Metabolism and Pharmacokinetics of [14C]-BIBR 953 ZW After Administration of Single Doses of [14C]-BIBR 953 ZW Intravenously or [14C]-BIBR 1048 Oral Solution in Healthy Male Volunteers

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: BIBR 1048 Oral Solution

Drug: BIBR 953 ZW Intravenously

Study type

Interventional

Funder types

Industry

Identifiers

NCT02171442

1160.6

Details and patient eligibility

About

The aim of this study were to investigate the metabolism and pharmacokinetics of BIBR 1048 MS and BIBR 953 ZW in man.

Enrollment

10 patients

Sex

Male

Ages

30 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male subjects as determined by results of screening
Signed written informed consent from each subject in accordance with the regulatory and legal requirements of the UK
Age between 30 and 55 years of age
Body Mass Index (BMI) of between 18.5 and 29.9 kg/m²

Exclusion criteria

Any of the findings from the medical examination (including BP, pulse rate and ECG) deviated from normal or were of clinical relevance
History of current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
History of relevant orthostatic hypotension, fainting spells and blackouts, or volunteers with diseases of the central nervous system (such as epilepsy) or psychiatric disorders
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
Chronic or relevant acute infections
History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the principal investigator
History of any bleeding disorder including prolonged or habitual bleeding
History of other hematologic disease
History of cerebral bleeding (e.g. after a car accident)
History of craniocerebral trauma
Intake of drugs with a long half life (≥ 24h) within 1 month prior to administration
Any drugs which may have had an influence on the results of the trial within 10 days prior to administration or during the trial
Any volunteers who had participated in another trial with an investigational drug within 3 months ( 4 months if the drug was a new chemical entity) prior to administration or during the trial
Exposition to radiation in the previous 12 months (i.e. serial x-rays, CT scan or barium meal)
Smoker
Alcohol abuse (> 60 g/day)
Drug abuse
Blood donation within 12 weeks prior to administration or during the trial
Any excessive physical activities within 5 days prior to administration or during the trial
Any laboratory value outside the clinically accepted reference range
History of familial bleeding disorder
Platelets > 150 x 10-9 /l
Unable to defecate at least once a day every two days