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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: BI 201335 NA soft gelatin capsule

Drug: [14C]-BI 201335 NA radiolabelled drug

Study type

Interventional

Funder types

Industry

Identifiers

NCT02182349

1220.33

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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)