Official Title: “An Open-Label, Nonrandomized Study to Evaluate the Potential Pharmacokinetic Interaction Between Multiple Doses of Lecozotan SR and a Single Oral Dose of Digoxin When Administered Orally to Healthy Adult Subjects”

Primary: To evaluate the effects of multiple doses of lecozotan SR on the PK profile of a single dose of digoxin in healthy adult subjects.

Secondary: To assess the safety and tolerability of the coadministration of lecozotan SR and digoxin.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Intervention(s) in this Clinical Trial

• Drug: Lecozotan

Primary Measures

• Evaluation of the effects of multiple doses of lecozotan SR on the PK profile of a single dose of digoxin in healthy adult subjects

Inclusion Criteria:

• Women of non childbearing potential and men aged 18 to 55 years at screening.
• Body mass index (BMI) in the range of 18 to 30 kg/m2 and body weight 50 kg (BMI = weight (kg)/[height (m)]

Exclusion Criteria:

• Presence or history of any disorder that may prevent the successful completion of the study.
• Any clinically important deviation from normal limits in physical examination, vital signs or clinical laboratory test results.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Wyeth

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Wyeth  

Overall Contact: Trial Manager  clintrialparticipation@wyeth.com

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00563732

Study ID Number: 3098B1-1142

ClinicalTrials.gov Identifier: NCT00563732

Health Authority: France: Ministry of Health