Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C]-BI 207127 in Healthy Male Volunteers
Condition: Healthy
Intervention: BI 207127 NA
Intervention description: Single oral solution dose of BI 207127 NA combined with [14C]-BI 207127 NA
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility 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)