Relative Bioavailability, Pharmacokinetics, Safety and Tolerability of BIIL 284 BS in Healthy Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Other: standard breakfast; Drug: BIIL 284 BS tablet C; Drug: BIIL 284 BS boli

Study type: Interventional

Funder types: Industry

Identifiers

NCT02265640

543.28

Details and patient eligibility

About

The objective of the present study is to investigate the relative bioavailability of BIIL 284 BS boli in comparison to the tablet C at a dose of 75 mg in fasted condition and after a standard breakfast in healthy male volunteers

Enrollment: 16 patients

Sex: Male

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All participants are healthy males
• Age range from 21 to 50 years
• Broca-Index: within +- 20% of normal weight

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 with psychiatric 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 a drug with a long half-life (> 24 hours) within one month or less than ten half-lives of the respective drug before enrollment 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 study with an investigational drug (>= tow months prior to administration or during the trial)
• Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day)
• Inability to refrain from smoking on study days
• Alcohol abuse (> 60g/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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16 participants in 4 patient groups

BIIL 284 BS boli - fasted

Experimental group

Treatment:

Drug: BIIL 284 BS boli

BIIL 284 BS boli - fed

Experimental group

Treatment:

Other: standard breakfast

Drug: BIIL 284 BS boli

BIIL 284 BS tablet C - fasted

Active Comparator group

Treatment:

Drug: BIIL 284 BS tablet C

BIIL 284 BS tablet C - fed

Active Comparator group

Treatment:

Other: standard breakfast

Drug: BIIL 284 BS tablet C