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Clinical Trials/ACTRN12620001141932
ACTRN12620001141932CompletedPhase 1

A Phase 1 Study to evaluate the Pharmacokinetics, Safety and Tolerability of AP02 (Nintedanib Solution for Inhalation) Delivered via the PARI eFlow® Nebulizer System (registered) in Normal Healthy Volunteers and Patients with Idiopathic Pulmonary Fibrosis or Progressive Fibrosing Interstitial Lung Disease

Avalyn Pharma Pty Ltd0 sites38 target enrollmentStarted: November 2, 2020Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
38
Study OverviewStudy DesignEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomised controlled trial
Primary Purpose
Treatment
Masking
Blinded (masking used)

Eligibility Criteria

Ages
18 Years to 80 Years (—)
Sex
All

Inclusion Criteria

  • •A subject must meet all of the following inclusion criteria to be eligible to enroll in the clinical trial:
  • •Inclusion Criteria for all Cohorts:
  • •1. Males or females 18 to 55 years of age.
  • •2. Female subjects must be:
  • •Of non-childbearing potential [surgically sterilized or post–menopausal (12 months with no menses without alternative medical cause)] OR
  • •Not pregnant, breast feeding or planning to become pregnant AND willing to comply with the medically acceptable contraceptive requirements of the study from Screening to at least 30 days after the last study drug administration.
  • •3. Must be able to communicate with site personnel and to understand and voluntarily sign the Informed Consent Form (ICF).
  • •4. Have not had any coronavirus disease 2019 vaccines within 7 days of the AP02 dose (Day 1) and, willing to not receive any coronavirus vaccine 7 days after receiving AP02.
  • •5. Have not had any Influenza virus vaccines within 7 days of the AP02 dose (Day 1) and, willing to not receive any Influenza virus vaccine 7 days after receiving AP02.
  • •Additional Inclusion Criteria for Cohort 6 only:
  • •6. Diagnosis of IPF based on American Thoracic Society (ATS)/ European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) 2018 Guidelines OR
  • •Diagnosis of PFILD by at least one of the following criteria within 24 months of screening visit:
  • •a. Clinically significant decline in Forced Vital Capacity (FVC) % predicted based on a relative decline of greater than or equal to 10%
  • •b. Marginal decline in FVC % predicted based on a relative decline of greater than or equal to 5 to less than 10% combined with worsening of respiratory symptoms
  • •c. Marginal decline in FVC % predicted based on a relative decline of greater than or equal to 5 to less than 10% combined with increasing extent of fibrotic changes on chest imaging
  • •d. Worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest imaging [Note: Changes attributable to comorbidities e.g. infection, heart failure must be excluded. Off label medications used in the clinical practice to treat PFILD include but are not limited to corticosteroid, azathioprine, mycophenolate mofetil (MMF), n-acetylcysteine (NAC), rituximab, cyclophosphamide, cyclosporine, tacrolimus].
  • •7. Males or females 18 to 80 years of age.

Exclusion Criteria

  • •The presence of any of the following exclusion criteria excludes a subject from study enrollment:
  • •Exclusion Criteria for all Cohorts:
  • •1. History of previous allergy or sensitivity to nintedanib.
  • •2. History of reactive airways disease (such as asthma or chronic obstructive pulmonary disease (COPD), cystic fibrosis, or bronchiectasis (Cohorts 1-5 only). Cohort 6 will exclude cystic fibrosis and bronchiectasis but will allow a history of COPD or asthma. Patients with fully resolved childhood asthma with no recurrences or medical needs as an adult are permitted.
  • •3. History of bleeding disorders or currently being treated with anticoagulants.
  • •4. Human Immunodeficiency Virus Positive (HIV+) Result.
  • •5. Active Hepatitis B or C.
  • •6. Cigarette/e-Cigarette smoking or use of other nicotine or tobacco containing products within 7 days prior to study drug administration.
  • •7. Positive for drugs of abuse or alcohol use at screening or admission to Phase 1 facility. A breathalyzer test will be used to screen for the presence of alcohol. A standard urine panel will be used to test for the following substances (with repeat testing for confirmation, as needed) (Cohorts 1-5 only):
  • •Methadone
  • •Tetrahydrocannabinol
  • •Benzodiazepines
  • •Amphetamines / Methamphetamines
  • •Barbiturates
  • •3,4-methylenedioxy-methamphetamine
  • •Phencyclidine
  • •8. Participation in a clinical study with administration of an investigational drug product within the previous 30 days or 5 half-lives (t1/2) of the previously administered investigational product.
  • •9. Donation of blood or significant blood loss within the 8 weeks prior to admission to Phase 1 facility.
  • •10. Donation of plasma within the week prior to admission to Phase 1 facility.
  • •11. Any other condition, which in the view of the investigator is likely to interfere with the study or put the subject at risk.
  • •12. Use of any medication, which in the opinion of the investigator that that might interact with study drug or may lead to abnormal chemistry of hematology tests.
  • •13. Aspartate aminotransferase or alanine aminotransferase (AST or ALT) > 1.5X upper limit of normal.
  • •14. Clinically significant abnormality in the opinion of the principal investigator in baseline hematology or chemistry tests.
  • •15. Use of anti-platelet drugs with the exception of low-dose aspirin for patients in Cohort 6.

Investigators

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A Phase 1 Study of AP02 (Nintedanib... | Clinical Trial