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

NCT ID: NCT02265302

Last Updated: 2014-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-06-30

Brief Summary

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

Conditions

Healthy

Study Design

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

Study Groups

BIIL 284 BS oral solution

Group Type: EXPERIMENTAL

BIIL 284 oral solution

Intervention Type: DRUG

BIIL 284 BS WIF tablets

Group Type: EXPERIMENTAL

BIIL 284 wetability improved formulation (WIF) tablets

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

BIIL 284 oral solution

Intervention Type: DRUG

BIIL 284 wetability improved formulation (WIF) tablets

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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)

• 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

543.1

Identifier Type: -

Identifier Source: org_study_id