Status:
COMPLETED
Metabolism and Pharmacokinetics of [14C]-DK-AH 269 CL in 12 Healthy Male Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
50-65 years
Phase:
PHASE1
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 af...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02264028
Start Date
March 1 2004
Last Update
October 15 2014
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