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

NCT02256735 | Completed Phase 1

• 1 other identifier: 1207.22
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in mean time-matched QTcI

  up to 2 hours following drug administration

Secondary Outcomes (14)

• 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

• Occurrence of the QTcI interval

  up to 8 hours following drug administration

• Change from baseline of the QTcI interval

  up to 8 hours following drug administration

• Change from baseline in Heart Rate (HR)

  up to 6 hours following drug administration

Study Arms (6)

Treatment A

EXPERIMENTAL

Drug: Treatment A

Treatment B

EXPERIMENTAL

Drug: Treatment B

Treatment C

EXPERIMENTAL

Drug: Treatment C

Treatment D

EXPERIMENTAL

Drug: Treatment D

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Moxifloxacin

ACTIVE COMPARATOR

Drug: Moxifloxacin

Interventions

Treatment A DRUG

Ritobegron Cl (KUC 7483 CL) tablets low dose

Treatment A

Treatment B DRUG

Also known as: Ritobegron Cl (KUC 7483 CL) tablets medium 1 dose

Treatment B

Treatment C DRUG

Also known as: Ritobegron Cl (KUC 7483 CL) tablets medium 2 dose

Treatment C

Treatment D DRUG

Also known as: Ritobegron Cl (KUC 7483 CL) tablets high dose

Treatment D

Placebo DRUG

Placebo

Moxifloxacin DRUG

Moxifloxacin

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Culture Media; Moxifloxacin

Intervention Hierarchy (Ancestors)

Laboratory Chemicals; Specialty Uses of Chemicals; Chemical Actions and Uses; Equipment and Supplies; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 6, 2014
• Study Start: August 1, 2005
• Primary Completion: December 1, 2005
• Last Updated: October 6, 2014

Record last verified: 2014-10