Investigation of Drug-drug Interaction of Nintedanib and Ketoconazole in Healthy Male Volunteers
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ClinicalTrials.gov Identifier: NCT01679613 |
Recruitment Status :
Completed
First Posted : September 6, 2012
Results First Posted : November 27, 2014
Last Update Posted : November 27, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Nintedanib Drug: Ketoconazole | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 34 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Relative Bioavailability of Nintedanib Given Alone and in Combination With Ketoconazole at Steady State in Healthy Male Volunteers (an Open-label, Randomised, Two-way Cross-over Clinical Phase I Study) |
Study Start Date : | September 2012 |
Actual Primary Completion Date : | November 2012 |
Actual Study Completion Date : | November 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 Nintedanib (Reference)
single dose, oral with 240 ml water
|
Drug: Nintedanib
low dose oral administration |
Experimental: 2 Nintedanib + Ketoconazole (Test)
Nintedanib single dose, Ketoconazole steady state, oral with 240 ml water
|
Drug: Ketoconazole
oral administration Drug: Nintedanib low dose oral administration |
Experimental: 3 Nintedanib (Reference)
single dose, oral with 240 ml water
|
Drug: Nintedanib
low or medium dose depending on pilot part |
Experimental: 4 Nintedanib + Ketoconazole (Test)
Nintedanib single dose, Ketoconazole steady state, oral with 240 ml water
|
Drug: Nintedanib
low or medium dose depending on pilot part Drug: Ketoconazole oral administration |
- Area Under the Curve From 0 Extrapolated to Infinity (AUC0-∞) [ Time Frame: 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
- Maximum Measured Concentration (Cmax) [ Time Frame: 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 to the Last Quantifiable Concentration (AUC0-tz) [ Time Frame: 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

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
1. healthy male subjects
Exclusion criteria:
1. Any relevant deviation from healthy conditions

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679613
Germany | |
1199.161.1 Boehringer Ingelheim Investigational Site | |
Biberach, Germany |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Boehringer Ingelheim |
ClinicalTrials.gov Identifier: | NCT01679613 |
Other Study ID Numbers: |
1199.161 2012-001009-26 ( EudraCT Number: EudraCT ) |
First Posted: | September 6, 2012 Key Record Dates |
Results First Posted: | November 27, 2014 |
Last Update Posted: | November 27, 2014 |
Last Verified: | November 2014 |
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