Study Evaluating Potential Pharmacokinetic (PK) Interaction Between Lecozotan and Digoxin
Information source: Wyeth
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alzheimer Disease
Intervention: Lecozotan (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Overall contact:
Trial Manager, Email: clintrialparticipation@wyeth.com
Summary
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.
Clinical Details
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
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Primary outcome: Evaluation of the effects of multiple doses of lecozotan SR on the PK profile of a single dose of digoxin in healthy adult subjects
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Trial Manager, Email: clintrialparticipation@wyeth.com Additional Information
Starting date: December 2007
Ending date: March 2008
Last updated: November 23, 2007
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