Effect of BMS-986165 on the Pharmacokinetics of Rosuvastatin

Phase 1

Completed

• Conditions: Inflammatory Diseases; Autoimmune Diseases
• Interventions: Drug: BMS-986165; Drug: Rosuvastatin

• Registration Number: NCT03044873
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-02
• Study First Submitted: 2017-02-03
• Study First Submitted QC: 2017-02-06
• Study First Posted: 2017-02-07
• Primary Completion: 2017-03-14
• Study Completion: 2017-03-27
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-13
• Last Update Posted: 2017-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Other protocol defined inclusion/exclusion criteria could apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BMS 986165 and Rosuvastatin	BMS-986165	-
BMS 986165 and Rosuvastatin	Rosuvastatin	-

Primary Outcome Measures

Name	Time	Method
Cmax (Maximum observed plasma concentration) of Rosuvastatin.	Up to Day 13	Measured by plasma concentration.
AUC(0-T) (Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration) of Rosuvastatin.	Up to Day 13	Measured by plasma concentration.
AUC(INF) (Area under the plasma concentration-time curve from time zero extrapolated to infinite time) of Rosuvastatin.	Up to Day 13	Measured by plasma concentration.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects with Deaths.	Up till 30 days after discontinuation	Measured by investigator assessment.
Number of Subjects with Serious Adverse Events.	Up till 30 days after discontinuation	Measured by investigator assessment.
Number of Subjects with Adverse Events.	Up till 30 days after discontinuation	Measured by investigator assessment.
Number of subjects with Adverse Events Leading to Discontinuation.	Up till 30 days after discontinuation	Measured by investigator assessment.

Trial Locations

Locations (1)

PPD Phase I Clinic; 🇺🇸 Austin, Texas, United States