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

NCT ID: NCT02264028

Last Updated: 2014-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

[14C]-DK-AH 269 CL intravenous

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

[14C]-DK-AH 269 CL oral

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

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

• 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

503.209

Identifier Type: -

Identifier Source: org_study_id