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

NCT ID: NCT02256735

Last Updated: 2014-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment A

Group Type: EXPERIMENTAL

Treatment A

Intervention Type: DRUG

Ritobegron Cl (KUC 7483 CL) tablets low dose

Treatment B

Group Type: EXPERIMENTAL

Treatment B

Intervention Type: DRUG

Treatment C

Group Type: EXPERIMENTAL

Treatment C

Intervention Type: DRUG

Treatment D

Group Type: EXPERIMENTAL

Treatment D

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Moxifloxacin

Group Type: ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type: DRUG

Interventions

Treatment A

Ritobegron Cl (KUC 7483 CL) tablets low dose

Intervention Type: DRUG

Treatment B

Intervention Type: DRUG

Treatment C

Intervention Type: DRUG

Treatment D

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Moxifloxacin

Intervention Type: DRUG

Other Intervention Names

Ritobegron Cl (KUC 7483 CL) tablets medium 1 dose; Ritobegron Cl (KUC 7483 CL) tablets medium 2 dose; Ritobegron Cl (KUC 7483 CL) tablets high dose

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1207.22

Identifier Type: -

Identifier Source: org_study_id