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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Other: high fat meal; Other: low fat meal; Drug: BIIL 284 BS

Study type: Interventional

Funder types: Industry

Identifiers

NCT02273427

543.5

Details and patient eligibility

About

food effect, relative bioavailability, pharmacokinetics, safety and tolerability

Enrollment: 24 patients

Sex: Male

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

BIIL 284 BS fasted

Active Comparator group

Treatment:

Drug: BIIL 284 BS

BIIL 284 BS with high fat meal

Experimental group

Treatment:

Other: high fat meal

Drug: BIIL 284 BS

BIIL 284 BS with low fat meal

Experimental group

Treatment:

Drug: BIIL 284 BS

Other: low fat meal