Safety, Tolerability and PK of Nintedanib in Combination With Pirfenidone in IPF
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|ClinicalTrials.gov Identifier: NCT02579603|
Recruitment Status : Completed
First Posted : October 19, 2015
Results First Posted : February 13, 2018
Last Update Posted : February 13, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Pulmonary Fibrosis||Drug: Nintedanib Drug: Pirfenidone||Phase 4|
Expanded Access : Boehringer Ingelheim has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||105 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||October 16, 2015|
|Actual Primary Completion Date :||January 3, 2017|
|Actual Study Completion Date :||January 31, 2017|
Nintedanib 150 mg bid
Nintedanib 150mg bid
Experimental: Nintedanib and Pirfenidone
Nintedanib 150 mg bid combined with pirfenidone up to 801 mg tid
Nintedanib 150mg bid
Other Name: Pirfenidone 801 mg tid
- Percentage of Patients With On-treatment Gastrointestinal (GI) AEs (SOC GI Disorders) From Baseline to Week 12 [ Time Frame: Baseline to week 12 ]
Percentage of patients with on-treatment gastrointestinal (GI) Adverse events (AEs) (SOC GI disorders) from baseline to week 12.
On-treatment AEs were defined as AEs with an onset from the first dose of randomised treatment up to the last dose of randomised treatment (inclusive).
- Predose Plasma Concentrations at Steady State (Cpre,ss) of Nintedanib at Baseline, Weeks 2 and 4 [ Time Frame: baseline, prior to intake of study medication on week 2 and week 4 ]Predose plasma concentrations at steady state (Cpre,ss) of nintedanib at baseline (Visit 3), Week 2 (Visit 4) and Week 4 (Visit 5)
- Predose Plasma Concentrations at Steady State (Cpre,ss) of Pirfenidone [ Time Frame: Prior to intake of study medication on week 2 and week 4 ]Predose plasma concentrations at steady state (Cpre,ss) of pirfenidone at Week 2 (Visit 4) and Week 4 (Visit 5)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02579603
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|