Back to resultsEffect of BMS-986165 on the Pharmacokinetics of Rosuvastatin
Primary Purpose
Autoimmune Diseases, Inflammatory Diseases
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-986165
Rosuvastatin
Sponsored by
About this trial
This is an interventional basic science trial for Autoimmune Diseases
Eligibility Criteria
Inclusion Criteria:
- Signed Informed Consent
- 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
- Subjects with body mass index of 18 to 32 kg/m2, inclusive.
- Women participants must have documented proof that they are not of childbearing potential.
- 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:
- 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
- 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
- History of chronic headaches, syncope, orthostatic instability, or recurrent dizziness, biliary disorders, drug-induced acne or rash, fibromyalgia, neutropenia or thrombocytopenia
- 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
Sites / Locations
- PPD Phase I Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BMS 986165 and Rosuvastatin
Arm Description
Outcomes
Primary Outcome Measures
Cmax (Maximum observed plasma concentration) of Rosuvastatin.
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.
Measured by plasma concentration.
AUC(INF) (Area under the plasma concentration-time curve from time zero extrapolated to infinite time) of Rosuvastatin.
Measured by plasma concentration.
Secondary Outcome Measures
Number of Subjects with Deaths.
Measured by investigator assessment.
Number of Subjects with Serious Adverse Events.
Measured by investigator assessment.
Number of Subjects with Adverse Events.
Measured by investigator assessment.
Number of subjects with Adverse Events Leading to Discontinuation.
Measured by investigator assessment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03044873
Brief Title
Effect of BMS-986165 on the Pharmacokinetics of Rosuvastatin
Official Title
Effect of BMS-986165 on the Pharmacokinetics of Rosuvastatin
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 2, 2017 (Actual)
Primary Completion Date
March 14, 2017 (Actual)
Study Completion Date
March 27, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Diseases, Inflammatory Diseases
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BMS 986165 and Rosuvastatin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BMS-986165
Intervention Description
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
Intervention Name(s)
Rosuvastatin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cmax (Maximum observed plasma concentration) of Rosuvastatin.
Description
Measured by plasma concentration.
Time Frame
Up to Day 13
Title
AUC(0-T) (Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration) of Rosuvastatin.
Description
Measured by plasma concentration.
Time Frame
Up to Day 13
Title
AUC(INF) (Area under the plasma concentration-time curve from time zero extrapolated to infinite time) of Rosuvastatin.
Description
Measured by plasma concentration.
Time Frame
Up to Day 13
Secondary Outcome Measure Information:
Title
Number of Subjects with Deaths.
Description
Measured by investigator assessment.
Time Frame
Up till 30 days after discontinuation
Title
Number of Subjects with Serious Adverse Events.
Description
Measured by investigator assessment.
Time Frame
Up till 30 days after discontinuation
Title
Number of Subjects with Adverse Events.
Description
Measured by investigator assessment.
Time Frame
Up till 30 days after discontinuation
Title
Number of subjects with Adverse Events Leading to Discontinuation.
Description
Measured by investigator assessment.
Time Frame
Up till 30 days after discontinuation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Signed Informed Consent
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
Subjects with body mass index of 18 to 32 kg/m2, inclusive.
Women participants must have documented proof that they are not of childbearing potential.
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:
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
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
History of chronic headaches, syncope, orthostatic instability, or recurrent dizziness, biliary disorders, drug-induced acne or rash, fibromyalgia, neutropenia or thrombocytopenia
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
PPD Phase I Clinic
City
Austin
State/Province
Texas
ZIP/Postal Code
78744
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.fda.gov/Safety/Recalls/
Description
FDA Safety Alerts and Recalls
Learn more about this trial
Effect of BMS-986165 on the Pharmacokinetics of Rosuvastatin
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