Single Rising Dose Study of BI 201335 ZW in Healthy Male Subjects
Phase 1
Terminated
- Conditions
- Healthy
- Interventions
- Drug: PlaceboDrug: BI 201335 ZW - single rising dose
- Registration Number
- NCT02182271
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objective of the current study is to investigate safety, tolerability, and pharmacokinetics of BI 201335 ZW following administration of single rising doses from 5 mg to 1500 mg. In addition Two stage intra-subject bioavailability comparison of 600 mg BI 201335 ZW as a liquid formulation given with and without food.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 8
Inclusion Criteria
- Healthy males according to the following criteria based upon a complete medical history, including the physical examination, vital signs ((blood pressure (BP), pulse rate (HR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
- Age ≥18 and Age ≤55 years
- BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
- Willingness to abstain from alcohol from screening period until conclusion visit
Exclusion Criteria
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders, including a clinical history of viral hepatitis, or serological evidence of active Hepatitis B or Hepatitis C infection
- History of orthostatic hypotension, fainting spells and blackouts
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- 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 1 month prior to administration
- Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
- Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on trial days
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Blood donation within 1 month prior to administration or during the trial
- Excessive physical activities within 5 days prior to administration or during the trial
- Any laboratory value outside the clinically accepted reference range and of clinical relevance
- History of any familial bleeding disorder
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - BI 201335 ZW - single rising dose BI 201335 ZW - single rising dose -
- Primary Outcome Measures
Name Time Method Number of patients with abnormal findings in physical examination Baseline, day 3 of each treatment period, within 8 days after last administration Number of patients with clinically significant changes in 12-lead ECG (electrocardiogram) Baseline, day 1, 2 in treatment period, within 8 days after last administration Number of patients with abnormal changes in laboratory parameters Baseline, day 1-3 of each treatment period, within 8 days after last administration Number of patients with clinically significant changes in vital signs Baseline, day 1-3 of each treatment period, within 8 days after last administration Number of patients with adverse events up to 13 days Assessment of tolerability by investigator on a 4-point scale on day 3 of each treatment period
- Secondary Outcome Measures
Name Time Method Cmax (maximum concentration of the analyte in plasma) pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 15, 24, 30, 36 and 48 hours post-dose tmax (time from dosing to maximum concentration) pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 15, 24, 30, 36 and 48 hours post-dose t1/2 (terminal half-life of the analyte in plasma) pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 15, 24, 30, 36 and 48 hours post-dose AUC0-∞ (area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 15, 24, 30, 36 and 48 hours post-dose AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 15, 24, 30, 36 and 48 hours post-dose λz (terminal elimination rate constant in plasma) pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 15, 24, 30, 36 and 48 hours post-dose CL/F (apparent clearance of the analyte in the plasma after oral administration) pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 15, 24, 30, 36 and 48 hours post-dose Vz/F (apparent volume of distribution during the terminal phase λz following an oral dose) pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 15, 24, 30, 36 and 48 hours post-dose MRTpo (Mean residence time of the analyte in the body after oral administration) pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 15, 24, 30, 36 and 48 hours post-dose