Safety and Pharmacokinetics of BIRB 796 BS Tablets Administered Twice Daily Orally to Healthy Human Subjects

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: BIBR 796 BS

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02211144

1175.21

Details and patient eligibility

About

Study to assess the safety and pharmacokinetics of BIRB 796 BS tablets administered as multiple daily doses at various dose levels

Enrollment

120 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male or female subjects as determined by results of screening
Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
Female subjects who were not lactating and not of child bearing potential as defined by surgically sterile or post menopausal (no periods for at least 12 months and elevated follicle stimulating hormone (FSH) with low estradiol while on no estrogen supplementation). Females were to use barrier contraception (e.g. condoms) prior to administration of study medication, during the study and at least one month after release from the study. Women must have had negative blood pregnancy tests
Age ≥ 18 and ≤ 60 years
Body mass index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
Able to communicate well with the investigator and to comply with study requirements
Laboratory values within a clinically defined reference range

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 or hormonal disorders
Surgery of gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
History of orthostatic hypotension, fainting spells or blackouts
Chronic or relevant acute infections
History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
History of vasculitis (past history of fever, malaise, myalgias, rash, etc.)
Intake of drugs with a long half-life (> 24 hours) (< 1 month prior to administration or during the trial)
Use of any drugs, which might influence the results of the trial, (< 10 days prior to administration or during the trial)
Participation in another trial with an investigational drug (< 1 months prior to administration (at least 10 times the relevant elimination half-life) or during the trial)
Having had prescription medication 2 weeks prior to study drug administration or over the counter medication 1 week prior to study drug administration (at least 10 times the relevant elimination half-life)
Smoker
Alcohol abuse (> 60 g/day)
Drug abuse
Use of methylxanthine-containing drinks or foods (coffee, tea, cola, energy drinks, chocolate, etc.), grapefruit or grapefruit juice, alcohol, green tea, or tobacco < 5 days prior to administration of study drug
Blood donation or loss > 400 mL (< 1 month prior to administration or during the trial)
Excessive physical activities (< 5 days prior to administration or during the trial)
Following specific laboratory findings: white blood cell count, C-reactive protein, gamma-glutamyl-transferase, aspartate transaminase, alanine transaminase, or glutamate dehydrogenase above the normal range; any erythrocytes or > 15 mg/dl protein on urine dipstick if not menstruating
Any EKG value outside of the reference range of clinical relevance including, but not limited to QTcB > 480 ms or QRS interval > 110 ms
History of any familial bleeding disorder
Inability to comply with dietary regimen of study centre
Inability to comply with investigator's instructions