Healthy
Conditions
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
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 60 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change from baseline in cAMP | up to 24 hours after administration of study drug |
| Absolute change from baseline in C-Peptide | up to 24 hours after administration of study drug |
| Percentage change from baseline in C-Peptide | up to 24 hours after administration of study drug |
| Absolute change from baseline in glucose | up to 24 hours after administration of study drug |
| Absolute change from baseline in Potassium | up to 24 hours after administration of study drug |
| Percentage change from baseline in Potassium | up to 24 hours after administration of study drug |
| Absolute change from baseline in Magnesium | up to 24 hours after administration of study drug |
| Percentage change from baseline in Magnesium | up to 24 hours after administration of study drug |
| Absolute change from baseline in cAMP | up to 24 hours after administration of study drug |
| Percentage change from baseline in glucose | up to 24 hours after administration of study drug |
| Absolute change from baseline in free fatty acids (FFA) | up to 24 hours after administration of study drug |
| Percentage change from baseline in FFA | up to 24 hours after administration of study drug |
| Absolute change from baseline in insulin | up to 24 hours after administration of study drug |
| Percentage change from baseline in insulin | up to 24 hours after administration of study drug |
Secondary
| Measure | Time frame |
|---|---|
| Number of subjects with clinically relevant changes in laboratory tests | up to 24 hours after administration of study drug |
| Number of subjects with clinically relevant changes in vital signs | up to 24 hours after administration of study drug |
| Number of subjects with clinically relevant findings in electrocardiogram | up to 24 hours after administration of study drug |
| Number of subjects with clinically relevant changes in physical examination | Baseline, within 10 days after last drug administration |
| Maximum measured concentration of the analyte in plasma | up to 24 hours after administration of study drug |
| Time from dosing to the maximum concentration of the analyte in plasma | 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 | up to 24 hours after administration of study drug |
| Number of subjects with adverse events | up to 80 days |
Outcome results
None listed