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Trial record 23 of 3115 for:    Area Under Curve AND Healthy

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

Tracking Information
First Submitted Date  ICMJE September 3, 2012
First Posted Date  ICMJE September 6, 2012
Results First Submitted Date  ICMJE November 14, 2014
Results First Posted Date  ICMJE November 27, 2014
Last Update Posted Date November 27, 2014
Study Start Date  ICMJE September 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2014)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: September 5, 2012)
  • 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 ]
  • Maximum measured concentration of the analyte in plasma [ Time Frame: up to 72 h postdose ]
Change History Complete list of historical versions of study NCT01679613 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2014)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2012)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation of Drug-drug Interaction of Nintedanib and Ketoconazole in Healthy Male Volunteers
Official Title  ICMJE 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)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Nintedanib
    low or medium dose depending on pilot part
  • Drug: Nintedanib
    low dose oral administration
  • Drug: Ketoconazole
    oral administration
Study Arms  ICMJE
  • Experimental: 1 Nintedanib (Reference)
    single dose, oral with 240 ml water
    Intervention: Drug: Nintedanib
  • Experimental: 2 Nintedanib + Ketoconazole (Test)
    Nintedanib single dose, Ketoconazole steady state, oral with 240 ml water
    Interventions:
    • Drug: Ketoconazole
    • Drug: Nintedanib
  • Experimental: 3 Nintedanib (Reference)
    single dose, oral with 240 ml water
    Intervention: Drug: Nintedanib
  • Experimental: 4 Nintedanib + Ketoconazole (Test)
    Nintedanib single dose, Ketoconazole steady state, oral with 240 ml water
    Interventions:
    • Drug: Nintedanib
    • Drug: Ketoconazole
Publications * Luedtke D, Marzin K, Jungnik A, von Wangenheim U, Dallinger C. Effects of Ketoconazole and Rifampicin on the Pharmacokinetics of Nintedanib in Healthy Subjects. Eur J Drug Metab Pharmacokinet. 2018 Oct;43(5):533-541. doi: 10.1007/s13318-018-0467-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 5, 2012)
34
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

1. healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01679613
Other Study ID Numbers  ICMJE 1199.161
2012-001009-26 ( EudraCT Number: EudraCT )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP