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

Daiichi Sankyo

Status and phase: Completed; Phase 1

Conditions: Drug Pharmacokinetics in Healthy Volunteers

Treatments: Drug: Rosuvastatin; Drug: DS-8500a

Study type: Interventional

Funder types: Industry

Identifiers

NCT03699774

DS8500-A-U105

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

24 participants in 1 patient group

All Participants

Experimental group

Description:

In treatment Period 1 (Day 1 through Day 4), on Day 1, participants receive a single dose of rosuvastatin 10 mg orally with food, and in Period 2 (Day 1 through Day 16), starting on Day 1, participants receive DS-8500a 75 mg orally qd with food for 16 days with concomitant administration of a single dose of rosuvastatin 10 mg qd on Day 14. In both the periods, rosuvastatin and DS-8500a are administered after an overnight fast of 8 hours and within 10 minutes after consuming a standardized breakfast of 500 calories.

Treatment:

Drug: Rosuvastatin

Drug: DS-8500a