Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C]-BI 207127 in Healthy Male Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01605461
First received: May 9, 2012
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

Phase 1 study to assess the pharmacokinetics and routes of elimination of a single oral dose of [14C]-BI 207127 and to characterize the metabolic profile following single dose administration.


Condition Intervention Phase
Healthy
Drug: BI 207127 NA
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Metabolite Profile, Excretion Balance and Pharmacokinetics of BI 207127 NA Combined With [14C]-BI 207127 NA in Healthy Adult Male Volunteers After an 800 mg Single Oral Solution Dose; a Phase I, Single-arm, Open-label Trial

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Plasma BI 207127 AUC0-infinity (area under the analyte concentration-time curve over the time interval from 0 h extrapolated to infinity) [ Time Frame: 96 hours ] [ Designated as safety issue: No ]
  • Plasma BI 207127 Cmax (maximum measured concentration of the analyte) [ Time Frame: 96 hours ] [ Designated as safety issue: No ]
  • t1/2 (terminal half-life) of [14C]-radioactivity in plasma [ Time Frame: 96 hours ] [ Designated as safety issue: No ]
  • Excretion balance of total [14C]-radioactivity [ Time Frame: 216 hours ] [ Designated as safety issue: No ]
  • Excretion of total [14C]-radioactivity in urine [ Time Frame: 216 hours ] [ Designated as safety issue: No ]
  • Excretion of total [14C]-radioactivity in faeces [ Time Frame: 216 hours ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: May 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 207127 NA
Single oral solution dose of BI 207127 NA combined with [14C]-BI 207127 NA
Drug: BI 207127 NA
Single oral solution dose of BI 207127 NA combined with [14C]-BI 207127 NA

  Eligibility

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

Inclusion criteria:

  • Body mass index =18.5 and BMI = 29.9 kg/m2
  • Subject is willing to avoid sun exposure from the first administration of the trial drug until the end of the study
  • Male subjects must agree to minimise the risk of female partners becoming pregnant from the dosing day until three months after the completion of the study. Acceptable methods of contraception for male volunteers include a vasectomy no less than three months prior to dosing or barrier contraception. For female partners of male volunteers, acceptable methods of contraception include intra-uterine device, tubal ligation, or hormonal contraceptive for at least three months, or diaphragm with spermicide.
  • Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.

Exclusion criteria:

  • Participation in more than one other radiolabelled investigational study drug trial within 12 months prior to check-in. The previous radiolabelled study drug must have been received more than 6 months prior to check-in for this study and the total exposure from this study and the previous study will be within the recommended levels considered safe, per 21 CFR 361.1 (eg. less than 5,000 mrem whole body annual exposure)
  • Exposure to significant radiation (eg. serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) within 12 months prior to check-in
  • Participation in another trial with an investigational drug within two months prior to administration of the trial drug or during the trial
  • Use of drugs which might reasonably influence the results of the trial, including use of a broad spectrum antibiotic, within 10 days prior to administration of investigational medication in this trial or during the trial
  • Intake of a drug with a half-life of >24 hours within the month prior to administration of trial medication, or if administration of trial medication would occur in the time period in which fewer than 10 half-lives had elapsed
  • Surgery of the gastrointestinal tract (except appendectomy or cholecystectomy)
  • Current smoker or smoker in last six months; alcohol abuse (more than 40 g/day); history of illicit drug abuse within the past 2 years
  • Blood donation (more than 100 mL within four weeks prior to first administration of the trial drug or during the trial)
  • A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms); a history of additional risk factors for torsades de pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
  • History of photosensitivity or recurrent rash
  • Irregular defecation pattern (less than one bowel movement a day)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01605461

Locations
United States, Wisconsin
1241.22.001 Boehringer Ingelheim Investigational Site
Madison, Wisconsin, United States
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01605461     History of Changes
Other Study ID Numbers: 1241.22
Study First Received: May 9, 2012
Last Updated: December 12, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 16, 2014