Clinical trial NCT02256735: 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
Official title: A Double-blinded, Randomised, Placebo Controlled, Five-way Crossover Study With One Positive Control (Open-label) (Moxifloxacin) to Assess the Influence of Oral Single Dose KUC 7483 BS (40 mg, 80 mg, 160 mg, 320 mg) on the QT/QTc Interval of the ECG in Healthy Male and Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-06
Enrollment: 39
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in mean time-matched QTcI
timeFrame: up to 2 hours following drug administration
Secondary outcomes:
measure: Change from baseline in mean time-matched QTcI
timeFrame: up to 8 hours following drug administration
measure: Occurrence of uncorrected QT interval
timeFrame: up to 8 hours following drug administration
measure: Occurrence of the QTcI interval
timeFrame: up to 8 hours following drug administration
measure: Change from baseline of the QTcI interval
timeFrame: up to 8 hours following drug administration
measure: Change from baseline in Heart Rate (HR)
timeFrame: up to 6 hours following drug administration
measure: Cmax (maximum measured concentration of the analyte in plasma)
timeFrame: up to 8 hours following drug administration
measure: tmax (time from dosing to the maximum concentration of the analyte in plasma)
timeFrame: up to 8 hours following drug administration
measure: AUC0-6 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours)
timeFrame: up to 6 hours following drug administration
measure: AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 8 hours) for moxifloxacin
timeFrame: up to 8 hours following drug administration
measure: Number of subjects with adverse events
timeFrame: up to 17 days after last drug administration
measure: Number of subjects with abnormal changes in laboratory parameters
timeFrame: up to 17 days after last drug administration
measure: Number of subjects with abnormal changes in 12-lead ECG
timeFrame: up to 17 days after last drug administration
measure: Number of patients with clinically significant changes in vital signs
timeFrame: up to 17 days after last drug administration
measure: Assessment of tolerability by investigator on a 4-point scale
timeFrame: 17 days after last drug administration
Other outcomes:
Locations:
Study officials:
References: