Healthy
Conditions
Brief summary
* To investigate absorption, metabolism and excretion of \[14C\]-DK-AH 269 CL after oral and intravenous administration in healthy volunteers * To assess the safety and tolerability of DK-AH 269 CL after oral and intravenous administration to healthy volunteers
Interventions
DRUG[14C]-DK-AH 269 CL, solution for infusion
DRUG[14C]-DK-AH 269 CL, drinking solution
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 50 to 65 years of age * Body Mass Index (BMI) of 19.9 to 29.9 kg/m2 * Resting heart rate (HR) (after 5 min. in the supine position) of more than 55 bpm * All volunteers will have given their written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.
Exclusion criteria
* Any finding at the medical examination (including BP, HR and ECG) deviating from normal and of clinical relevance * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, hematological/oncological, immunological or hormonal disorders * Diseases of the central nervous system or psychiatric disorders or neurological disorders * History of relevant orthostatic hypotension, fainting spells or blackouts * Chronic or 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 hours) within ten half-lives of the respective drug before enrolment in the study * Use of any drugs which might influence the results of the trial within two weeks prior to administration or during the trial * Participation in another trial with an investigational drug (≤ 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 2 months prior to administration or during the trial) * Excessive physical activities (within the last week before the study) * Any laboratory value outside the reference range and of clinical relevance * Inability to comply with dietary regimen of study centre Not necessarily clinically relevant abnormalities, but specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with clinically significant findings in vital signs | up to 12 days after last drug administration | blood pressure, heart rate |
| Number of patients with clinically significant findings in 12-lead ECG | up to 12 days after last drug administration | — |
| Ratio of CBlood cells/Cplasma [14C]-radioactivity | Up to 96 hours after start of treatment | — |
| Maximum measured concentration of the analytes in plasma (Cmax) | Up to 96 hours after start of treatment | — |
| Area under the concentration-time curve of the analytes in plasma (AUC) | Up to 96 hours after start of treatment | — |
| Time from dosing to the maximum concentration of the analytes in plasma (tmax) | Up to 96 hours after start of treatment | — |
| Terminal rate constant of the analytes in plasma (λz) | Up to 96 hours after start of treatment | — |
| Terminal half-life of the analytes in plasma (t1/2) | Up to 96 hours after start of treatment | — |
| Mean residence time of the analytes in the body after intravenous administration (MRT) | Up to 96 hours after start of treatment | — |
| Mean residence time of the analytes in the body after oral administration (MRTpo) | Up to 96 hours after start of treatment | — |
| Apparent clearance of the analytes in plasma following extravascular administration (CL/F) | Up to 96 hours after start of treatment | — |
| Total clearance of the analytes in plasma following intravascular administration (CL) | Up to 96 hours after start of treatment | — |
| Apparent volume of distribution of the analytes during the terminal phase λz following extravascular administration (Vz/F) | Up to 96 hours after start of treatment | — |
| Volume of distribution at steady state (Vss) | Up to 96 hours after start of treatment | — |
| Fraction of analytes eliminated in urine from 0 to the time of the last quantifiable data point (fe0-tz) | Up to 120 hours after start of treatment | — |
| Fraction of analytes eliminated in faeces from 0 to the time of the last quantifiable data point (fefaeces,0-tz) | Up to 120 hours after start of treatment | — |
| Renal clearance of the analytes from 0 to the time of the last quantifiable data point (CLR,0-tz) | Up to 120 hours after start of treatment | — |
| Fraction of dose absorbed, based on radioactivity data (Fa) | Up to 96 hours after start of treatment | — |
| Absolute bioavailability of the analytes after oral administration (F) | Up to 96 hours after start of treatment | — |
| Number of patients with clinically significant findings in 2-lead ECG (telemetry) | up to 90 minutes after start of treatment | — |
| Clinically significant changes from baseline in physical examination | Pre-dose, and 12 days after last drug administration | — |
| Occurrence of visual phenomena | up to 120 hours after start of treatment | questionnaire |
| Number of patients with clinically significant findings in clinical laboratory tests | up to 12 days after last drug administration | — |
Outcome results
None listed