Metabolism and Pharmacokinetics of [14C]-DK-AH 269 CL in 12 Healthy Male Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: [14C]-DK-AH 269 CL, drinking solutionDrug: [14C]-DK-AH 269 CL, solution for infusion
- Registration Number
- NCT02264028
- Lead Sponsor
- Boehringer Ingelheim
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
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.
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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 exclusion criteria for the drugs under study or for the study:
- Subjects at increased risk for development of cardiac arrhythmia (e.g. family history of long QT syndrome or sudden cardiac death)
- ECG: PR interval > 210 ms
- HR at rest ≤ 55 beats per minute (bpm)
- Relevant ophthalmological disease
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description [14C]-DK-AH 269 CL oral [14C]-DK-AH 269 CL, drinking solution - [14C]-DK-AH 269 CL intravenous [14C]-DK-AH 269 CL, solution for infusion -
- Primary Outcome Measures
Name Time Method 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 Ratio of CBlood cells/Cplasma [14C]-radioactivity Up to 96 hours after start of treatment 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 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
- Secondary Outcome Measures
Name Time Method