NCT Number: NCT02273414
Study to Investigate the Safety, Tolerability, Biological Effects and Preliminary Pharmacokinetics of Increasing Doses of BIIL 284 BS in Healthy Male Volunteers
The objective of the present study is to obtain information about the safety and tolerability of BIIL 284 BS after repeated dosing, to find the pharmacologically active dose range by determination of the surrogate marker CD 11b (= Mac-1) and to obtain preliminary pharmacokinetic data concerning steady state and accumulation factor
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Notify MeKey information
Conditions
Age range
21 year–50 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- All participants are healthy males
- Age range from 21 to 50 years
- Broca-Index: within +- 20% of their normal weight
- In accordance with Good Clinical Practice (GCP) and local legislation each volunteer is supposed to give their written informed consent prior to admission to the study
Exclusion criteria
- Volunteers will be excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
- Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Volunteers with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
- Volunteers with history of orthostatic hypotension, fainting spells or blackouts
- Volunteers with chronic or relevant acute infections
- Volunteers with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Volunteers with eosinophilia > 7 %
- Volunteers who have taken 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 enrollment in the study
- Volunteers who received any drugs which might influence the results of the trial the week previous to the start of the study
- Volunteers who have participated in another study with an investigational drug within the last two months preceding this study
- Volunteers who smoke
- Volunteers who drink more than 60g of alcohol per day
- Volunteers who are dependent on drugs
- Volunteers who participated in excessive physical activities (e.g. competitive sports) within the last week before the study
- Volunteers who have donated blood within the last 4 weeks (>= 100 mL)
Treatment and study plan
Placebo
DrugPrimary outcomes
-
Number of subjects with adverse events
Time frame: up to 8 days after last drug administration
-
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to 8 days after last drug administration
-
Number of subjects with clinically significant changes in vital signs
Time frame: up to 8 days after last drug administration
Blood pressure, Pulse Rate, Respiratory Rate
-
Number of subjects with clinically significant changes in 12-lead electrocardiogram
Time frame: up to 8 days after last drug administration
Secondary outcomes
-
AUC0-24h (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours)
Time frame: up to 24 hours after drug administration
-
Cmax (Maximum measured concentration of the analyte in plasma)
Time frame: up to 80 hours after drug administration
-
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 80 hours after drug administration
-
t½ (Terminal half-life of the analyte in plasma)
Time frame: up to 80 hours after drug administration
-
MRTtot (Total mean residence time)
Time frame: up to 80 hours after drug administration
-
Vz/F (Apparent volume of distribution of the analyte during the terminal phase)
Time frame: up to 80 hours after drug administration
-
CLtot/F (Total clearance after oral administration)
Time frame: up to 80 hours after drug administration
-
Ae0-24h (Amount of analyte that is eliminated in urine from 0 to 24 hours)
Time frame: up to 24 hours after drug administration
-
AUCss (Area under the plasma concentration-time curve at steady state)
Time frame: up to 80 hours after drug administration
-
Cpre,ss (Predose concentration of the analyte in plasma at steady state)
Time frame: up to 80 hours after drug administration
-
Changes in Leucotriene B4 (LTB4) induced Mac-1 expression
Time frame: up to 24 hours after last treatment on day 9
Sponsors and collaborators
Lead sponsor
Boehringer Ingelheim
Industry
Registry information
Official study title
A Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Investigate the Safety, Tolerability, Biological Effects and Preliminary Pharmacokinetics of Increasing Repeated Oral Doses (9 Days Dosing) of BIIL 284 BS (Doses: 25 mg, 150 mg, 250 mg as WIF Tablets) in Healthy Male Volunteers
Important dates
- Study start
- 1999
- Primary completion
- 1999
- First posted
- Oct 24, 2014
- Registry last updated
- Oct 24, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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