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

Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses (400, 440 and 480 mg) of KUC 7483 CL Tablets in Healthy Male Volunteers. A Double-blind at Each Dose Level, Randomised, Placebo Controlled Study

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: KUC 7483 CL - single rising dose; Other: standardized high fat meal

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: 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	Drug: KUC 7483 CL - single rising dose; Other: standardized high fat meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with adverse events		up to 8 days after last drug administration
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
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
Assessment of tolerability by investigator on a 4-point scale		8 days after last drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
tmax (time from dosing to the maximum concentration 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
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)	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
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
Cmax (maximum measured concentration of the analyte in plasma)	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
MRTpo (mean residence time of the analyte in the body after oral administration)	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
λ z (terminal rate constant of the analyte in plasma)	up to 48 hours after drug administration

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: August 1, 2004
• Primary Completion (Actual): September 1, 2004

Study Registration Dates

• First Submitted: October 6, 2014
• First Submitted That Met QC Criteria: October 6, 2014
• First Posted (Estimate): October 9, 2014

Study Record Updates

• Last Update Posted (Estimate): October 9, 2014
• Last Update Submitted That Met QC Criteria: October 6, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 1207.6