Exploratory Study of Inhaled Afatinib Dimaleate PK Profile

Launched by PETROV, ANDREY · Mar 26, 2025

Keywords

ClinConnect Summary

Participants will receive either a single dose of inhaled afatinib dimaleate or a 40 mg oral dose of afatinib dimaleate in a randomized sequence, with a 7-day washout period between treatments.

The inhaled formulation of afatinib dimaleate is administered via a single-use, maintenance-free ultrasonic nebulizer (by SWITZERLAND TEAM) that generates aerosol particles of a defined size, ensuring predictable bioavailability and targeted alveolar deposition. Each inhalation session consists of a predefined number of physiological breaths, facilitating efficient drug uptake into the lungs at ther...

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