AzTrials
AzTrials

HealthyPhase 1NCT02256722

In Vivo Specificity of KUC 7483 CL Co-administered With Bisoprolol, Propranolol, and Acipimox in Healthy Male Subjects

A Phase 1 study testing KUC 7483 CL, Bisoprolol and Propranolol 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
Search all trials

Trial summary

Study to compare the metabolic and electrolyte effects of a single oral dose of 320 mg ritobegron administered alone or with a pre- and comedication with bisoprolol, propranolol and acipimox. Read more about this study

Who is it for?
Ages 30 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
KUC 7483 CL, Bisoprolol and Propranolol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
No sites listed yet
Study dates
Oct 2005to Nov 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
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male
  • Age >= 30 and <= 60 years
  • Body Mass Index (BMI) >= 18.5 and <= 29.9 kg/m2
  • Signed and dated written informed consent in accordance with Good Clinical Practice and local legislation

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 23Show 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
  • Alcohol abuse (> 60 g/day)
  • 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, salmeterol and/or related drugs of these classes
  • Congenital or documented acquired QT- prolongation, previous history of symptomatic arrhythmias
  • Systolic BP < 115 mmHg
  • Heart rate at rest of > 80 bpm or < 55 bpm
  • Any screening ECG value outside of the reference range of clinical relevance including, but not limited to PR interval > 220 ms, QRS interval > 115 ms, QTcB > 420 ms, or QT (uncorrected) > 450 ms
  • History of asthma or obstructive pulmonary disease.
  • Psoriasis (own medical history or relative)

About this study

Official title: A Randomised, Open Label, Four-way Crossover Phase I Trial to Investigate the in Vivo Specificity of a Single Oral Dose of 320 mg KUC 7483 CL Co-administered With Bisoprolol (10 mg Daily), Propranolol (160 mg Daily), and Acipimox (500 mg Daily) Over 5 Days and a Single Inhalative Dose of 100 μg Salmeterol in Healthy Male Subjects

Study to compare the metabolic and electrolyte effects of a single oral dose of 320 mg ritobegron administered alone or with a pre- and comedication with bisoprolol, propranolol and acipimox. In addition, to compare the metabolic and electrolyte effects of a single dose of 320 mg ritobegron with those of a single inhalatory dose of 100 μg salmeterol

Conditions
Healthy
Being tested
KUC 7483 CL, Bisoprolol, Propranolol, Acipimox, Salmeterol

What participants receive

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

  • KUC 7483 CLDrug

  • BisoprololDrug

  • PropranololDrug

  • AcipimoxDrug

  • SalmeterolDrug

Study groups in NCT02256722
Study groupRoleWhat they receive
Treatment AExperimentalNot described
Receives: Drug: KUC 7483 CL
Treatment BExperimentalNot described
Receives: Drug: KUC 7483 CL; Drug: Bisoprolol
Treatment CExperimentalNot described
Receives: Drug: KUC 7483 CL; Drug: Propranolol
Treatment DExperimentalNot described
Receives: Drug: KUC 7483 CL; Drug: Acipimox
Treatment EActive comparatorNot described
Receives: Drug: Salmeterol

What is being measured

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

  1. Absolute change from baseline in glucose

    Measured: up to 24 hours after administration of study drug

  2. Percentage change from baseline in glucose

    Measured: up to 24 hours after administration of study drug

  3. Absolute change from baseline in free fatty acids (FFA)

    Measured: up to 24 hours after administration of study drug

  4. Percentage change from baseline in FFA

    Measured: up to 24 hours after administration of study drug

  5. Absolute change from baseline in insulin

    Measured: up to 24 hours after administration of study drug

  6. Percentage change from baseline in insulin

    Measured: up to 24 hours after administration of study drug

  7. Absolute change from baseline in C-Peptide

    Measured: up to 24 hours after administration of study drug

  8. Percentage change from baseline in C-Peptide

    Measured: up to 24 hours after administration of study drug

  9. Absolute change from baseline in Potassium

    Measured: up to 24 hours after administration of study drug

  10. Percentage change from baseline in Potassium

    Measured: up to 24 hours after administration of study drug

  11. Absolute change from baseline in Magnesium

    Measured: up to 24 hours after administration of study drug

  12. Percentage change from baseline in Magnesium

    Measured: up to 24 hours after administration of study drug

  13. Absolute change from baseline in cAMP

    Measured: up to 24 hours after administration of study drug

  14. Percentage change from baseline in cAMP

    Measured: up to 24 hours after administration of study drug

Secondary outcomes (8)

  1. Number of subjects with adverse events

    Measured: up to 80 days

  2. Number of subjects with clinically relevant changes in laboratory tests

    Measured: up to 24 hours after administration of study drug

  3. Number of subjects with clinically relevant changes in vital signs

    Measured: up to 24 hours after administration of study drug

  4. Number of subjects with clinically relevant findings in electrocardiogram

    Measured: up to 24 hours after administration of study drug

  5. Number of subjects with clinically relevant changes in physical examination

    Measured: Baseline, within 10 days after last drug administration

  6. Maximum measured concentration of the analyte in plasma

    Measured: up to 24 hours after administration of study drug

  7. Time from dosing to the maximum concentration of the analyte in plasma

    Measured: up to 24 hours after administration of study drug

  8. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 4 hours

    Measured: up to 24 hours after administration of study drug

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 startOct 2005
  3. Primary completionNov 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
Crossover
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02256722
Sponsor's protocol ID
1207.26
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 KUC 7483 CL, Bisoprolol and Propranolol 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 23 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. 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?

Absolute change from baseline in glucose (time frame: up to 24 hours after administration of study drug). The study lists 14 primary outcomes in all. 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 NCT02256722.

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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in