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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00563732

Enrollment

Unknown

Registered

2007-11-26

Start date

2007-12-31

Completion date

2008-09-30

Last updated

2008-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

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.

Interventions

DRUGLecozotan

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026