Effect of Repeated Doses of DS-8500a on Pharmacokinetics of Rosuvastatin in Healthy Volunteers

• Status: Completed
• Trial end date: 2015-07-06
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to assess the effect of repeated doses of DS-8500a on the single dose pharmacokinetics (PK) of rosuvastatin.

The total length of time (from screening to follow-up) for each participant is approximately 7 weeks.

It is expected that repeated oral doses of DS-8500a will not have a significant effect on the pharmacokinetics of a single dose of rosuvastatin.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Daiichi Sankyo, Inc.
• Treatments: Firuglipel; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• Is healthy and of non-child-bearing potential

• Has a body mass index of 18-30 kg/m^2

• Has negative results for drugs of abuse, cotinine (smoking) and alcohol at screening

• Has signed informed consent and agreed to comply with all study requirements

Exclusion Criteria:

• Has history or current evidence of clinically significant cardiac, hepatic, renal, pulmonary, endocrine/metabolic, neurologic, infectious, gastrointestinal , hematologic, or oncologic disease as determined by screening history, physical examination, laboratory test results, or 12-lead ECG

• Has any other condition detailed in the protocol, or that in the opinion of the Investigator, precludes participation in the study