Metabolism and Pharmacokinetics of Oral Solution of [14C]-BI 201335 in Healthy Male Volunteers

NCT ID: NCT02182349

Last Updated: 2014-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30

Brief Summary

Study to determine the pharmacokinetics (PK) of BI 201335 and total radioactivity including excretion mass balance, excretion pathways and metabolism following the oral administration of [14C]-BI 201335 at steady state.

Conditions

Healthy

Study Design

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

Study Groups

BI 201335 NA

multiple doses of BI 201335 NA soft gelatin capsule on days 1-8 and 11-15 and one single dose of \[14C\]-BI 201335 NA radiolabelled drug on day 9

Group Type: EXPERIMENTAL

BI 201335 NA soft gelatin capsule

Intervention Type: DRUG

[14C]-BI 201335 NA radiolabelled drug

Intervention Type: DRUG

Interventions

BI 201335 NA soft gelatin capsule

Intervention Type: DRUG

[14C]-BI 201335 NA radiolabelled drug

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy males according to a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead ECG (electrocardiogram), and clinical laboratory tests
• Age 18 to 55 years, inclusive
• Body mass index 18.5 to 29.9 kg/m2, inclusive
• Nonsmoker
• Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation

Exclusion Criteria

• Any finding in the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• Any evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal, psychiatric or neurological disorders (including all forms of epilepsy)
• Surgery of the gastrointestinal tract (except appendectomy)
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Subjects with Gilbert's Syndrome
• Chronic or relevant acute infections
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• Intake of drugs with a long half-life (>24 hours) within one month prior to administration of the trial drug
• Use of prescription medication, over-the-counter drugs or herbal preparations within 14 days prior to administration of the trial drug
• Participation in another trial with an investigational drug within two months prior to administration of the trial drug or during the trial
• History or evidence of habitual tobacco or nicotine use within six months prior to administration of the trial drug
• Alcohol abuse (more than 2 ounces of alcohol/day)
• Drug abuse in opinion of investigator
• Blood donation (more than 100 mL within four weeks prior to administration of trial drug or during the trial)
• Excessive physical activity within five days prior to administration of trial drug
• Any laboratory value outside the reference range that is of clinical relevance
• Inability to comply with dietary regimen of trial centre
• marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
• 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, barrier contraception, or a medically accepted contraceptive method. For female partners of male volunteers, acceptable methods of contraception include intrauterine device, tubal ligation, hormonal contraceptive for at least two months, or diaphragm with spermicide
• Participation in more than one other radiolabelled investigational drug trial within one year prior to administration of the trial drug. The previous radiolabelled trial drug must have been received more than six months prior to administration of the trial drug for this study, and the total exposure from this study and the previous study will be within the recommended levels considered safe (e.g., less than 5000 mrem whole body annual exposure)
• 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

Other Identifiers

1220.33

Identifier Type: -

Identifier Source: org_study_id