Study Evaluating Potential Interaction Between SAM-531 And Gemfibrozil When Co-Administered

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

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2009-12-31

Brief Summary

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The purpose of this study is to evaluate the effects of multiple doses of Gemfibrozil on the plasma concentration of a single dose of SAM-531 in healthy young adult subjects and to assess the safety and tolerability of co-administration of SAM-531 and Gemfibrozil.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

SAM-531\_gemfibrozil

Group Type EXPERIMENTAL

SAM-531 and gemfibrozil

Intervention Type DRUG

2 single doses of 5 mg SAM-531 (capsules) a daily dose of 1200 mg Gemfibrozil (one tablet of 600mg at approximately 8 a.m. and one tablet of 600 mg at approximately 6 p.m.) for 14 days

Interventions

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SAM-531 and gemfibrozil

2 single doses of 5 mg SAM-531 (capsules) a daily dose of 1200 mg Gemfibrozil (one tablet of 600mg at approximately 8 a.m. and one tablet of 600 mg at approximately 6 p.m.) for 14 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body mass index in the range of 18 to 30 kg/m2 and body weight greater than 50 kg.
* Healthy as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12-lead ECG readings.

Exclusion Criteria

* Presence or history of any disorder that may prevent the successful completion of the study.
* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal (GI), endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes