Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BIRB 1017 BS as a Solution in PEG 400 / 26% Ethanol Administered to Healthy Male Subjects

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Placebo

Drug: BIBR 1017 BS powder

Study type

Interventional

Funder types

Industry

Identifiers

NCT02184338

1187.1

Details and patient eligibility

About

Study to assess safety, tolerability and pharmacokinetics of BIRB 1017 BS in single rising oral doses of 5 to 800 mg in a polyethylene glycol 400 (PEG 400) / 26% ethanol solution in healthy male subjects

Enrollment

48 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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 <= 50 years
BMI >18.5 and <29.9 kg/m2 (Body Mass Index)

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, haematological, oncological or hormonal disorders
Surgery of gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
Relevant 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
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 study drug administration or expected during the trial)
Participation in another trial with an investigational drug (< 2 months prior to administration or expected during trial)
Smoker (> 10 cigarettes or >3 cigars or >3 pipes/day)
Inability to refrain from smoking on trial days
Alcohol abuse (> 60 g/day)
Drug abuse
Blood donation or loss > 400 mL, < 1 month prior to administration or expected during the trial
Excessive physical activities (within 5 days prior to administration or during the trial)
Clinically relevant laboratory abnormalities
Any electrocardiogram value outside of the reference range and of clinical relevance including, but not limited to QRS interval > 110 ms or QTcB > 450 ms or QT >500 ms
Known hypersensitivity to the drug or its excipients
Inability to comply with dietary regimen of study centre
Inability to comply with investigator's instructions