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

NCT02264028 | Completed Phase 1

• 1 other identifier: 503.209
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (23)

• 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

  blood pressure, heart rate

  up to 12 days after last drug administration

• 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

  questionnaire

  up to 120 hours after start of treatment

• Number of patients with clinically significant findings in clinical laboratory tests

  up to 12 days after last drug administration

Study Arms (2)

[14C]-DK-AH 269 CL intravenous

ACTIVE COMPARATOR

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

[14C]-DK-AH 269 CL oral

EXPERIMENTAL

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

Interventions

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

[14C]-DK-AH 269 CL intravenous

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

[14C]-DK-AH 269 CL oral

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Solutions

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2014
• First Posted: October 15, 2014
• Study Start: March 1, 2004
• Primary Completion: April 1, 2004
• Last Updated: October 15, 2014

Record last verified: 2014-10