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Metabolism and Pharmacokinetics of [14C]-BIBF 1120 in Healthy Male Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02182154
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 18, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE July 2, 2014
First Posted Date  ICMJE July 8, 2014
Last Update Posted Date July 18, 2014
Study Start Date  ICMJE October 2005
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2014)
  • [14C]-radioactivity in plasma and whole blood (C Blood cells/C plasma ratio of [14C]-radioactivity) [ Time Frame: Up to 96 h after drug administration ]
  • [14C]-radioactivity in urine [ Time Frame: Up to 120 h after drug administration ]
  • Measurement of the plasma protein binding of total [14C]-radioactivity in human plasma samples ex vivo [ Time Frame: Up to 96 h after drug administration ]
  • Maximum observed concentration of the analyte in plasma (Cmax) [ Time Frame: Up to 96 h after drug administration ]
  • Plasma concentration-time profiles of total radioactivity in whole blood and plasma [ Time Frame: Up to 96 h after drug administration ]
  • [14C]-metabolic profile and identification of metabolites in urine, in comparison with various animal species [ Time Frame: Up to 120 h after drug aministration ]
  • [14C]-radioactivity in faeces [ Time Frame: up to 120 h after administration ]
  • [14C]-metabolic profile and identification of metabolites in faeces, in comparison with various animal species [ Time Frame: Up to 120 h after drug aministration ]
  • [14C]-metabolic profile and identification of metabolites in plasma, in comparison with various animal species [ Time Frame: Up to 96 h after drug aministration ]
  • Time from dosing to peak concentration (tmax) [ Time Frame: Up to 96 h after drug administration ]
  • Terminal half-life of the analyte in plasma (t1/2) [ Time Frame: Up to 96 h after drug administration ]
  • Terminal rate constant of the analyte in plasma (λz) [ Time Frame: Up to 96 h after drug administration ]
  • Area under the concentration-time curve of the analyte in plasma from zero time to 24 hours (AUC0-24) [ Time Frame: Up to 24 h after drug administration ]
  • Area under the concentration-time curve of the analyte in plasma from zero time to the time of the last quantifiable drug concentration (AUC0-tz) [ Time Frame: Up to 96 h after drug administration ]
  • Area under the concentration-time curve of the analyte in plasma from zero time to infinity (AUC0-∞) [ Time Frame: Up to 96 h after drug administration ]
  • Mean residence time of the analyte molecules in the body after oral administration (MRTpo) [ Time Frame: Up to 96 h after drug administration ]
  • Total clearance of the analyte in plasma following extravascular administration (CL/F) [ Time Frame: Up to 96 h after drug administration ]
  • Apparent volume of distribution during the terminal phase λz following extravascular administration (Vz/F) [ Time Frame: Up to 96 h after drug administration ]
  • Fraction of analyte eliminated in urine from 0 to the limit of the last quantifiable data point (fe0-tz) [ Time Frame: Up to 96 h after drug administration ]
  • Fraction of analyte eliminated in faeces from 0 to the limit of the last quantifiable data point (fe faeces,0-tz) [ Time Frame: Up to 96 h after drug administration ]
  • Amount of analyte that was eliminated in faeces from 0 to the limit of the last quantifiable data point (Ae faeces,0-tz) [ Time Frame: Up to 96 h after drug administration ]
  • Amount of analyte that was eliminated in urine from 0 to the limit of the last quantifiable data point (Ae0-tz) [ Time Frame: Up to 96 h after drug administration ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2014)
  • Change from baseline in vital signs [ Time Frame: Baseline, day 14 after drug administration ]
  • Change from baseline in routine laboratory [ Time Frame: Baseline, day 14 after drug aministration ]
  • Number of participants with adverse events [ Time Frame: Up to day 14 after drug aministration ]
  • Change from baseline in electrocardiogram [ Time Frame: Baseline, day 14 after drug aministration ]
  • Assessment of tolerability by investigator according a 4 point scale [ Time Frame: Day 14 after drug administration ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Metabolism and Pharmacokinetics of [14C]-BIBF 1120 in Healthy Male Volunteers
Official Title  ICMJE Metabolism and Pharmacokinetics of [14C]-BIBF 1120 After Administration of Single Doses of 100 mg [14C]-BIBF 1120 Oral Solution in Healthy Male Volunteers
Brief Summary

To assess the metabolic profile,

to obtain the mass balance after oral administration,

to determine the concentration of [14C]-radioactivity in blood cells, plasma, urine and faeces,

to determine BIBF 1120 and BIBF 1202 concentrations in plasma, urine, and faeces, if feasible,

to determine the protein binding of [14C]-radioactivity,

to determine the pharmacokinetics of BIBF 1120, BIBF 1202 and total radioactivity after a single oral administration of [14C]-BIBF 1120 in healthy volunteers

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Drug: BIBF 1120 ES
Study Arms  ICMJE Experimental: BIBF 1120 ES
Intervention: Drug: BIBF 1120 ES
Publications * Not Provided

*   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: July 2, 2014)
8
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy male subjects as determined by results of screening
  2. Signed written informed consent in accordance with GCP and local legislation
  3. Age ≥21 and ≤55 years
  4. Body Mass Index ≥18.5 kg/m2 and ≤29.9 kg/m2

Exclusion Criteria:

  1. Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
  2. History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
  3. History of any major surgery within the last four weeks before participation in this study or any bone fracture within the last two months
  4. History of orthostatic hypotension, fainting spells and blackouts
  5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
  6. Chronic or relevant acute infections
  7. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  8. History of any bleeding disorder including prolonged or habitual bleeding, other haematologic disease or cerebral bleeding (e.g. after a car accident) or commotio cerebri
  9. Intake of drugs with a long half-life (> 24 hours) within 1 month prior to administration
  10. Planned use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
  11. Participation in another trial with an investigational drug within 2 months prior to administration or during trial
  12. Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
  13. Alcohol abuse (> 60 g/day)
  14. Drug abuse
  15. Blood donation within 1 month prior to administration or during the trial
  16. Excessive physical activities within 5 days prior to administration or during the trial
  17. Any laboratory value outside the reference range, unless considered to lack clinical reference
  18. Female gender
  19. Male subjects must agree to minimize the risk of female partners becoming pregnant from the dosing day until 3 months after the completion of the study. Acceptable methods of contraception for male volunteers include a vasectomy no less than 3 months prior to dosing, barrier contraception or a medically accepted contraceptive method. For female partners of male volunteers, acceptable methods of contraception include intra-uterine device, tubal ligation, hormonal contraceptive since at least two months and diaphragm with spermicide
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 21 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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02182154
Other Study ID Numbers  ICMJE 1199.20
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 Not Provided
PRS Account Boehringer Ingelheim
Verification Date July 2014

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