Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT05710133
Eligibility Criteria:
Inclusion Criteria:
1. Currently treated with alectinib for NSCLC or other oncological indications;
2. On alectinib treatment at a stable dose of 600 mg twice daily (≥ 7 days) according to standard of care
3. Age ≥ 18 years;
4. Able and willing to give written informed consent;
5. world health organization (WHO) performance status of 0,1 or 2;
6. Able and willing to undergo blood sampling for pharmacokinetic analysis;
7. Able and willing to get one intravenous line for pharmacokinetic sampling
8. Able and willing to comply with study restrictions and to remain at the study center for the required duration.
9. Able and willing to undergo the defined food interventions
Exclusion Criteria:
1. Any treatment with investigational drugs (alectinib-d6) within 30 days or 5 half-lives prior to receiving the investigational treatment;
2. 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;
3. 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05710133
Study Brief:
Protocol Section:
NCT05710133