Safety, Pharmacokinetics and Pharmacodynamics of Single Rising Doses Oral BIRB 796 BS in Healthy Human Subjects

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BIBR 796 BS; Other: high fat standardized breakfast; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02208856

1175.1

Details and patient eligibility

About

To assess safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating single doses, with and without a 64 g fat breakfast at one selected dose.

Enrollment: 64 patients

Sex: Male

Ages: 18 to 45 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 <= 45 years
• Broca >= -20% and <= +20%

Exclusion criteria

• Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological 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 ot 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 administration or during the trial)
• Participation in another trial with an investigational drug (=2 months prior to administration or during trial)
• Smoker (> 10 cigarettes of > 3 cigars of > 3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (> 60 g/day)
• Drug abuse
• Blood donation > 400 ml (=1 month prior to administration of during the trial)
• Excessive physical activities (= 5 days prior to administration or during the trial)
• Any laboratory value outside the reference range of clinical relevance (but not exclusive to) total white cell count >= 10 x 10**9/L, C-reactive protein >= 4.5 mg/L, any haemoglobin or > 15 mg/dl protein on urine dipstick
• History of any familial bleeding disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

BIBR 796 BS food effect

Experimental group

Treatment:

Drug: BIBR 796 BS

Other: high fat standardized breakfast

BIBR 796 BS

Experimental group

Treatment:

Drug: BIBR 796 BS