Lung CancerPhase 1EDDIS-a1NCT06897735
Exploratory Study of Inhaled Afatinib Dimaleate PK Profile
A Phase 1 study testing Afatinib Dimaleat and inhalation of afatinib dimaleate in people with Lung Cancer and Oral Cancer, run by Petrov, Andrey at 1 site in New Zealand.
Trial 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 afatinib dimaleate compared with the reference oral afatinib dimaleate in healthy volunteer smokers. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Oral Cancer, Melanoma
- What is being tested?
- Afatinib Dimaleat and inhalation of afatinib dimaleate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteNew Zealand
- Study dates
- 9 Nov 2025to 25 May 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
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
Read the 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 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 therapeutically relevant doses.
Key assessments include blood sampling for pharmacokinetic (PK), LC-MS/MS, analysis, bronchoalveolar lavage (BAL) to evaluate pulmonary drug deposition, and spirometry to assess pulmonary safety.tests, CT.
The investigators aim to obtain data on the role of pulmonary P-glycoprotein (P-gp) transporters in actively expelling afatinib dimaleate back into the alveolar space, as well as its metabolism by cytochrome P450 enzymes (CYP3A4) during inhalation.
Additionally, statistically significant data on both drug lung deposition (DLD) and drug-induced lung injury (DILI) will be analyzed.
Pharmacokinetic parameters, including maximum plasma concentration (Cmax) and area under the concentration-time curve (AUC0-∞), will be evaluated through plasma sampling. BAL will be performed in a subset of participants to assess direct pulmonary drug deposition. Safety and tolerability will be monitored through adverse event reporting, laboratory testing, and spirometry.
- Conditions
- Lung Cancer, Oral Cancer, Melanoma
- Being tested
- Afatinib Dimaleat, inhalation of afatinib dimaleate
- Keywords
- Afatinib Dimaleate, BIBW2992 Dimaleate, GIOTRIF, GILOTRIF
- Medical subject headings
- Lung Neoplasms, Mouth Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Afatinib DimaleatDrug
Also called BIBW2992 Dimaleate, Gilotrif, Afatinib Dimaleate
printed capsule containing 40 mg afatinib dimaleate
inhalation of afatinib dimaleateBiological
Also called Afatinib Dimaleate, BIBW2992 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
| Study group | Role | What they receive |
|---|---|---|
| Afatinib Dimaleate inhalation form (liquid for inhalation) | Experimental | Single-dose administration of inhaled afatinib dimaleate via an ultrasonic inhaler (healthy volunteer smokers only) Receives: Drug: Afatinib Dimaleat; Biological: inhalation of afatinib dimaleate |
| Reference Afatinib Dimaleate | Active comparator | Single oral administration of reference afatinib dimaleate 40 mg capsule (healthy volunteer smokers only) Receives: Drug: Afatinib Dimaleat; Biological: inhalation of afatinib dimaleate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (maximum observed plasma concentration)
quantitative measurement of afatinib dimaleate in plasma
Measured: up to 48 hours post-dose
afatinib dimaleate urinary concentrations
quantitative measurement of afatinib dimaleate in urine of inhaled and oral afatinib dimaleate
Measured: up to 96 hours
Secondary outcomes (1)
AUC (Area Under the Plasma Concentration-Time Curve)
the total afatinib dimalete exposure integrated over time
Measured: up to 48 hours post-dose/inhalations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start9 Nov 2025
- Primary completion25 May 2026
- Study completion25 May 2026
Why it stopped: adjustment of the study design taking into account the receipt of primary data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomly assigned to receive inhaled or oral Afatinib Dimaleate treatment first, followed by a washout period, after which they will receive the alternative treatment Participants will receive either a single dose of inhaled afatinib dimaleate or 40 mg of oral afatinib dimaleate in a randomized sequence with a 7-day washout period between treatments. Inhaled afatinib dimaleate (liquid) is delivered using a maintenance-free, single-use ultrasonic nebulizer that generates aerosol particles of a defined size with the most efficient gas-dynamic characteristics for alveolar deposition. Each inhalation session consists of a defined number of breaths, which ensures the most efficient uptake of afatinib dimaleate aerosol in the lungs.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Petrov, Andrey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897735
- Sponsor's protocol ID
- 233-1-10AfD
- Acronym
- EDDIS-a1
- Status last verified
- May 2026
- First submitted
- 2 Mar 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT06897735
- Acronym / sponsor ID
- EDDIS-a1 / 233-1-10AfD
- Conditions
- Lung Cancer, Oral Cancer, Melanoma
- Keywords
- Afatinib Dimaleate, BIBW2992 Dimaleate, GIOTRIF, GILOTRIF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: adjustment of the study design taking into account the receipt of primary data
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Petrov, AndreyUniversity, hospital or other
- Study start
- 9 Nov 2025 (actual)
- Primary completion
- 25 May 2026 (actual)
- Study completion
- 25 May 2026 (actual)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 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 therapeutically relevant doses.
Key assessments include blood sampling for pharmacokinetic (PK), LC-MS/MS, analysis, bronchoalveolar lavage (BAL) to evaluate pulmonary drug deposition, and spirometry to assess pulmonary safety.tests, CT.
The investigators aim to obtain data on the role of pulmonary P-glycoprotein (P-gp) transporters in actively expelling afatinib dimaleate back into the alveolar space, as well as its metabolism by cytochrome P450 enzymes (CYP3A4) during inhalation.
Additionally, statistically significant data on both drug lung deposition (DLD) and drug-induced lung injury (DILI) will be analyzed.
Pharmacokinetic parameters, including maximum plasma concentration (Cmax) and area under the concentration-time curve (AUC0-∞), will be evaluated through plasma sampling. BAL will be performed in a subset of participants to assess direct pulmonary drug deposition. Safety and tolerability will be monitored through adverse event reporting, laboratory testing, and spirometry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to receive inhaled or oral Afatinib Dimaleate treatment first, followed by a washout period, after which they will receive the alternative treatment Participants will receive either a single dose of inhaled afatinib dimaleate or 40 mg of oral afatinib dimaleate in a randomized sequence with a 7-day washout period between treatments. Inhaled afatinib dimaleate (liquid) is delivered using a maintenance-free, single-use ultrasonic nebulizer that generates aerosol particles of a defined size with the most efficient gas-dynamic characteristics for alveolar deposition. Each inhalation session consists of a defined number of breaths, which ensures the most efficient uptake of afatinib dimaleate aerosol in the lungs.
| Arm | Type | Receives |
|---|---|---|
| Afatinib Dimaleate inhalation form (liquid for inhalation) | Experimental | Drug: Afatinib Dimaleat, Biological: inhalation of afatinib dimaleateSingle-dose administration of inhaled afatinib dimaleate via an ultrasonic inhaler (healthy volunteer smokers only) |
| Reference Afatinib Dimaleate | Active comparator | Drug: Afatinib Dimaleat, Biological: inhalation of afatinib dimaleateSingle oral administration of reference afatinib dimaleate 40 mg capsule (healthy volunteer smokers only) |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Afatinib DimaleatAlso: BIBW2992 Dimaleate, Gilotrif, Afatinib Dimaleateprinted capsule containing 40 mg afatinib dimaleate | Drug | Afatinib Dimaleate inhalation form (liquid for inhalation), Reference Afatinib Dimaleate |
| inhalation of afatinib dimaleateAlso: Afatinib Dimaleate, BIBW2992 Dimaleateinhalation 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 | Biological | Afatinib Dimaleate inhalation form (liquid for inhalation), Reference Afatinib Dimaleate |
Primary outcome
Cmax (maximum observed plasma concentration)
Time frame: up to 48 hours post-dose
quantitative measurement of afatinib dimaleate in plasma
afatinib dimaleate urinary concentrations
Time frame: up to 96 hours
quantitative measurement of afatinib dimaleate in urine of inhaled and oral afatinib dimaleate
1 secondary outcome
AUC (Area Under the Plasma Concentration-Time Curve)
Time frame: up to 48 hours post-dose/inhalations
Results and safety
The study was stopped early (reason given: adjustment of the study design taking into account the receipt of primary data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Afatinib Dimaleat and inhalation of afatinib dimaleate in people with Lung Cancer and Oral Cancer, run by Petrov, Andrey at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: adjustment of the study design taking into account the receipt of primary data). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (maximum observed plasma concentration) (time frame: up to 48 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.