Study Evaluating Potential Pharmacokinetic (PK) Interaction Between Lecozotan and Digoxin

This study has been completed.

First Received: November 21, 2007 Last Updated: September 8, 2008 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00563732

Purpose

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.

Condition	Intervention	Phase
Alzheimer Disease	Drug: Lecozotan	Phase I

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

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Digoxin Lecozotan

Further study details as provided by Wyeth:

Primary Outcome 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

Study Start Date:	December 2007
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Eligibility

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00563732

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Study ID Numbers:	3098B1-1142
Study First Received:	November 21, 2007
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00563732 History of Changes
Health Authority:	France: Ministry of Health; United States: Food and Drug Administration

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Digoxin
Central Nervous System Diseases
Healthy

Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on September 10, 2009