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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
Sponsor:
Information provided by (Responsible Party):
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

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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


  2. 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



Secondary Outcome Measures :
  1. 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
Criteria

Inclusion criteria:

1. healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions


Information from the National Library of Medicine

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


Locations
Germany
1199.161.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01679613     History of Changes
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

Additional relevant MeSH terms:
Ketoconazole
Nintedanib
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Antineoplastic Agents