Study to Investigate the Effect of KUC 7483 CL on the QT/QTc Interval of the ECG in Comparison to Placebo and Moxifloxacin in Healthy Male and Female Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT02256735
- Lead Sponsor
- Boehringer Ingelheim
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment B Treatment B - Treatment C Treatment C - Placebo Placebo - Treatment A Treatment A - Treatment D Treatment D - Moxifloxacin Moxifloxacin -
- Primary Outcome Measures
Name Time Method Change from baseline in mean time-matched QTcI up to 2 hours following drug administration
- Secondary Outcome Measures
Name Time Method 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 Change from baseline in mean time-matched QTcI up to 8 hours following drug administration 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 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 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