NCT02254538
Completed
Phase 1
A Double-blind (at Each Dose Level), Randomised, Placebo-controlled Single Increasing Dose Safety, Tolerability and Preliminary Pharmacokinetics Study in Healthy Male Volunteers After Oral Administration of BILR 355 BS Solved in PEG 400 (Dosage: 1 - 200 mg)
Overview
- Phase
- Phase 1
- Intervention
- BILR 355 BS
- Conditions
- Healthy
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 54
- Primary Endpoint
- Number of participants with clinically significant changes in vital functions
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
Assessment of safety, tolerability and preliminary pharmacokinetics in healthy male volunteers after oral administration of BILR 355 BS
Investigators
Eligibility Criteria
Inclusion Criteria
- •All participants in the study should be healthy males, ranging from 21 to 50 years of age and their body mass index (BMI) be within 18.5 to 29.9 kg/m2 (BMI calculation: weight in kilograms divided by the square of height in meters).
- •In accordance with Good clinical practice (GCP) and the local legislation all volunteers will have given their written informed consent 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 or during the study
- •Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
- •Participation in another trial with an investigational drug (≤ two months prior to administration or during the trial)
- •Smoker (\> 10 cigarettes or \> 3 cigars of \> 3 pipes/day)
Arms & Interventions
BILR 355 BS
escalating doses
Intervention: BILR 355 BS
BILR 355 BS
escalating doses
Intervention: PEG 400
Placebo
Intervention: PEG 400
Outcomes
Primary Outcomes
Number of participants with clinically significant changes in vital functions
Time Frame: Up to 10 days after drug administration
Number of participants with abnormal findings in skin inspections
Time Frame: Up to 10 days after drug administration
Number of participants with abnormal neurological finding
Time Frame: Up to 10 days after drug administration
Number of participants with abnormal findings in ECG (electrocardiogram)
Time Frame: Up to 10 days after drug administration
Number of participants with abnormal changes in laboratory parameters
Time Frame: Up to 10 days after drug administration
Number of participants with positive faecal occult blood testing
Time Frame: Up to 10 days after drug administration
Number of participants with adverse events
Time Frame: Up to 10 days after drug administration
Secondary Outcomes
- Time to attain maximum plasma concentration (tmax)(Up to 144 hours after drug administration)
- Terminal half life (t½)(Up to 144 hours after drug administration)
- Apparent clearance of the analyte in plasma following extravascular administration (CL/F)(Up to 144 hours after drug administration)
- Maximum plasma concentration (Cmax)(Up to 144 hours after drug administration)
- Area under the concentration-time curve of the analyte in plasma from zero time to infinity (AUC0-∞)(Up to 144 hours after drug administration)
- Apparent volume of distribution during the terminal elimination phase (Vz/F)(Up to 144 hours after drug administration)
- Amount of drug excreted in the urine (Ae)(Up to 72 hours after drug administration)
- Total mean residence time (MRTtot)(Up to 144 hours after drug administration)
- Area under the concentration-time curve of the analyte in plasma from zero time to the time of the last quantifiable drug concentration (AUC0-tz)(Up to 144 hours after drug administration)
- Renal clearance of the analyte (CLR)(Up to 72 hours after drug administration)
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