Clinical trial NCT02101125: Drug Interaction Study With Rosuvastatin
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Immunosuppression For Disease
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-04-01
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of Rosuvastatin with and without coadministered BMS-986020
timeFrame: 31 timepoints up to Day 12
measure: 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
timeFrame: 31 timepoints up to Day 12
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of Rosuvastatin with and without coadministered BMS-986020
timeFrame: 31 timepoints up to Day 12
Secondary outcomes:
measure: Time of maximum observed plasma concentration (Tmax) of Rosuvastatin with and without coadministered BMS-986020
timeFrame: 31 timepoints up to Day 12
measure: Terminal plasma half-life (T-HALF) of Rosuvastatin with and without coadministered BMS-986020
timeFrame: 31 timepoints up to Day 12
measure: Apparent total body clearance (CLT/F) of Rosuvastatin with and without coadministered BMS-986020
timeFrame: 31 timepoints up to Day 12
measure: Incidence of Adverse Event (AEs), Serious Adverse Event (SAEs), deaths, and AEs leading to discontinuation
timeFrame: Upto Day 12
measure: Results of vital signs, ECGs, Physical Examination (PEs), and clinical lab result
timeFrame: Up to Day 12
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Healthcare Discoveries, Llc D/B/A Icon Development Solutions
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: