Safety, Tolerability and Pharmacokinetics of Single Risin... | NCT02259764

NCT02259764

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
KUC 7483 CL - single rising dose	Experimental	Treatment 1: KUC 7483 CL - low dose Treatment 2: KUC 7483 CL - medium dose Treatment 3: KUC 7483 CL - high dose In treatment 3 the same subjects as in treatment 2 received drug immediately after the ingestion of a standardized high fat meal	Drug: KUC 7483 CL - single rising dose Other: standardized high fat meal
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
KUC 7483 CL - single rising dose	Drug		KUC 7483 CL - single rising dose
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of subjects with abnormal findings in physical examination		up to 8 days after last drug administration
Number of subjects with abnormal changes in laboratory parameters	special parameters, Tropanin I, insulin, C-Peptide, glucagon, free fatty acids, lactate, potassium, cAMP and faecal occult blood testing	up to 8 days after last drug administration
Number of subjects with clinically significant changes in vital signs	Blood Pressure, Pulse Rate, Respiratory Rate, body temperature, orthostatic testing	up to 8 days after last drug administration
Number of subjects with clinically significant changes in 12-lead ECG (electrocardiogram)		up to 8 days after last drug administration
Number of subjects with adverse events		up to 8 days after last drug administration
Assessment of tolerability by investigator on a 4-point scale		8 days after last drug administration

Secondary Outcomes

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

1.1 No finding deviating from normal and of clinical relevance

1.2 No evidence of a clinically relevant concomitant disease
Age ≥ 30 and Age ≤ 60 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:

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 relevant 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 10 half-lives of the respective drug prior to administration or during the trial
Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
Participation in another trial with an investigational drug within two months prior to administration or during the trial
Smoker (> 10 cigarettes or > 3 cigars of > 3 pipes/day)
Inability to refrain from smoking on trial days
Alcohol abuse (more than 60 g/day)
Drug abuse
Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
Excessive physical activities (within one week prior to administration or during the trial)
Any laboratory value outside the reference range of clinical relevance

The clinical relevance of study parameters will be assessed by the investigator or his deputy