Exploratory Study of Inhaled Afatinib Dimaleate PK Profile

Launched by PETROV, ANDREY · Mar 26, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to deliver a medication called afatinib dimaleate, which is used to treat lung cancer, oral cancer, and melanoma. The researchers want to see how well this medication works when inhaled compared to when it is taken as a pill. They will be looking at how much of the drug gets into the bloodstream and how it settles in the lungs. The trial will involve healthy adult volunteers who smoke, and participants will try both the inhaled version and the oral version of the medication at different times.

To be eligible for this study, participants must be between 21 and 55 years old, have a body mass index (BMI) within a certain range, and be smokers or users of e-cigarettes. They should not have any serious lung diseases or a history of specific cancer treatments. Participants will be closely monitored for any side effects or reactions during the trial. This study is not yet recruiting participants, but it aims to gather important information that could help improve treatment options for cancer patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy male and female volunteers aged 21 to 55 years
• • Body mass index (BMI) from 18.5 to 30.0 kg/m²
• • Smokers or people who use e-cigarettes or vapes
• • No history of serious lung disease or respiratory disorders
• • No history of EGFR-targeted therapy or chemotherapy
• • Ability to give informed consent and comply with study procedures
• Exclusion Criteria:
• • Pregnancy or lactation. (for female participants - 2 negative tests 10 days and 3 days before the start of the study)
• • Significant cardiovascular, hepatic, renal or neurological disorders. (ECG 30 days or earlier before the start of the study)
• • Recent use of any study drug (within 30 days) or prescription drugs that may affect the metabolism of afatinib
• • Known hypersensitivity to afatinib, its salts or derivatives of afatinib or related compounds
• • Рarticipation in other studies