NCT Number: NCT02273427
Effect of Different Food Compositions on Bioavailability of BIIL 284 BS in Healthy Male Volunteers
food effect, relative bioavailability, pharmacokinetics, safety and tolerability
Looking for future studies?
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 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
Treatment and study plan
high fat meal
Otherlow fat meal
OtherPrimary outcomes
-
Maximum concentration (Cmax)
Time frame: up to 72 hours after drug administration
-
Area under the concentration time curve from timepoint zero extrapolated to infinity (AUC-infinity)
Time frame: up to 72 hours after drug administration
Secondary outcomes
-
Time to Cmax (tmax)
Time frame: up to 72 hours after drug administration
-
Area under the concentration time curve from timepoint zero to time of last data point above limit of quantification (AUC-tz)
Time frame: up to 72 hours after drug administration
-
Terminal half-life (t1/2)
Time frame: up to 72 hours after drug administration
-
Total mean residence time (MRTtot)
Time frame: up to 72 hours after drug administration
-
Volume of distribution during terminal phase after oral administration (Vz/F)
Time frame: up to 72 hours after drug administration
-
Total clearance after oral administration (CLtot/F)
Time frame: up to 72 hours after drug administration
-
Number of subjects with adverse events
Time frame: up to 8 days after last drug administration
-
Number of subjects with clinically significant findings in vital functions
Time frame: up to 8 days after last drug administration
blood pressure, pulse rate, ECG
-
Number of subjects with clinically significant findings in laboratory tests
Time frame: up to 8 days after last drug administration
Sponsors and collaborators
Lead sponsor
Boehringer Ingelheim
Industry
Registry information
Official study title
Randomised 3-way Cross-over Phase I Study to Investigate the Effect of Different Food Compositions (Low Fat and High Fat Meal) on Bioavailability of BIIL 284 BS 75 mg Tablet in Healthy Male Volunteers
Important dates
- Study start
- 2000
- Primary completion
- 2000
- 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.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Tumor-Derived FGF19
NCT06068257
Breast Cancer, Breast Diseases
Orlando, Florida, United States
View Trial DetailsAI Chatbot for HPV Vaccine Literacy Among Caregivers in Japan
NCT06702423
Healthy
London, United Kingdom
View Trial DetailsValidation of the Masimo Irregular Heartbeat Detection Algorithm in Participants Without Cardiovascular Disease
NCT07223164
Healthy
Irvine, California, United States
View Trial DetailsNormative Value for Navicular Drop Test in Older Adults
NCT05595902
Healthy
Kadıköy, Istanbul, Turkey (Türkiye)
View Trial Details