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

Alzheimer Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00745576
• Other study ID #: 3193A1-1112
• Status: Completed
• Phase: Phase 1
• First received: September 2, 2008
• Last updated: February 5, 2010
• Start date: October 2008
• Est. completion date: December 2008

Study information

• Verified date: February 2010
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Institutional Ethical CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• SAM-531

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood samples		7 weeks	No
Secondary	Safety based on supine vital signs evaluations, 12-lead ECGs and routine lab tests		7 weeks	Yes