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

NCT02209831 | Completed Phase 1

• 1 other identifier: 1175.17
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to assess the effect of gastric pH on the pharmacokinetics of BIRB 796 BS. Safety and tolerability were also assessed.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

Study Arms (2)

BIBR 796 BS + pantoprazole

EXPERIMENTAL

Device: BIBR 796 BS; Drug: Pantoprazole

BIBR 796 BS without pantoprazole

ACTIVE COMPARATOR

Device: BIBR 796 BS

Interventions

BIBR 796 BS DEVICE

single dose

BIBR 796 BS + pantoprazole; BIBR 796 BS without pantoprazole

Pantoprazole DRUG

5 days

BIBR 796 BS + pantoprazole

Eligibility Criteria

• Age: 18 Years - 55 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Related Links

• Related Info

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: August 5, 2014
• First Posted: August 6, 2014
• Study Start: November 1, 2001
• Primary Completion: January 1, 2002
• Last Updated: August 6, 2014

Record last verified: 2014-08