Back to resultsStudy Evaluating Potential Pharmacokinetic (PK) Interaction Between Lecozotan and Digoxin
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Lecozotan
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease
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.
Sites / Locations
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00563732
First Posted
November 21, 2007
Last Updated
September 8, 2008
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00563732
Brief Title
Study Evaluating Potential Pharmacokinetic (PK) Interaction Between Lecozotan and Digoxin
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 Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lecozotan
Primary Outcome Measure Information:
Title
Evaluation of the effects of multiple doses of lecozotan SR on the PK profile of a single dose of digoxin in healthy adult subjects
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating Potential Pharmacokinetic (PK) Interaction Between Lecozotan and Digoxin
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