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

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00745576
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arm: 1
• Duration (Months): 2
• Patients Per Site Per Month: 7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease	Drug: SAM-531	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Nonrandomized Study to Evaluate the Potential Pharmacokinetic Interaction Between Multiple Doses of Verapamil Immediate Release (IR) and a Single Dose of SAM-531 When Co-administered Orally to Healthy Young Adult Subjects
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: SAM-531

Outcome Measures

Primary Outcome Measures

1. blood samples [7 weeks]

Secondary Outcome Measures

1. Safety based on supine vital signs evaluations, 12-lead ECGs and routine lab tests [7 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Gieres		France	38610

Sponsors and Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

• Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00745576
• Other Study ID Numbers: 3193A1-1112
• First Posted: Sep 3, 2008
• Last Update Posted: Feb 8, 2010
• Last Verified: Feb 1, 2010

• Additional relevant MeSH terms: Alzheimer Disease

Study Results

No Results Posted as of Feb 8, 2010