Investigation of Drug-drug Interaction of Nintedanib and Ketoconazole in Healthy Male Volunteers

Phase 1

Completed

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

• Registration Number: NCT01679613
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objective of the current study is to investigate the relative bioavailability of a single dose of nintedanib low or high dose with and without coadministration of ketoconazole at steady state

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-03
• Study First Submitted QC: 2012-09-05
• Study First Posted: 2012-09-06
• Primary Completion: 2012-11
• Study Completion: 2012-11
• 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: 34

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
3 Nintedanib (Reference)	Nintedanib	single dose, oral with 240 ml water
4 Nintedanib + Ketoconazole (Test)	Ketoconazole	Nintedanib single dose, Ketoconazole steady state, oral with 240 ml water
2 Nintedanib + Ketoconazole (Test)	Nintedanib	Nintedanib single dose, Ketoconazole steady state, oral with 240 ml water
1 Nintedanib (Reference)	Nintedanib	single dose, oral with 240 ml water
2 Nintedanib + Ketoconazole (Test)	Ketoconazole	Nintedanib single dose, Ketoconazole steady state, oral with 240 ml water
4 Nintedanib + Ketoconazole (Test)	Nintedanib	Nintedanib single dose, Ketoconazole steady state, oral with 240 ml water

Primary Outcome Measures

Name	Time	Method
Maximum Measured Concentration (Cmax)	1 hour (h) before drug administration and 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h and 72h after the drug administration	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
Area Under the Curve From 0 Extrapolated to Infinity (AUC0-∞)	1 hour (h) before drug administration and 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h and 72h after the drug administration	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

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve From 0 to the Last Quantifiable Concentration (AUC0-tz)	1 hour (h) before drug administration and 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h and 72h after the drug administration	AUC0-tz represents the area under the plasma concentration-time curve of nintedanib from time 0 to the last quantifiable nintedanib plasma concentration.; For this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities

Trial Locations

Locations (1)

1199.161.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany