Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of KUC 7483 CL Tablets in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: KUC 7483 CL - single rising dose; Drug: Placebo; Other: standardized high fat meal

• Registration Number: NCT02259764
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Study to investigate safety, tolerability and pharmacokinetics of KUC 7483 CL

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Primary Completion: 2004-09
• Status Verified: 2014-10
• Study First Submitted: 2014-10-06
• Study First Submitted QC: 2014-10-06
• Last Update Submitted: 2014-10-06
• Study First Posted: 2014-10-09
• Last Update Posted: 2014-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

1. 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

2. Age ≥ 30 and Age ≤ 60 years

3. BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)

4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KUC 7483 CL - single rising dose	KUC 7483 CL - single rising dose	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
Placebo	Placebo	-
KUC 7483 CL - single rising dose	standardized high fat meal	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
tmax (time from dosing to the maximum concentration of the analyte in plasma)	up to 48 hours after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)	up to 48 hours after drug administration
Cmax (maximum measured concentration of the analyte in plasma)	up to 48 hours after drug administration
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)	up to 48 hours after drug administration
MRTpo (mean residence time of the analyte in the body after oral administration)	up to 48 hours after drug administration
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)	up to 48 hours after drug administration
λ z (terminal rate constant of the analyte in plasma)	up to 48 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)	up to 48 hours after drug administration
Aet1-t2 (amount of the analyte that is eliminated in urine from the time point t1 until time point t2)	up to 48 hours after drug administration
fet1-t2 (fraction of administered drug excreted unchanged in urine from the time point t1 until time point t2)	up to 48 hours after drug administration
CLR,t1-t2 (renal clearance of the analyte determined from the time point t1 until time point t2)	up to 48 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)	up to 48 hours after drug administration