Bioavailability of Oral BIRB 796 BS Tablets With and Without Administration of Oral Pantoprazole in Healthy Male Volunteers

An Open Label, Randomised, Crossover Study of the Bioavailability of Oral BIRB 796 BS Tablets (30 mg Single Dose) With and Without Administration of Oral Pantoprazole in Healthy Male Volunteers to Assess the Effect of Gastric pH on Absorption of BIRB 796 BS.

Study to assess the effect of gastric pH on the pharmacokinetics of BIRB 796 BS.

Safety and tolerability were also assessed.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: BIBR 796 BS; Drug: Pantoprazole

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy male subjects as determined by results of screening
• Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
• Age >=18 and <=55 years
• Laboratory examinations within a clinically defined reference range
• Helicobacter pylori negative
• Able to tolerate pH probe application
• Body mass index (BMI) >=18.5 and <=29.9 kg/m2

Exclusion Criteria:

• Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
• Surgery of gastrointestinal tract (excluding appendectomy)
• History of orthostatic hypotension, fainting spells or blackouts
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological 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 including study drugs
• History of vasculitis (past history of fever, malaise, myalgias, rash, etc.)
• Intake of drugs with a long half-life (> 24 hours) within 1 month or 10 half lives of that drug, whichever is longer, prior to administration of study drugs or during the trial
• Use of any drugs that might influence the results of the trial within 10 days prior to administration or during the trial
• Use of grapefruit or grapefruit juice, alcohol, green tea, methylxanthine-containing products or tobacco within 5 days of study drug administration
• Participation in another trial with an investigational drug within 1 month prior to administration or during the trial
• Smoker
• Alcohol abuse (> 60 g/day)
• Drug abuse
• Blood or plasma donation (>400 ml) within 1 month prior to administration or during trial
• Excessive physical activities within 5 days prior to administration or during the trial
• Following specific laboratory findings: aspartate aminotransferase, alanine transaminase, Gamma-glutamyl-transferase above the reference range
• Inability to comply with dietary regimen of study centre
• Inability to comply with investigator's instructions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BIBR 796 BS + pantoprazole	Device: BIBR 796 BS; single dose; Drug: Pantoprazole; 5 days
Active Comparator: BIBR 796 BS without pantoprazole	Device: BIBR 796 BS; single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the plasma concentration versus time curve from time 0 mathematically extrapolated to time infinity (AUC0-inf.)	up to 36 hours after drug administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with adverse events		up to 34 days
Maximum observed plasma concentration (Cmax)		up to 36 hours after drug administration
Area under the plasma concentration versus time curve over a given time interval (AUC0-t)		up to 36 hours after drug administration
Time to the maximum plasma concentration (tmax)		up to 36 hours after drug administration
Apparent oral clearance (CL/F)		up to 36 hours after drug administration
Apparent volume of distribution during the terminal elimination phase, divided by F (bioavailability factor) (Vz/F)		up to 36 hours after drug administration
Elimination half-life (t1/2)		up to 36 hours after drug administration
Mean residence time (MRT)		up to 36 hours after drug administration
Gastric pH measurements		up to 12 hours after drug administration
Assessment of tolerability	based on the ability of the subjects to take the medicine as well as occurence of adverse events and abnormal laboratory investigations	on the last 1 day of second treatment

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: November 1, 2001
• Primary Completion (Actual): January 1, 2002

Study Registration Dates

• First Submitted: August 5, 2014
• First Submitted That Met QC Criteria: August 5, 2014
• First Posted (Estimate): August 6, 2014

Study Record Updates

• Last Update Posted (Estimate): August 6, 2014
• Last Update Submitted That Met QC Criteria: August 5, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Pantoprazole
• Other Study ID Numbers: 1175.17