Metabolism and Pharmacokinetics of [14C]-DK-AH 269 CL in 12 Healthy Male Volunteers

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: [14C]-DK-AH 269 CL, solution for infusion

Drug: [14C]-DK-AH 269 CL, drinking solution

Study type

Interventional

Funder types

Industry

Identifiers

503.209

Details and patient eligibility

About

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

Enrollment

12 patients

Sex

Male

Ages

50 to 65 years old

Volunteers

Accepts Healthy Volunteers

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