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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Notify MeKey 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
Bisoprolol
DrugPropranolol
DrugAcipimox
DrugSalmeterol
DrugPrimary outcomes
-
Absolute change from baseline in glucose
Time frame: up to 24 hours after administration of study drug
-
Percentage change from baseline in glucose
Time frame: up to 24 hours after administration of study drug
-
Absolute change from baseline in free fatty acids (FFA)
Time frame: up to 24 hours after administration of study drug
-
Percentage change from baseline in FFA
Time frame: up to 24 hours after administration of study drug
-
Absolute change from baseline in insulin
Time frame: up to 24 hours after administration of study drug
-
Percentage change from baseline in insulin
Time frame: up to 24 hours after administration of study drug
-
Absolute change from baseline in C-Peptide
Time frame: up to 24 hours after administration of study drug
-
Percentage change from baseline in C-Peptide
Time frame: up to 24 hours after administration of study drug
-
Absolute change from baseline in Potassium
Time frame: up to 24 hours after administration of study drug
-
Percentage change from baseline in Potassium
Time frame: up to 24 hours after administration of study drug
-
Absolute change from baseline in Magnesium
Time frame: up to 24 hours after administration of study drug
-
Percentage change from baseline in Magnesium
Time frame: up to 24 hours after administration of study drug
-
Absolute change from baseline in cAMP
Time frame: up to 24 hours after administration of study drug
-
Percentage change from baseline in cAMP
Time frame: up to 24 hours after administration of study drug
Secondary outcomes
-
Number of subjects with adverse events
Time frame: up to 80 days
-
Number of subjects with clinically relevant changes in laboratory tests
Time frame: up to 24 hours after administration of study drug
-
Number of subjects with clinically relevant changes in vital signs
Time frame: up to 24 hours after administration of study drug
-
Number of subjects with clinically relevant findings in electrocardiogram
Time frame: up to 24 hours after administration of study drug
-
Number of subjects with clinically relevant changes in physical examination
Time frame: Baseline, within 10 days after last drug administration
-
Maximum measured concentration of the analyte in plasma
Time frame: up to 24 hours after administration of study drug
-
Time from dosing to the maximum concentration of the analyte in plasma
Time frame: up to 24 hours after administration of study drug
-
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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