Status:
NOT_YET_RECRUITING
Exploratory Study of Inhaled Afatinib Dimaleate PK Profile
Lead Sponsor:
Petrov, Andrey
Conditions:
Lung Cancer
Oral Cancer
Eligibility:
All Genders
21-55 years
Phase:
PHASE1
Brief Summary
This is a pilot Phase I open-label randomized single-dose two-period crossover study (in the EDDIS project) evaluating the bioequivalence, pharmacokinetics (PK), safety, and tolerability of inhaled af...
Detailed Description
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 7 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06897735
Start Date
November 9 2025
End Date
May 7 2026
Last Update
November 18 2025
Active Locations (1)
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1
Central Contact
Auckland, New Zealand