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

NCT ID: NCT01605461

Last Updated: 2016-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2012-06-30

Brief 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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

BI 207127 NA

Single oral solution dose of BI 207127 NA combined with \[14C\]-BI 207127 NA

Group Type: EXPERIMENTAL

BI 207127 NA

Intervention Type: DRUG

Single oral solution dose of BI 207127 NA combined with \[14C\]-BI 207127 NA

Interventions

BI 207127 NA

Single oral solution dose of BI 207127 NA combined with \[14C\]-BI 207127 NA

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1241.22.001 Boehringer Ingelheim Investigational Site

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

1241.22

Identifier Type: -

Identifier Source: org_study_id