatin with and without coadministered BMS-986020

    Time frame: 31 timepoints up to Day 12

  3. Apparent total body clearance (CLT/F) of Rosuvastatin with and without coadministered BMS-986020

    Time frame: 31 timepoints up to Day 12

  4. Incidence of Adverse Event (AEs), Serious Adverse Event (SAEs), deaths, and AEs leading to discontinuation

    Time frame: Upto Day 12

  5. Results of vital signs, ECGs, Physical Examination (PEs), and clinical lab result

    Time frame: Up to Day 12

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1 Open-label, Single-sequence Study to Evaluate the Effect of Concomitant Administration of BMS-986020 on the Single-dose Pharmacokinetics of Rosuvastatin in Healthy Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 1, 2014
Registry last updated
Jun 17, 2014

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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