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A Phase 2 Study to Evaluate the Safety and Tolerability of PBI-4050 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02538536
Recruitment Status : Completed
First Posted : September 2, 2015
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Liminal BioSciences Ltd.

Tracking Information
First Submitted Date  ICMJE August 25, 2015
First Posted Date  ICMJE September 2, 2015
Last Update Posted Date April 17, 2019
Study Start Date  ICMJE July 2015
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2016)
Number of subjects with abnormal laboratory values and/or adverse events that are related to treatment [ Time Frame: 4 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 29, 2015)
Number of subjects with abnormal laboratory values and/or adverse events that are related to treatment [ Time Frame: 9 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2016)
  • Change from baseline on pulmonary function tests [ Time Frame: 3 months ]
  • Change from baseline in imaging of thorax [ Time Frame: 3 months ]
  • Change from baseline on biomarkers [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2015)
  • Change from baseline on pulmonary function tests [ Time Frame: 9 months ]
  • Change from baseline in imaging of thorax [ Time Frame: 9 months ]
  • Change from baseline on biomarkers [ Time Frame: 9 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Study to Evaluate the Safety and Tolerability of PBI-4050 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Official Title  ICMJE A Phase 2, Open-label, Single Arm, Exploratory, Observational Study to Evaluate the Safety and Tolerability of PBI-4050 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Brief 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.
Detailed Description

This Phase 2 multi-centre study will be performed by 6 Canadian sites. It is an open-label, single-arm study in patients with Idiopathic Pulmonary Fibrosis (IPF) aged 40 years and older.

The duration of study participation is approximately 20 weeks for each patient and comprises 6 study visits.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Pulmonary Fibrosis (IPF)
Intervention  ICMJE Drug: PBI4050
Study Arms  ICMJE Experimental: PBI4050
Four 200 mg capsules (total 800 mg) administered orally, once daily.
Intervention: Drug: PBI4050
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 27, 2016)
41
Original Estimated Enrollment  ICMJE
 (submitted: August 29, 2015)
40
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02538536
Other Study ID Numbers  ICMJE PBI-4050-ATX-9-03
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Liminal BioSciences Ltd.
Study Sponsor  ICMJE Liminal BioSciences Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Liminal BioSciences Ltd.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP