Effect of BMS-986165 on the Pharmacokinetics of Rosuvastatin

Autoimmune Diseases Clinical Trial

Official title:

Effect of BMS-986165 on the Pharmacokinetics of Rosuvastatin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03044873
• Other study ID #: IM011-015
• Status: Completed
• Phase: Phase 1
• First received: February 3, 2017
• Last updated: April 13, 2017
• Start date: February 2, 2017
• Est. completion date: March 27, 2017

Study information

• Verified date: April 2017
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 27, 2017
• Est. primary completion date: March 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Inflammatory Diseases

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	PPD Phase I Clinic	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax (Maximum observed plasma concentration) of Rosuvastatin.	Measured by plasma concentration.	Up to Day 13
Primary	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.	Up to Day 13
Primary	AUC(INF) (Area under the plasma concentration-time curve from time zero extrapolated to infinite time) of Rosuvastatin.	Measured by plasma concentration.	Up to Day 13
Secondary	Number of Subjects with Deaths.	Measured by investigator assessment.	Up till 30 days after discontinuation
Secondary	Number of Subjects with Serious Adverse Events.	Measured by investigator assessment.	Up till 30 days after discontinuation
Secondary	Number of Subjects with Adverse Events.	Measured by investigator assessment.	Up till 30 days after discontinuation
Secondary	Number of subjects with Adverse Events Leading to Discontinuation.	Measured by investigator assessment.	Up till 30 days after discontinuation

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form