- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02259907
Safety, Tolerability and Pharmacokinetics of KUC 7483 Tablets in Healthy Male Volunteers
October 7, 2014 updated by: Boehringer Ingelheim
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses (40 to 400 mg) of KUC-7483 Tablets in Healthy Male Volunteers (Double-blind at Each Dose Level, Randomised, Placebo Controlled Study) as Well as Food Effects at 80 mg (Intraindividual Testing in the Same Volunteers)
Study to investigate safety, tolerability and pharmacokinetics of KUC 7483
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
- No finding deviating from normal and of clinical relevance
- 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 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
|
Experimental: KUC 7483 CL
single rising doses
|
|
Experimental: KUC 7483 CL, fed
dosing after high fat meal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of subjects with adverse events
Time Frame: up to 8 days after last drug administration
|
up to 8 days after last drug administration
|
|
Number of subjects with clinically significant findings in physical examination
Time Frame: up to 8 days after last drug administration
|
up to 8 days after last drug administration
|
|
Number of subjects with clinically significant changes in vital signs
Time Frame: up to 8 days after last drug administration
|
Blood pressure, Pulse Rate, Respiratory Rate, body temperature, orthostatic testing
|
up to 8 days after last drug administration
|
Number of subjects with clinically significant findings in 12-lead ECG (electrocardiogram)
Time Frame: up to 8 days after last drug administration
|
up to 8 days after last drug administration
|
|
Number of subjects with clinically significant changes in laboratory parameters
Time Frame: up to 8 days after last drug administration
|
up to 8 days after last drug administration
|
|
Assessment of tolerability by investigator on a 3-point rating scale
Time Frame: within 8 days after last drug administration
|
within 8 days after last drug administration
|
|
Number of subjects with clinically significant changes in special laboratory parameters
Time Frame: up to 24 hours after drug administration
|
Tropanin I, Insulin, C-Peptide, Glucagon, free fatty acids and faecal occult blood testing
|
up to 24 hours after drug administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time Frame: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
t1/2 (terminal half-life of the analyte in plasma)
Time Frame: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time Frame: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time Frame: up to 48 hours after drug administration
|
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)
Time Frame: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
Cmax (maximum measured concentration of the analyte in plasma)
Time Frame: up to 48 hours after drug 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)
Time Frame: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
λz (terminal rate constant of the analyte constant in plasma)
Time Frame: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
MRTpo (mean residence time of the analyte in the body after oral administration)
Time Frame: up to 48 hours after drug 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)
Time Frame: up to 48 hours after drug administration
|
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)
Time Frame: up to 48 hours after drug administration
|
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)
Time Frame: up to 48 hours after drug administration
|
up to 48 hours after drug administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2003
Primary Completion (Actual)
February 1, 2004
Study Registration Dates
First Submitted
October 7, 2014
First Submitted That Met QC Criteria
October 7, 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 7, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 1207.1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States