Safety, Tolerability and Pharmacokinetics of Single Risin... | NCT02259972

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BI 113823 solution	Experimental	single rising doses, dose group 5 twice (fed and fasted)	Drug: BI 113823 solution Other: High fat, high calorie breakfast
BI 113823 tablet	Experimental	dose group 5 only	Drug: BI 113823 tablet Other: High fat, high calorie breakfast
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
BI 113823 solution	Drug		BI 113823 solution
BI 113823 tablet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with clinically significant findings on physical examination		up to 14 days after last drug administration
Number of participants with clinically significant findings in vital signs	blood pressure (BP), pulse rate (PR)	up to 14 days after last drug administration
Number of participants with clinically significant findings in 12-lead electrocardiogram (ECG)	special attention to QRS prolongation	up to 14 days after last drug administration
Number of participants with clinically significant findings in laboratory tests		up to 14 days after last drug administration
Number of participants with adverse events		up to 14 days after last drug administration
Assessment of tolerability by investigator on a 4-point scale		up to 14 days after last drug administration

Secondary Outcomes

Measure	Description	Time Frame
Cmax (maximum measured concentration of the analyte in plasma)		up to 72 hours after drug administration
tmax (time from dosing to maximum measured concentration)		up to 72 hours after 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
Age ≥18 and Age ≤45 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 GCP and the local legislation

Exclusion Criteria:

Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
History of relevant orthostatic hypotension, fainting spells or blackouts
Chronic or relevant acute infections
History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration
Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration
Participation in another trial with an investigational drug within 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 (more than 30 g/day)
Drug abuse
Blood donation (more than 100 mL within four weeks prior to administration)
Excessive physical activities (within one week prior to administration)
Any laboratory value outside the reference range that is of clinical relevance
Inability to comply with dietary regimen of trial site
Bradycardia < 50/min, PR interval > 200 ms, QRS interval > 110 ms, QTcB > 450 ms, or QT (uncorrected) > 470 ms or any other relevant ECG findings at screening
A history of additional risk factors for Torsades des Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)