A Study to Compare the Amount of Nintedanib and Pirfenidone in the Blood When Nintedanib and Pirfenidone Are Given Separately or in Combination

Phase 4

Completed

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: Drug: nintedanib
Drug: pirfenidone

Registration Number: NCT02606877

Lead Sponsor: Boehringer Ingelheim

Brief Summary: The primary objective of this study is to investigate the effect of steady state pirfenidone on the pharmacokinetics of nintedanib and its metabolites following oral administration of 2403 mg/day pirfenidone and to investigate the effect of steady state nintedanib on the pharmacokinetics of pirfenidone at steady state following oral administration of 150 mg bid nintedanib. There will be two cohorts of patients; the first one will consist of patients not treated with pirfenidone or nintedanib, while the second one will consist of patients on pirfenidone treatment.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 37

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment naïve	pirfenidone	Treatment naïve to pirfenidone
Treatment naïve	nintedanib	Treatment naïve to pirfenidone
Pirfenidone-treated	nintedanib	Treatment before with pirfenidone
Pirfenidone-treated	pirfenidone	Treatment before with pirfenidone

Primary Outcome Measures

Name	Time	Method
Treatment naïve, Area Under the Concentration-time Curve of the Nintedanib in Plasma Over the Time Interval 0 to the Last Quantifiable Data Point (AUC0-tz).	Blood samples were collected at pre-dose and at 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00 and 10:00 hours post dose.	AUC0-tz , area under the concentration-time curve of nintedanib in plasma over the time interval from 0 to the last quantifiable concentration. Standard error mentioned in the Method of Dispersion is actually a Geometric Standard Error.
Treatment naïve, Maximum Measured Concentration of Nintedanib in Plasma After Single Dose Administration (Cmax).	Blood samples were collected at pre-dose and at 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00 and 10:00 hours post dose.	Cmax, maximum measured concentration of nintedanib in plasma. Standard error mentioned in the Method of Dispersion is actually a Geometric Standard Error.
Pirfenidone-treated, Area Under the Concentration-time Curve of Pirfenidone in Plasma Over a Dosing Interval at Steady State (AUCτ,ss)	Blood samples were collected at pre-dose and at 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00 and 10:00 hours post dose.	AUCτ,ss, area under the concentration-time curve of pirfenidone in plasma over a dosing interval at steady state. Standard error mentioned in the Method of Dispersion is actually a Geometric Standard Error.
Pirfenidone-treated, Maximum Measured Concentration of Pirfenidone in Plasma at Steady State (Cmax,ss)	Blood samples were collected at pre-dose and at 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00 and 10:00 hours post dose.	Cmax,ss, maximum measured concentration of pirfenidone in plasma at steady state. Standard error mentioned in the Method of Dispersion is actually a Geometric Standard Error.

Secondary Outcome Measures

Name	Time	Method
Treatment naïve, Area Under the Concentration-time Curve of Nintedanib in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	Blood samples were collected at pre-dose and at 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00 and 10:00 hours post dose.	AUC0-∞, area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity. Standard error mentioned in the Method of Dispersion is actually a Geometric Standard Error.

Trial Locations

Locations (9): Papworth Hospital
🇬🇧
Cambridge, United Kingdom
Glenfield Hospital
🇬🇧
Leicester, United Kingdom
Southmead Hospital
🇬🇧
Bristol, United Kingdom
University College London Hospital
🇬🇧
London, United Kingdom
Churchill Hospital
🇬🇧
Oxford, United Kingdom
Wythenshawe Hospital
🇬🇧
Manchester, United Kingdom
Southampton General Hospital
🇬🇧
Southampton, United Kingdom
Guy's Hospital
🇬🇧
London, United Kingdom
Royal Brompton Hospital
🇬🇧
London, United Kingdom