Healthy
Conditions
Brief summary
Study to investigate the effect of Ritobegron CL (KUC 7483 CL) on the QT/QTc interval of the ECG in comparison to placebo and moxifloxacin
Interventions
DRUGTreatment A
Ritobegron Cl (KUC 7483 CL) tablets low dose
DRUGTreatment B
DRUGTreatment C
DRUGTreatment D
DRUGPlacebo
DRUGMoxifloxacin
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males or females * Age 30 to 60 years * Body mass index (BMI) within 18.5 to 29.9 kg/m2 * In accordance with Good Clinical Practice (GCP) and the local legislation all volunteers are to have given their written informed consent prior to admission to the study
Exclusion criteria
* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, clinically relevant electrolyte disturbances * Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders * History of orthostatic hypotension, fainting spells or blackouts * Chronic or clinically 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 (\> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study * Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study * 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 * Drug abuse * Blood donation (\> 100 mL within four weeks prior to administration or during the trial) * Any laboratory value outside the reference range if indicative of underlying disease or poor health * Excessive physical activities within the last week before the trial or during the trial * Hypersensitivity to treatment medication, moxifloxacin and/or related drugs of these classes * Previous tendon disease related to quinolone treatment * Congenital or documented acquired QT- prolongation, previous history of symptomatic arrhythmias * Heart rate at screening of \> 80 bpm or \< 45 bpm * Any screening ECG value outside of the reference range of clinical relevance including, but not limited to Pulse rate (PR) interval \> 220 ms, QRS interval \> 115 ms, QTcB \> 450 ms, or QT (uncorrected) \> 470 ms For Female Subjects: * Pregnancy * Positive pregnancy test * No adequate contraception (adequate contraception e.g. sterilization, Intrauterine pessary (IUP), oral contraceptives) * Inability to maintain this adequate contraception during the whole study period * Lactation period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in mean time-matched QTcI | up to 2 hours following drug administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of uncorrected QT interval | up to 8 hours following drug administration | QT interval \<=500 ms, \> 500 ms |
| Occurrence of the QTcI interval | up to 8 hours following drug administration | QTcI interval \<= 450 ms, \>450 ms, \>480 ms or \>500 ms |
| Change from baseline of the QTcI interval | up to 8 hours following drug administration | QTcI interval \< 30 ms, ≤ 60 ms |
| Change from baseline in Heart Rate (HR) | up to 6 hours following drug administration | increase ≥25 % or decrease HR by ≥25 % |
| Cmax (maximum measured concentration of the analyte in plasma) | up to 8 hours following drug administration | — |
| tmax (time from dosing to the maximum concentration of the analyte in plasma) | up to 8 hours following drug administration | — |
| Change from baseline in mean time-matched QTcI | up to 8 hours following drug administration | — |
| AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 8 hours) for moxifloxacin | up to 8 hours following drug administration | — |
| Number of subjects with adverse events | up to 17 days after last drug administration | — |
| Number of subjects with abnormal changes in laboratory parameters | up to 17 days after last drug administration | — |
| Number of subjects with abnormal changes in 12-lead ECG | up to 17 days after last drug administration | — |
| Number of patients with clinically significant changes in vital signs | up to 17 days after last drug administration | Blood pressure, pulse rate |
| Assessment of tolerability by investigator on a 4-point scale | 17 days after last drug administration | — |
| AUC0-6 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours) | up to 6 hours following drug administration | — |
Outcome results
None listed