Drug Interaction Study With Rosuvastatin

NCT02101125 | Completed Phase 1

• 1 other identifier: IM136-122
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Immunosuppression For Disease

Outcome Measures

Primary Outcomes (3)

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

  31 timepoints up to Day 12

• 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

  31 timepoints up to Day 12

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

  31 timepoints up to Day 12

Secondary Outcomes (5)

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

  31 timepoints up to Day 12

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

  31 timepoints up to Day 12

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

  31 timepoints up to Day 12

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

  Upto Day 12

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

  Up to Day 12

Study Arms (1)

BMS-986020 + Rosuvastatin (Treatment A, B and C)

EXPERIMENTAL

Cohort 1: Rosuvastatin Tablet Single dose and BMS- 986020 orally on specific days Cohort 2 (Administered 4 hrs, after the morning dose of BMS-986020): Rosuvastatin Tablet Single dose and BMS- 986020 orally on specific days

Drug: BMS-986020; Drug: Rosuvastatin

Interventions

BMS-986020 DRUG

Also known as: Lysophosphatidic acid (LPA1) Antagonist

BMS-986020 + Rosuvastatin (Treatment A, B and C)

Rosuvastatin DRUG

Also known as: Crestor

BMS-986020 + Rosuvastatin (Treatment A, B and C)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

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

San Antonio, Texas, 78209, United States

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Interventions

lysophosphatidic acid; Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2014
• First Posted: April 1, 2014
• Study Start: March 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 17, 2014

Record last verified: 2014-06

Locations

US (1)