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HealthyPhase 1NCT02256735

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

A Phase 1 study testing Treatment A, Treatment B and Treatment C in people with Healthy, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 30 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Treatment A, Treatment B and Treatment C
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
39 participants
Where
No sites listed yet
Study dates
Aug 2005to Dec 2005
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 26Show fewer
  • 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

About this study

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 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
Being tested
Treatment A, Treatment B, Treatment C, Treatment D, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treatment ADrug

    Ritobegron Cl (KUC 7483 CL) tablets low dose

  • Treatment BDrug

    Also called Ritobegron Cl (KUC 7483 CL) tablets medium 1 dose

  • Treatment CDrug

    Also called Ritobegron Cl (KUC 7483 CL) tablets medium 2 dose

  • Treatment DDrug

    Also called Ritobegron Cl (KUC 7483 CL) tablets high dose

  • PlaceboDrug

  • MoxifloxacinDrug

Study groups in NCT02256735
Study groupRoleWhat they receive
Treatment AExperimentalNot described
Receives: Drug: Treatment A
Treatment BExperimentalNot described
Receives: Drug: Treatment B
Treatment CExperimentalNot described
Receives: Drug: Treatment C
Treatment DExperimentalNot described
Receives: Drug: Treatment D
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
MoxifloxacinActive comparatorNot described
Receives: Drug: Moxifloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in mean time-matched QTcI

    Measured: up to 2 hours following drug administration

Secondary outcomes (14)

  1. Change from baseline in mean time-matched QTcI

    Measured: up to 8 hours following drug administration

  2. Occurrence of uncorrected QT interval

    QT interval <=500 ms, > 500 ms

    Measured: up to 8 hours following drug administration

  3. Occurrence of the QTcI interval

    QTcI interval <= 450 ms, >450 ms, >480 ms or >500 ms

    Measured: up to 8 hours following drug administration

  4. Change from baseline of the QTcI interval

    QTcI interval < 30 ms, ≤ 60 ms

    Measured: up to 8 hours following drug administration

  5. Change from baseline in Heart Rate (HR)

    increase ≥25 % or decrease HR by ≥25 %

    Measured: up to 6 hours following drug administration

  6. Cmax (maximum measured concentration of the analyte in plasma)

    Measured: up to 8 hours following drug administration

  7. tmax (time from dosing to the maximum concentration of the analyte in plasma)

    Measured: up to 8 hours following drug administration

  8. AUC0-6 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours)

    Measured: up to 6 hours following drug administration

  9. AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 8 hours) for moxifloxacin

    Measured: up to 8 hours following drug administration

  10. Number of subjects with adverse events

    Measured: up to 17 days after last drug administration

  11. Number of subjects with abnormal changes in laboratory parameters

    Measured: up to 17 days after last drug administration

  12. Number of subjects with abnormal changes in 12-lead ECG

    Measured: up to 17 days after last drug administration

  13. Number of patients with clinically significant changes in vital signs

    Blood pressure, pulse rate

    Measured: up to 17 days after last drug administration

  14. Assessment of tolerability by investigator on a 4-point scale

    Measured: 17 days after last drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2014 (estimated)
  2. Study startAug 2005
  3. Primary completionDec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02256735
Sponsor's protocol ID
1207.22
Status last verified
Oct 2014
First submitted
2 Oct 2014
Last updated
6 Oct 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Treatment A, Treatment B and Treatment C in people with Healthy, run by Boehringer Ingelheim.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in mean time-matched QTcI (time frame: up to 2 hours following drug administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02256735.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2014.

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