Safety, Tolerance, and Pharmacokinetics of Single Rising... | NCT02256787

NCT02256787

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BILB 1941 ZW - single rising dose	Experimental	Single rising dose part	Drug: BILB 1941 ZW - single rising dose part
Placebo	Placebo Comparator	Single rising dose part	Drug: Placebo
BILB 1941 ZW - tablet - fasted	Experimental	Relative bioavailability: The oral solution fasted should be compared with the solid form fasted and after a standardized breakfast	Drug: BILB 1941 ZW - tablet
BILB 1941 ZW - solution	Experimental	Relative bioavailability: The oral solution fasted should be compared with the solid form fasted and after a standardized breakfast	Drug: BILB 1941 ZW - solution
BILB 1941 ZW - tablet - fed	Experimental	Relative bioavailability: The oral solution fasted should be compared with the solid form fasted and after a standardized breakfast	Drug: BILB 1941 ZW - tablet Other: standardized breakfast

Name	Type	Description	Arm Group Labels	Other Names
BILB 1941 ZW - single rising dose part	Drug		BILB 1941 ZW - single rising dose
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of subjects with abnormal findings in physical examination		up to 48 hours following drug administration
Number of subjects with abnormal changes in laboratory parameters		up to 48 hours following drug administration
Number of subjects with clinically significant changes in vital signs	Blood pressure, Pulse Rate	up to 48 hours following drug administration
Number of subjects with adverse events		up to 48 hours following drug administration
Number of subjects with clinically significant changes in 12-lead ECG (electrocardiogram)		up to 48 hours following drug administration
Assessment of tolerability by investigator on a 4-point scale		after 48 hours following drug administration

Secondary Outcomes

Measure	Description	Time Frame
Cmax (maximum concentration of the analyte in plasma)		up to 48 hours following drug administration
tmax (time from dosing to maximum concentration)		up to 48 hours following drug administration

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy males according to the following criteria based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests:

1.1 No finding deviating from normal and of clinical relevance

1.2 No evidence of a clinically relevant concomitant disease
Age ≥18 and Age ≤50 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

Exclusion Criteria:

Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
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 1 month 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 of more than 100 mL 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