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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01679613
First received: September 3, 2012
Last updated: November 26, 2014
Last verified: November 2014
  Purpose

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 Intervention Phase
Healthy
Drug: Nintedanib
Drug: Ketoconazole
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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:
  • 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 ] [ Designated as safety issue: No ]

    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



Enrollment: 34
Study Start Date: September 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

1. healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01679613

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

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01679613     History of Changes
Other Study ID Numbers: 1199.161, 2012-001009-26
Study First Received: September 3, 2012
Results First Received: November 14, 2014
Last Updated: November 26, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Additional relevant MeSH terms:
Ketoconazole
Nintedanib
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014