NCT02538536

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Liminal BioSciences Ltd. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Idiopathic Pulmonary Fibrosis (IPF)

Interventions

Type	Name	Description
DRUG	PBI4050

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2015-09-02
• Last updated: 2019-04-17

Locations

5 sites across 1 country: Canada