Clinical trial NCT02209831: Bioavailability of Oral BIRB 796 BS Tablets With and Without Administration of Oral Pantoprazole in Healthy Male Volunteers
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-08-06
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Safety and tolerability were also assessed.


Eligibility criteria: 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

Primary outcomes:
measure: Area under the plasma concentration versus time curve from time 0 mathematically extrapolated to time infinity (AUC0-inf.)
timeFrame: up to 36 hours after drug administration
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: up to 36 hours after drug administration
measure: Area under the plasma concentration versus time curve over a given time interval (AUC0-t)
timeFrame: up to 36 hours after drug administration
measure: Time to the maximum plasma concentration (tmax)
timeFrame: up to 36 hours after drug administration
measure: Apparent oral clearance (CL/F)
timeFrame: up to 36 hours after drug administration
measure: Apparent volume of distribution during the terminal elimination phase, divided by F (bioavailability factor) (Vz/F)
timeFrame: up to 36 hours after drug administration
measure: Elimination half-life (t1/2)
timeFrame: up to 36 hours after drug administration
measure: Mean residence time (MRT)
timeFrame: up to 36 hours after drug administration
measure: Gastric pH measurements
timeFrame: up to 12 hours after drug administration
measure: Number of patients with adverse events
timeFrame: up to 34 days
measure: Assessment of tolerability
timeFrame: on the last 1 day of second treatment
Other outcomes:
Locations:
Study officials:
References: