NCT03699774

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

An Open-label, Fixed Sequence, Two-period Study to Evaluate the Effects of Repeated Doses of DS-8500a on the Pharmacokinetics of Rosuvastatin in Healthy Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Drug Pharmacokinetics in Healthy Volunteers

Interventions

Type	Name	Description
DRUG	DS-8500a	DS-8500a is provided as three 25-mg tablets for oral administration
DRUG	Rosuvastatin	Rosuvastatin is provided as a 10-mg tablet for oral administration

Timeline

• Start date: 2015-05-12
• Primary completion: 2015-07-06
• Completion: 2015-07-06
• First posted: 2018-10-09
• Last updated: 2019-02-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study