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

NCT ID: NCT02171442

Last Updated: 2014-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-04-30

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BIBR 953 ZW Intravenously

Group Type: EXPERIMENTAL

BIBR 953 ZW Intravenously

Intervention Type: DRUG

5 mg, 2.8 MBq (76 µCi)

BIBR 1048 Oral Solution

Group Type: ACTIVE_COMPARATOR

BIBR 1048 Oral Solution

Intervention Type: DRUG

200 mg free base, 2.8 MBq (76 µCi)

Interventions

BIBR 953 ZW Intravenously

5 mg, 2.8 MBq (76 µCi)

Intervention Type: DRUG

BIBR 1048 Oral Solution

200 mg free base, 2.8 MBq (76 µCi)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 30 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

1160.6

Identifier Type: -

Identifier Source: org_study_id