Metabolism and Pharmacokinetics of [14C]-DK-AH 269 CL in 12 Healthy Male Volunteers
13 octobre 2014 mis à jour par: 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
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
12
Phase
- La phase 1
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
50 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Homme
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: [14C]-DK-AH 269 CL intravenous
|
|
|
Expérimental: [14C]-DK-AH 269 CL oral
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Maximum measured concentration of the analytes in plasma (Cmax)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
|
|
Volume of distribution at steady state (Vss)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: Up to 96 hours after start of treatment
|
Up to 96 hours after start of treatment
|
|
|
Ratio of CBlood cells/Cplasma [14C]-radioactivity
Délai: 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
Délai: 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
Délai: 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)
Délai: up to 90 minutes after start of treatment
|
up to 90 minutes after start of treatment
|
|
|
Clinically significant changes from baseline in physical examination
Délai: Pre-dose, and 12 days after last drug administration
|
Pre-dose, and 12 days after last drug administration
|
|
|
Occurrence of visual phenomena
Délai: 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
Délai: up to 12 days after last drug administration
|
up to 12 days after last drug administration
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
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Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mars 2004
Achèvement primaire (Réel)
1 avril 2004
Dates d'inscription aux études
Première soumission
13 octobre 2014
Première soumission répondant aux critères de contrôle qualité
13 octobre 2014
Première publication (Estimation)
15 octobre 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
15 octobre 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 octobre 2014
Dernière vérification
1 octobre 2014
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 503.209
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