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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00563732
First received: November 21, 2007
Last updated: September 8, 2008
Last verified: September 2008
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

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

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 14, 2014