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Completed

NCT Number: NCT02256722

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

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Key information

Conditions

Age range

30 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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
  • 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)

Treatment and study plan

KUC 7483 CL

Drug

Bisoprolol

Drug

Propranolol

Drug

Acipimox

Drug

Salmeterol

Drug

Primary outcomes

  1. Absolute change from baseline in glucose

    Time frame: up to 24 hours after administration of study drug

  2. Percentage change from baseline in glucose

    Time frame: up to 24 hours after administration of study drug

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

    Time frame: up to 24 hours after administration of study drug

  4. Percentage change from baseline in FFA

    Time frame: up to 24 hours after administration of study drug

  5. Absolute change from baseline in insulin

    Time frame: up to 24 hours after administration of study drug

  6. Percentage change from baseline in insulin

    Time frame: up to 24 hours after administration of study drug

  7. Absolute change from baseline in C-Peptide

    Time frame: up to 24 hours after administration of study drug

  8. Percentage change from baseline in C-Peptide

    Time frame: up to 24 hours after administration of study drug

  9. Absolute change from baseline in Potassium

    Time frame: up to 24 hours after administration of study drug

  10. Percentage change from baseline in Potassium

    Time frame: up to 24 hours after administration of study drug

  11. Absolute change from baseline in Magnesium

    Time frame: up to 24 hours after administration of study drug

  12. Percentage change from baseline in Magnesium

    Time frame: up to 24 hours after administration of study drug

  13. Absolute change from baseline in cAMP

    Time frame: up to 24 hours after administration of study drug

  14. Percentage change from baseline in cAMP

    Time frame: up to 24 hours after administration of study drug

Secondary outcomes

  1. Number of subjects with adverse events

    Time frame: up to 80 days

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

    Time frame: up to 24 hours after administration of study drug

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

    Time frame: up to 24 hours after administration of study drug

  4. Number of subjects with clinically relevant findings in electrocardiogram

    Time frame: up to 24 hours after administration of study drug

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

    Time frame: Baseline, within 10 days after last drug administration

  6. Maximum measured concentration of the analyte in plasma

    Time frame: up to 24 hours after administration of study drug

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

    Time frame: 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

    Time frame: up to 24 hours after administration of study drug

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2005
First posted
Oct 6, 2014
Registry last updated
Oct 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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