Safety, Tolerability, Biological Effects and Pharmacokinetics of BIIL 284 BS in Healthy Males

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Placebo

Drug: BIIL 284 wetability improved formulation (WIF) tablets

Drug: BIIL 284 oral solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT02265302

543.1

Details and patient eligibility

About

Study to obtain information about the safety and tolerability of BIIL 248 BS, to find the pharmacologically active dose range for the two formulations PSE 1% and WIF tablets by determination of the surrogate marker CD11b (= Mac-1) and to obtain preliminary pharmacokinetic data as well as first information on food effects after administration of the 75 mg WIF tablet in healthy male volunteers

Enrollment

95 patients

Sex

Male

Ages

21 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male subjects as determined by results of screening
Age ≥ 21 and ≤ 50 years
Broca ≥ - 20% and ≤ + 20%
Signed written informed consent in accordance with Good Clinical Practice and local legislation

Exclusion criteria

Results of the medical examination or laboratory tests that are judged by the clinical investigator to differ significantly from normal clinical values
Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
Known 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 at least one month or less than ten half-lives of the respective drug before enrolment in the study
Intake of any other drugs which might influence the results of the trial during the week previous to the start of the study
Participation in another study with an investigational drug within the last two months preceding this study
Smokers (> 5 cigarettes or 2 cigars or 2 pipes/day)
Volunteer who is not able to refrain from smoking on study days
Alcohol abuse (more than 60 g of alcohol per day)
Drug abuse
Excessive physical activities (e.g. competitive sports) within the last week before the study
Blood donation within the last 4 weeks (≥ 100 ml)