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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; p-Hydroxyamphetamine; Ritobegron

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