Study Evaluating Potential Pharmacokinetic (PK) Interaction Between Lecozotan and Digoxin
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...
Brief Summary
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: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: September 2008
Intervention(s) in this Clinical Trial
- Drug: Lecozotan
Outcome Measures for this Clinical Trial
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
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Wyeth is now a wholly owned subsidiary of Pfizer Industry
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Wyeth is now a wholly owned subsidiary of Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00563732
