Clinical trial · Interventional
Exploratory Study of Inhaled Afatinib Dimaleate PK Profile
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): adjustment of the study design taking into account the receipt of primary data
Summary
Brief summary (as posted)
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 afatinib dimaleate compared with the reference oral afatinib dimaleate in healthy volunteer smokers. The study will enroll healthy adult volunteers smoker to assess the systemic exposure and lung deposition of inhaled afatinib dimaleate. Participants will receive both the test inhaled formulation and the reference oral formulation in separate periods with delayed phase between treatments. Key endpoints include maximum plasma concentration (Cmax), area under the concentration-time curve (AUC), and lung deposition assessed via bronchoalveolar lavage (BAL), frequency of occurrence of side effects and cases of toxicity during the studies
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Afatinib Dimaleat | Drug | — | UNRESOLVED |
| inhalation of afatinib dimaleate | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Afatinib Dimaleate inhalation form (liquid for inhalation)
- description
- Single-dose administration of inhaled afatinib dimaleate via an ultrasonic inhaler (healthy volunteer smokers only)
- interventionNames
- Drug: Afatinib Dimaleat
- Biological: inhalation of afatinib dimaleate
- type
- ACTIVE_COMPARATOR
- label
- Reference Afatinib Dimaleate
- description
- Single oral administration of reference afatinib dimaleate 40 mg capsule (healthy volunteer smokers only)
- interventionNames
- Drug: Afatinib Dimaleat
- Biological: inhalation of afatinib dimaleate
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available