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The Food-effect on Alectinib Pharmacokinetics

NCT05710133 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-06-27

No results posted yet for this study

Summary

The goal of this food-effect study on Alectinib pharmacokinetics is to learn about the food effect of alectinib. The main question aims to answer is:

• To determine the food-effect of a standardized Dutch breakfast on the pharmacokinetics of oral alectinib (Alecensa®), especially Peak Plasma Concentration (Cmax), Area under the plasma concentration versus time curve (AUC) and relative bioavailability, at steady state using a stable isotopically labelled microtracer approach.

Participants will take alectinib-d6 (microtracer) with and without food on different days.

Conditions

Interventions

OTHER

food

alectinib-d6 will be administered with breakfast on day 1 to determine the food-effect

OTHER

fast

alectinib-d6 will be administered after an overnight fast of minimal 10 hours on day 9 to determine the food-effect

Sponsors & Collaborators

  • The Netherlands Cancer Institute

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2024-10-04
Completion
2024-10-04

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05710133 on ClinicalTrials.gov