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

Wyeth is now a wholly owned subsidiary of Pfizer

Overview

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Alzheimer Disease

Interventions

LecozotanDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Evaluation of the effects of multiple doses of lecozotan SR on the PK profile of a single dose of digoxin in healthy adult subjects

Data from ClinicalTrials.gov

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