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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06897735




Registration number
NCT06897735
Ethics application status
Date submitted
2/03/2025
Date registered
27/03/2025

Titles & IDs
Public title
Exploratory Study of Inhaled Afatinib Dimaleate PK Profile
Scientific title
A Phase I Pilot Study to Evaluate the Bioequivalence, Pharmacokinetics, and Safety of Inhaled Afatinib Dimaleate Compared to the Reference Oral Afatinib Dimaleate in Healthy Smoking Volunteers (EDDIS-a1)
Secondary ID [1] 0 0
233-1-10AfD
Universal Trial Number (UTN)
Trial acronym
EDDIS-a1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 0 0
Oral Cancer 0 0
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Afatinib Dimaleat
Treatment: Other - inhalation of afatinib dimaleate

Experimental: Afatinib Dimaleate inhalation form (liquid for inhalation) - Single-dose administration of inhaled afatinib dimaleate via an ultrasonic inhaler (healthy volunteer smokers only)

Active comparator: Reference Afatinib Dimaleate - Single oral administration of reference afatinib dimaleate 40 mg capsule (healthy volunteer smokers only)


Treatment: Drugs: Afatinib Dimaleat
printed capsule containing 40 mg afatinib dimaleate

Treatment: Other: inhalation of afatinib dimaleate
inhalation stable form of afatinib dimaleate at an equivalent therapeutic dose in a single-use maintenance-free ultrasonic inhaler with controlled frequency and number of inhalations
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cmax (maximum observed plasma concentration)
Timepoint [1] 0 0
up to 48 hours post-dose
Primary outcome [2] 0 0
afatinib dimaleate urinary concentrations
Timepoint [2] 0 0
up to 96 hours
Secondary outcome [1] 0 0
AUC (Area Under the Plasma Concentration-Time Curve)
Timepoint [1] 0 0
up to 48 hours post-dose/inhalations

Eligibility
Key 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
Minimum age
21 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
* ?articipation in other studies

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
19/04/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
20/07/2025
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
Petrov, Andrey
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ruslan Lytvyn
Address 0 0
Country 0 0
Phone 0 0
+64272550534
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06897735