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

Completed · Phase 1

Conditions studied: Drug Pharmacokinetics in Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT03699774

Run by

Daiichi Sankyo

People needed

24

Starts

2015-05-12

Expected to finish

2015-07-06

Last updated by the study team

2019-02-12

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Worldwide Clinical Trials (WCT) Early Phase Services — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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