NCT02579603

Safety, Tolerability and PK of Nintedanib in Combination With Pirfenidone in IPF

A Twelve Week, Open-label, Randomised, Parallel-group Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Oral Nintedanib in Combination With Oral Pirfenidone, Compared to Treatment With Nintedanib Alone, in Patients With Idiopathic Pulmonary Fibrosis (IPF)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This is a phase IV, twelve week, open label, randomized, parallel group study to assess safety and tolerability of combined treatment with nintedanib and pirfenidone. A secondary objective is to assess the exposure based on PK trough concentration values to nintedanib either given alone or in combination with pirfenidone and to assess the exposure of pirfenidone when combined with nintedanib.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	Nintedanib	Nintedanib 150mg bid
DRUG	Pirfenidone

Timeline

• Start date: 2015-10-16
• Primary completion: 2017-01-03
• Completion: 2017-01-31
• First posted: 2015-10-19
• Last updated: 2018-02-13
• Results posted: 2018-02-13

Locations

23 sites across 6 countries: United States, Canada, France, Germany, Italy, Netherlands