Effect of BMS-986165 on the Pharmacokinetics of Rosuvastatin

NCT ID: NCT03044873

Last Updated: 2017-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-02
• Study Completion Date: 2017-03-27

Brief Summary

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

Conditions

Autoimmune Diseases; Inflammatory Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

BMS 986165 and Rosuvastatin

Group Type: EXPERIMENTAL

BMS-986165

Intervention Type: 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

Intervention Type: 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.

Interventions

BMS-986165

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.

Intervention Type: DRUG

Rosuvastatin

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Signed Informed Consent

2. 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

3. Subjects with body mass index of 18 to 32 kg/m2, inclusive.

4. Women participants must have documented proof that they are not of childbearing potential.

5. 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

1. 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

2. 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

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

4. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

PPD Phase I Clinic

Austin, Texas, United States

Countries

United States

Related Links

http://www.fda.gov/Safety/Recalls/

FDA Safety Alerts and Recalls

http://www.bms.com/clinical_trials/pages/investigator_inquiry_form.aspx

Investigator Inquiry Form

Other Identifiers

IM011-015

Identifier Type: -

Identifier Source: org_study_id