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

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: SAM-531 and gemfibrozil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00966966

3193A1-1109

B1961001

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

1

Experimental group

Description:

SAM-531_gemfibrozil

Treatment:

Drug: SAM-531 and gemfibrozil