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

NCT ID: NCT02208856

Last Updated: 2014-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-09-30

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

BIBR 796 BS food effect

Group Type: EXPERIMENTAL

BIBR 796 BS

Intervention Type: DRUG

high fat standardized breakfast

Intervention Type: OTHER

BIBR 796 BS

Group Type: EXPERIMENTAL

BIBR 796 BS

Intervention Type: DRUG

Interventions

BIBR 796 BS

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

high fat standardized breakfast

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1175.1

Identifier Type: -

Identifier Source: org_study_id