Clinical trial NCT02211144 (phase 1, status: completed)
Conditions: healthy
ICD codes: Z76.3, Z76.2
Drugs: bibr 796 bs, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        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