Relative Bioavailability of a Single Dose of Nintedanib Given Alone and in Combination With Multiple Doses of Rifampicin

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Rifampicin; Drug: Nintedanib

• Registration Number: NCT01770392
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To investigate the effect of the P-gp inducer rifampicin on the pharmacokinetic parameters of nintedanib

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-15
• Study First Submitted QC: 2013-01-15
• Study First Posted: 2013-01-17
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2014-11
• Results First Submitted: 2014-11-14
• Results First Submitted QC: 2014-11-26
• Last Update Submitted: 2014-11-26
• Results First Posted: 2014-11-27
• Last Update Posted: 2014-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test	Rifampicin	multiple doses of Rifampicin + single dose of Nintedanib
Test	Nintedanib	multiple doses of Rifampicin + single dose of Nintedanib
Reference	Nintedanib	single dose of Nintedanib

Primary Outcome Measures

Name	Time	Method
Area Under the Curve From 0 Extrapolated to Infinity (AUC0-∞)	1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanib	AUC0-∞ represents the Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity.; For this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Maximum Measured Concentration (Cmax)	1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanib	Cmax represents the maximum concentration of nintedanib in plasma. For this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve From 0 to the Last Quantifiable Concentration (AUC0-tz)	1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanib	AUC0-tz represents the area under the plasma concentration-time curve of nintedanib from 0 to the last quantifiable analyte plasma concentration.; For this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

Trial Locations

Locations (1)

1199.162.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany