Clinical trial NCT02256722: In Vivo Specificity of KUC 7483 CL Co-administered With Bisoprolol, Propranolol, and Acipimox in Healthy Male Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-06
Enrollment: 12
Sex: MALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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. 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


Eligibility criteria: 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)

Primary outcomes:
measure: Absolute change from baseline in glucose
timeFrame: up to 24 hours after administration of study drug
measure: Percentage change from baseline in glucose
timeFrame: up to 24 hours after administration of study drug
measure: Absolute change from baseline in free fatty acids (FFA)
timeFrame: up to 24 hours after administration of study drug
measure: Percentage change from baseline in FFA
timeFrame: up to 24 hours after administration of study drug
measure: Absolute change from baseline in insulin
timeFrame: up to 24 hours after administration of study drug
measure: Percentage change from baseline in insulin
timeFrame: up to 24 hours after administration of study drug
measure: Absolute change from baseline in C-Peptide
timeFrame: up to 24 hours after administration of study drug
measure: Percentage change from baseline in C-Peptide
timeFrame: up to 24 hours after administration of study drug
measure: Absolute change from baseline in Potassium
timeFrame: up to 24 hours after administration of study drug
measure: Percentage change from baseline in Potassium
timeFrame: up to 24 hours after administration of study drug
measure: Absolute change from baseline in Magnesium
timeFrame: up to 24 hours after administration of study drug
measure: Percentage change from baseline in Magnesium
timeFrame: up to 24 hours after administration of study drug
measure: Absolute change from baseline in cAMP
timeFrame: up to 24 hours after administration of study drug
measure: Percentage change from baseline in cAMP
timeFrame: up to 24 hours after administration of study drug
Secondary outcomes:
measure: Number of subjects with adverse events
timeFrame: up to 80 days
measure: Number of subjects with clinically relevant changes in laboratory tests
timeFrame: up to 24 hours after administration of study drug
measure: Number of subjects with clinically relevant changes in vital signs
timeFrame: up to 24 hours after administration of study drug
measure: Number of subjects with clinically relevant findings in electrocardiogram
timeFrame: up to 24 hours after administration of study drug
measure: Number of subjects with clinically relevant changes in physical examination
timeFrame: Baseline, within 10 days after last drug administration
measure: Maximum measured concentration of the analyte in plasma
timeFrame: up to 24 hours after administration of study drug
measure: Time from dosing to the maximum concentration of the analyte in plasma
timeFrame: up to 24 hours after administration of study drug
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 4 hours
timeFrame: up to 24 hours after administration of study drug
Other outcomes:
Locations:
Study officials:
References: