Status:
COMPLETED
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
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
30-60 years
Phase:
PHASE1
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
- 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
- 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
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT02256735
Start Date
August 1 2005
Last Update
October 6 2014
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