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: May 15, 2013
Last verified: May 2013
  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 concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity [ Time Frame: up to 72 h postdose ] [ Designated as safety issue: No ]
  • Maximum measured concentration of the analyte in plasma [ Time Frame: up to 72 h postdose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration [ Time Frame: up to 72 h postdose ] [ Designated as safety issue: No ]

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
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

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
Last Updated: May 15, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 16, 2014