Metabolism and Pharmacokinetics of [14C]-DK-AH 269 CL in 12 Healthy Male Volunteers
13 ottobre 2014 aggiornato da: Boehringer Ingelheim
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
- 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
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
12
Fase
- Fase 1
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 50 anni a 65 anni (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Maschio
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: [14C]-DK-AH 269 CL intravenous
|
|
|
Sperimentale: [14C]-DK-AH 269 CL oral
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Maximum measured concentration of the analytes in plasma (Cmax)
Lasso di tempo: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
|
|
Area under the concentration-time curve of the analytes in plasma (AUC)
Lasso di tempo: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
|
|
Time from dosing to the maximum concentration of the analytes in plasma (tmax)
Lasso di tempo: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
|
|
Terminal rate constant of the analytes in plasma (λz)
Lasso di tempo: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
|
|
Terminal half-life of the analytes in plasma (t1/2)
Lasso di tempo: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
|
|
Mean residence time of the analytes in the body after intravenous administration (MRT)
Lasso di tempo: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
|
|
Mean residence time of the analytes in the body after oral administration (MRTpo)
Lasso di tempo: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
|
|
Apparent clearance of the analytes in plasma following extravascular administration (CL/F)
Lasso di tempo: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
|
|
Total clearance of the analytes in plasma following intravascular administration (CL)
Lasso di tempo: Up to 96 hours after start of treatment
|
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)
Lasso di tempo: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
|
|
Volume of distribution at steady state (Vss)
Lasso di tempo: Up to 96 hours after start of treatment
|
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)
Lasso di tempo: Up to 120 hours after start of treatment
|
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)
Lasso di tempo: Up to 120 hours after start of treatment
|
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)
Lasso di tempo: Up to 120 hours after start of treatment
|
Up to 120 hours after start of treatment
|
|
|
Fraction of dose absorbed, based on radioactivity data (Fa)
Lasso di tempo: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
|
|
Absolute bioavailability of the analytes after oral administration (F)
Lasso di tempo: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
|
|
Ratio of CBlood cells/Cplasma [14C]-radioactivity
Lasso di tempo: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
|
|
Number of patients with clinically significant findings in vital signs
Lasso di tempo: up to 12 days after last drug administration
|
blood pressure, heart rate
|
up to 12 days after last drug administration
|
|
Number of patients with clinically significant findings in 12-lead ECG
Lasso di tempo: up to 12 days after last drug administration
|
up to 12 days after last drug administration
|
|
|
Number of patients with clinically significant findings in 2-lead ECG (telemetry)
Lasso di tempo: up to 90 minutes after start of treatment
|
up to 90 minutes after start of treatment
|
|
|
Clinically significant changes from baseline in physical examination
Lasso di tempo: Pre-dose, and 12 days after last drug administration
|
Pre-dose, and 12 days after last drug administration
|
|
|
Occurrence of visual phenomena
Lasso di tempo: up to 120 hours after start of treatment
|
questionnaire
|
up to 120 hours after start of treatment
|
|
Number of patients with clinically significant findings in clinical laboratory tests
Lasso di tempo: up to 12 days after last drug administration
|
up to 12 days after last drug administration
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 marzo 2004
Completamento primario (Effettivo)
1 aprile 2004
Date di iscrizione allo studio
Primo inviato
13 ottobre 2014
Primo inviato che soddisfa i criteri di controllo qualità
13 ottobre 2014
Primo Inserito (Stima)
15 ottobre 2014
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
15 ottobre 2014
Ultimo aggiornamento inviato che soddisfa i criteri QC
13 ottobre 2014
Ultimo verificato
1 ottobre 2014
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 503.209
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .