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

NCT ID: NCT02184338

Last Updated: 2014-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31

Brief Summary

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

Conditions

Healthy

Study Design

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

Study Groups

BIRB 1017 BS in single rising doses

Group Type: EXPERIMENTAL

BIBR 1017 BS powder

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

PEG 400

Interventions

BIBR 1017 BS powder

Intervention Type: DRUG

Placebo

PEG 400

Intervention Type: DRUG

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 <= 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1187.1

Identifier Type: -

Identifier Source: org_study_id