Study Evaluating The Potential Interaction Between Verapamil Immediate Release And SAM-531 When Co-Administered

Wyeth

Status and phase: Completed; Phase 1

Conditions: Alzheimer Disease

Treatments: Drug: SAM-531

Study type: Interventional

Funder types: Industry

Identifiers

NCT00745576

3193A1-1112

Details and patient eligibility

About

The purpose of this study is to evaluate the effects of multiple doses of verapamil 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 verapamil.

Enrollment: 14 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria :

1. Body mass index in the range of 18 to 30 kg/m2 and body weight greater than 50 kg.
2. 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 :

1. Presence or history of any disorder that may prevent the successful completion of the study.
2. 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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14 participants in 1 patient group

1

Experimental group

Treatment:

Drug: SAM-531