Influence of Bosentan on the Pharmacokinetics of Nintedanib

Phase 1

Completed

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

• Registration Number: NCT02667704
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The trial was designed to investigate whether, and to which extent, multiple doses of bosentan may influence the plasma levels of nintedanib administered as a single dose.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-21
• Study First Submitted QC: 2016-01-28
• Study First Posted: 2016-01-29
• Study Start: 2016-02
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2017-03
• Results First Submitted: 2017-03-02
• Results First Submitted QC: 2017-03-02
• Last Update Submitted: 2017-03-02
• Results First Posted: 2017-04-13
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nintedanib	Nintedanib	-
Bosentan	Bosentan	-

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve of Nintedanib in Plasma Over the Time Interval From 0 to the Last Quantifiable Concentration (AUC0-tz)	Up to 216 hours. The details are mentioned in description.	Area under the concentration-time curve of Nintedanib in plasma over the time interval from 0 to the last quantifiable concentration (AUC0-tz). PK plasma samples were taken at: 1 hour (h) before drug administration (approximate time for predose sample) and 30 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 144.5h, 145h, 145.5h, 146h, 146.5h, 147h, 148h, 149h, 150h, 152h, 154h, 156h, 168h, 180h, 192h, 216h after drug administration. Two different visits; Visit 2 (R): -1 to 72 h, Visit 3 (T) 144 to 216 h. AUC0-tz was calculated for each visit separately.
Maximum Measured Concentration of Nintedanib in Plasma (Cmax)	Up to 216 hours. The details are mentioned in description.	Maximum measured concentration of Nintedanib in plasma (Cmax). PK plasma samples were taken at: 1 hour (h) before drug administration and 30 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 144.5h, 145h, 145.5h, 146h, 146.5h, 147h, 148h, 149h, 150h, 152h, 154h, 156h, 168h, 180h, 192h, 216h after drug administration. Two different visits; Visit 2 (R): -1 to 72 h, Visit 3 (T) 144 to 216 h. Cmax was determined for each visit separately.

Secondary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve of Nintedanib in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)	Up to 216 hours. The details are mentioned in description.	Area under the concentration-time curve of Nintedanib in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity). PK plasma samples were taken at: 1 hour (h) before drug administration and 30 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 144.5h, 145h, 145.5h, 146h, 146.5h, 147h, 148h, 149h, 150h, 152h, 154h, 156h, 168h, 180h, 192h, 216h after drug administration. Two different visits; Visit 2 (R): -1 to 72 h, Visit 3 (T) 144 to 216 h. AUC0-infinity was calculated for each visit separately.

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany