Safety, Pharmacokinetics and Pharmacodynamics of BIRB 796 BS Tablets Administered to Healthy Human Subjects

NCT ID: NCT02211157

Last Updated: 2014-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-03-31

Brief Summary

Study to assess safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating multiple doses with and without a 64 g fat breakfast at the 50 mg dose level

Conditions

Healthy

Study Design

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

Study Groups

BIBR 796 BS, fasted

dose escalation

Group Type: EXPERIMENTAL

BIBR 796 BS

Intervention Type: DRUG

BIBR 796 BS, fed

50 mg BIRB 796 BS (food effect)

Group Type: EXPERIMENTAL

BIBR 796 BS

Intervention Type: DRUG

high fat breakfast

Intervention Type: OTHER

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

BIBR 796 BS

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

high fat 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 and local legislation
• Age ≥ 18 and ≤ 45 years
• Broca ≥ - 20% and ≤ + 20%

Exclusion Criteria

• Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
• Surgery of gastrointestinal tract (except appendectomy)
• History of orthostatic hypotension, fainting spells and blackouts
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• 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) within 1 month prior to administration or during the trial)
• Use of any drugs which might influence the results of the trial within 10 days prior to administration or during trial
• Participation in another trial with an investigational drug within 2 months prior to administration or during trial
• Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day)
• Inability to refrain from smoking on study days
• Alcohol abuse (> 60 g/day)
• Drug abuse
• Blood donation > 400 ml within 1 month prior to administration or during the trial
• Excessive physical activities within 5 days prior to administration or during the trial
• Any laboratory value outside the reference range of clinical relevance including, but not limited to total white cell count ≥ 10 x 10**9/L, C-reactive protein ≥ 4.5 mg/L, Gamma-Glutamyl Transferase ≥ 40 U/L, any hemoglobin or > 15 mg/dl protein or urine dipstick, abnormal Multitest® assessment of cellular immunity
• History of any familial bleeding disorder
• Inability to comply with dietary regimen of study centre

• 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

1175.3

Identifier Type: -

Identifier Source: org_study_id