Effect of Different Food Compositions on Bioavailability of BIIL 284 BS in Healthy Male Volunteers

NCT ID: NCT02273427

Last Updated: 2014-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-02-29

Brief Summary

food effect, relative bioavailability, pharmacokinetics, safety and tolerability

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BIIL 284 BS fasted

Group Type: ACTIVE_COMPARATOR

BIIL 284 BS

Intervention Type: DRUG

BIIL 284 BS with high fat meal

Group Type: EXPERIMENTAL

BIIL 284 BS

Intervention Type: DRUG

high fat meal

Intervention Type: OTHER

BIIL 284 BS with low fat meal

Group Type: EXPERIMENTAL

BIIL 284 BS

Intervention Type: DRUG

low fat meal

Intervention Type: OTHER

Interventions

BIIL 284 BS

Intervention Type: DRUG

high fat meal

Intervention Type: OTHER

low fat meal

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• All participants in the study should be healthy caucasian males as determined by the results of screening, range from 21 to 50 years of age and be within +- 20% of their normal weight (Broca-Index)
• All volunteers will have given their written informed consent in accordance with Good Clinical Practice and local legislation prior to admission to the study

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
• 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 to the trial as judged by the investigator
• Intake of drugs with a long half-life (> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study
• Use of any drugs which might influence the results of the trial (<= one week prior to administration or during the trial)
• Participation in another trial with an investigational drug (<= two months prior to administration or during the 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 (>= 100 ml within four weeks prior to administration or during the trial)
• Excessive physical activities (within the last week before the study)
• Any laboratory value outside the reference range of clinical relevance

• Minimum Eligible Age: 21 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

543.5

Identifier Type: -

Identifier Source: org_study_id