Exploratory Study of Inhaled Afatinib Dimaleate PK Profile
Launched by PETROV, ANDREY · Mar 26, 2025
Trial Information
Current as of April 23, 2025
Not yet recruiting
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
About Petrov, Andrey
Petrov, Andrey is a dedicated clinical trial sponsor focused on advancing medical research and innovation. With a commitment to ethical standards and patient safety, the organization specializes in designing and managing clinical trials across various therapeutic areas. Leveraging a robust network of healthcare professionals and research institutions, Petrov, Andrey aims to facilitate the development of new therapies that address unmet medical needs. The sponsor is recognized for its collaborative approach and rigorous adherence to regulatory guidelines, ensuring that clinical studies are conducted with the utmost integrity and scientific rigor.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Auckland, , New Zealand
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported