Overview
A Phase 2 Study to Evaluate the Safety and Tolerability of PBI-4050 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Status:
Completed
Completed
Trial end date:
2017-01-01
2017-01-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This is a Phase 2, open-label, single-arm study of the safety and tolerability of PBI-4050 800 mg daily oral administration in 40 adult patients with IPF.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Liminal BioSciences Ltd.
ProMetic BioSciences Inc.
Criteria
Inclusion Criteria:1. Patient is an adult aged 40 years or older
2. Patient has signed written informed consent.
3. Patient has been diagnosed of IPF according to the most recent guideline on IPF
diagnosis and management released by American Thoracic Society (ATS), European
Respiratory Society (ERS), Japanese Respiratory Society (JRS), and Latin American
Thoracic Association (ALAT).
4. Female patients of childbearing potential must have a negative urine pregnancy test
and agree to use adequate birth control from screening throughout the study and for 30
days after the last study drug administration.
5. If a male patient has not been vasectomized at least 6 months before screening and
partners with a woman of childbearing potential, he must be willing to use an
acceptable contraceptive method throughout the study and for 30 days after the last
study drug administration.
Exclusion Criteria:
1. Patient has a known diagnosis of a respiratory disorder other than IPF.
2. Substantial emphysema on high resolution computer tomography (HRCT) with degree of
emphysema greater than fibrosis.
3. Patient is an active smoker.
4. Patient has evidence of active infection.
5. Patients currently has or has a history of cancer, except basal cell carcinoma or
squamous cell carcinoma of the skin.
6. Patient has a concurrent medical or psychological condition that, in the
investigator's opinion, may compromise the patient's ability to participate in the
study or give informed consent, or may complicate the evaluations of the study drug.
7. Patient is receiving another investigational treatment for IPF at screening and/or
plans to receive an investigational treatment for IPF during the current study.
8. Patient has chronic hepatitis or significantly elevated liver enzyme levels, defined
as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 × upper
limit of normal (ULN) or total bilirubin above ULN.
9. Female patient who is pregnant, breast-feeding, or planning a pregnancy during the
course of the study.
10. Woman of childbearing potential who is unwilling to use adequate birth control
throughout the duration of the study.
11. Patient has participated in an investigational clinical trial during the last 4 weeks.