NCT02209831CompletedPhase 1
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.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 22
- Primary Endpoint
- Area under the plasma concentration versus time curve from time 0 mathematically extrapolated to time infinity (AUC0-inf.)
Study Overview
Brief Summary
Study to assess the effect of gastric pH on the pharmacokinetics of BIRB 796 BS.
Safety and tolerability were also assessed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
- •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
Arms & Interventions
BIBR 796 BS + pantoprazole
Experimental
Intervention: BIBR 796 BS (Device)
BIBR 796 BS + pantoprazole
Experimental
Intervention: Pantoprazole (Drug)
BIBR 796 BS without pantoprazole
Active Comparator
Intervention: BIBR 796 BS (Device)
Outcomes
Primary Outcomes
Area under the plasma concentration versus time curve from time 0 mathematically extrapolated to time infinity (AUC0-inf.)
Time Frame: up to 36 hours after drug administration
Secondary Outcomes
- Area under the plasma concentration versus time curve over a given time interval (AUC0-t)(up to 36 hours after drug administration)
- Maximum observed plasma concentration (Cmax)(up to 36 hours after drug administration)
- Gastric pH measurements(up to 12 hours after drug administration)
- Number of patients with adverse events(up to 34 days)
- 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)
- Assessment of tolerability(on the last 1 day of second treatment)
Investigators
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