Bioavailability of BIBR 953 ZW in Healthy Subjects

NCT02170766 | Completed Phase 1

• 1 other identifier: 1160.15
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess the extend of absorption of 12.5, 25, 50 and 100 mg of BIBR 1048 free base with and without coadministration of 40 mg pantoprazole.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUC0-inf (Area under the concentration-time curve the time interval from 0 extrapolated to infinity) of BIBR 953 ZW

  Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug

• AUC0-tf (Area under the concentration-time curve over the time interval from 0 to the time of the last quantifiable concentration) of BIBR 953 ZW

  Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug

Secondary Outcomes (8)

• Cmax (Maximum measured concentration) of BIBR 953 ZW

  Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug

• tmax (Time from dosing to the maximum concentration) of BIBR 953 ZW

  Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug

• MRTtot (Total mean residence time) of BIBR 953 ZW

  Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug

• CLtot/F (Total apparent clearance) of BIBR 953 ZW

  Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug

• Vz/F (Apparent volume of distribution) of BIBR 953 ZW

  Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug

Study Arms (4)

BIBR 1048 low1

EXPERIMENTAL

Two treatments of one single dose of BIBR 1048 12.5 mg without or with Pantoprazole 1. BIBR 1048 12.5 mg without Pantoprazole 2. BIBR 1048 12.5 mg with 40 mg Pantoprazole (bid)

Drug: BIBR 1048 low1; Drug: Pantoprazole

BIBR 1048 low2

EXPERIMENTAL

Two treatments of one single dose of BIBR 1048 25 mg without or with Pantoprazole 1. BIBR 1048 25 mg without Pantoprazole 2. BIBR 1048 25 mg with 40 mg Pantoprazole (bid)

Drug: BIBR 1048 low2; Drug: Pantoprazole

BIBR 1048 medium

EXPERIMENTAL

Two treatments of one single dose of BIBR 1048 50 mg without or with Pantoprazole 1. BIBR 1048 50 mg without Pantoprazole 2. BIBR 1048 50 mg with 40 mg Pantoprazole (bid)

Drug: BIBR 1048 medium; Drug: Pantoprazole

BIBR 1048 high

EXPERIMENTAL

Two treatments of one single dose of BIBR 1048 100 mg without or with Pantoprazole 1. BIBR 1048 100 mg without Pantoprazole 2. BIBR 1048 100 mg with 40 mg Pantoprazole (bid)

Drug: BIBR 1048 high; Drug: Pantoprazole

Interventions

BIBR 1048 low1 DRUG

BIBR 1048 low1

BIBR 1048 low2 DRUG

BIBR 1048 low2

BIBR 1048 medium DRUG

BIBR 1048 medium

BIBR 1048 high DRUG

BIBR 1048 high

Pantoprazole DRUG

BIBR 1048 high; BIBR 1048 low1; BIBR 1048 low2; BIBR 1048 medium

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects as determined by results of screening
• Signed written informed consent in accordance with GCP and local legislation
• Age ≥ 18 and ≤ 50 years
• Broca ≥ - 20% and ≤ + 20%

You may not qualify if:

• Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• History of current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
• History of orthostatic hypotension, fainting spells and blackouts
• 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 investigator
• Any bleeding disorder including prolonged or habitual bleeding
• Other hematologic disease
• Cerebral bleeding (e.g. after a car accident)
• Commotio cerebri
• Intake of drugs with a long half-life (\>24 hours) within 1 month prior to administration
• Use of any drugs which might influence the results of the trial within 10 days prior to administration or during trial
• Participation in another trial with an investigational drug within 2 months prior to administration or during trial
• Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Pantoprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 23, 2014
• Study Start: October 1, 2000
• Primary Completion: December 1, 2000
• Last Updated: June 23, 2014

Record last verified: 2014-06