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)
Overview
- Phase
- Phase 4
- Intervention
- Nintedanib
- Conditions
- Idiopathic Pulmonary Fibrosis
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 105
- Locations
- 23
- Primary Endpoint
- Percentage of Patients With On-treatment Gastrointestinal (GI) AEs (SOC GI Disorders) From Baseline to Week 12
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Nintedanib
Nintedanib 150 mg bid
Intervention: Nintedanib
Nintedanib and Pirfenidone
Nintedanib 150 mg bid combined with pirfenidone up to 801 mg tid
Intervention: Nintedanib
Nintedanib and Pirfenidone
Nintedanib 150 mg bid combined with pirfenidone up to 801 mg tid
Intervention: Pirfenidone
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Predose Plasma Concentrations at Steady State (Cpre,ss) of Nintedanib at Baseline, Weeks 2 and 4(baseline, prior to intake of study medication on week 2 and week 4)
- Predose Plasma Concentrations at Steady State (Cpre,ss) of Pirfenidone(Prior to intake of study medication on week 2 and week 4)