The Food-effect on Alectinib Pharmacokinetics

NCT05710133 | Completed

• 2 other identifiers: N20FEA2021-006957-69
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

NSCLC

Outcome Measures

Primary Outcomes (2)

• food-effect on alectinib

  To determine the food-effect of a standardised Dutch breakfast on the pharmacokinetics (Cmax) of oral alectinib (Alecensa®), at steady state using a stable isotopically labelled microtracer approach.

  10 days

• food-effect on alectinib

  To determine the food-effect of a standardised Dutch breakfast on the pharmacokinetics (AUC and relative bioavailability (F)) of oral alectinib (Alecensa®), at steady state using a stable isotopically labelled microtracer approach. looking at Cmax

  10 days

Study Arms (1)

alectinib-d6

OTHER

Patients will receive one single dose of alectinib-d6 (100 µg) orally on day 1 and 9.

Other: food; Other: fast

Interventions

food OTHER

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

Also known as: food state

alectinib-d6

fast OTHER

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

Also known as: fast state

alectinib-d6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently treated with alectinib for NSCLC or other oncological indications;
• On alectinib treatment at a stable dose of 600 mg twice daily (≥ 7 days) according to standard of care
• Age ≥ 18 years;
• Able and willing to give written informed consent;
• world health organization (WHO) performance status of 0,1 or 2;
• Able and willing to undergo blood sampling for pharmacokinetic analysis;
• Able and willing to get one intravenous line for pharmacokinetic sampling
• Able and willing to comply with study restrictions and to remain at the study center for the required duration.
• Able and willing to undergo the defined food interventions

You may not qualify if:

• Any treatment with investigational drugs (alectinib-d6) within 30 days or 5 half-lives prior to receiving the investigational treatment;
• Any treatment with inhibitors of CYP3A4 (e.g. boceprevir, clarithromycin, erythromycin, indinavir, itraconazole, ketoconazole, ritonavir and voriconazole), inhibitors of Pgp (e.g. cyclosporine, kinidine, and verapamil), inhibitors of breast cancer resistance protein (BCRP) (e.g. lapatinib), inductors of CYP3A4, Pgp or BCRP;
• Patients suffering from any known disease or dysfunction that might influence the dissolution and/or absorption of alectinib (e.g. inflammatory bowel disease, gastric bypass).

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead

Study Sites (1)

Netherlands Cancer Institute

Amsterdam, North Holland, 1066 CX, Netherlands

Location

MeSH Terms

Interventions

Food

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: February 2, 2023
• Study Start: February 1, 2024
• Primary Completion: October 4, 2024
• Study Completion: October 4, 2024
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

NL (1)