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

Wyeth

Status and phase: Completed; Phase 1

Conditions: Alzheimer Disease

Treatments: Drug: Lecozotan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00563732

3098B1-1142

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)