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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-12

Study Completion Date

2015-07-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Drug Pharmacokinetics in Healthy Volunteers

Study Design

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Intervention Model

SEQUENTIAL

Fixed sequence

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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All Participants

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.

Group Type EXPERIMENTAL

DS-8500a

Intervention Type DRUG

DS-8500a is provided as three 25-mg tablets for oral administration

Rosuvastatin

Intervention Type DRUG

Rosuvastatin is provided as a 10-mg tablet for oral administration

Interventions

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DS-8500a

DS-8500a is provided as three 25-mg tablets for oral administration

Intervention Type DRUG

Rosuvastatin

Rosuvastatin is provided as a 10-mg tablet for oral administration

Intervention Type DRUG

Other Intervention Names

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Experimental product Crestor

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes