Clinical trial NCT02264028: Metabolism and Pharmacokinetics of [14C]-DK-AH 269 CL in 12 Healthy Male Volunteers
Official title: Metabolism and Pharmacokinetics of [14C]-DK-AH 269 CL After Administration of Single Doses of 5 mg [14C]-DK-AH 269 CL Intravenously and 10 mg [14C]-DK-AH 269 CL as Oral Solution in a Parallel-group Design in 12 Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-15
Enrollment: 12
Sex: MALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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 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

Primary outcomes:
measure: Maximum measured concentration of the analytes in plasma (Cmax)
timeFrame: Up to 96 hours after start of treatment
measure: Area under the concentration-time curve of the analytes in plasma (AUC)
timeFrame: Up to 96 hours after start of treatment
measure: Time from dosing to the maximum concentration of the analytes in plasma (tmax)
timeFrame: Up to 96 hours after start of treatment
measure: Terminal rate constant of the analytes in plasma (λz)
timeFrame: Up to 96 hours after start of treatment
measure: Terminal half-life of the analytes in plasma (t1/2)
timeFrame: Up to 96 hours after start of treatment
measure: Mean residence time of the analytes in the body after intravenous administration (MRT)
timeFrame: Up to 96 hours after start of treatment
measure: Mean residence time of the analytes in the body after oral administration (MRTpo)
timeFrame: Up to 96 hours after start of treatment
measure: Apparent clearance of the analytes in plasma following extravascular administration (CL/F)
timeFrame: Up to 96 hours after start of treatment
measure: Total clearance of the analytes in plasma following intravascular administration (CL)
timeFrame: Up to 96 hours after start of treatment
measure: Apparent volume of distribution of the analytes during the terminal phase λz following extravascular administration (Vz/F)
timeFrame: Up to 96 hours after start of treatment
measure: Volume of distribution at steady state (Vss)
timeFrame: Up to 96 hours after start of treatment
measure: Fraction of analytes eliminated in urine from 0 to the time of the last quantifiable data point (fe0-tz)
timeFrame: Up to 120 hours after start of treatment
measure: Fraction of analytes eliminated in faeces from 0 to the time of the last quantifiable data point (fefaeces,0-tz)
timeFrame: Up to 120 hours after start of treatment
measure: Renal clearance of the analytes from 0 to the time of the last quantifiable data point (CLR,0-tz)
timeFrame: Up to 120 hours after start of treatment
measure: Fraction of dose absorbed, based on radioactivity data (Fa)
timeFrame: Up to 96 hours after start of treatment
measure: Absolute bioavailability of the analytes after oral administration (F)
timeFrame: Up to 96 hours after start of treatment
measure: Ratio of CBlood cells/Cplasma [14C]-radioactivity
timeFrame: Up to 96 hours after start of treatment
measure: Number of patients with clinically significant findings in vital signs
timeFrame: up to 12 days after last drug administration
measure: Number of patients with clinically significant findings in 12-lead ECG
timeFrame: up to 12 days after last drug administration
measure: Number of patients with clinically significant findings in 2-lead ECG (telemetry)
timeFrame: up to 90 minutes after start of treatment
measure: Clinically significant changes from baseline in physical examination
timeFrame: Pre-dose, and 12 days after last drug administration
measure: Occurrence of visual phenomena
timeFrame: up to 120 hours after start of treatment
measure: Number of patients with clinically significant findings in clinical laboratory tests
timeFrame: up to 12 days after last drug administration
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: