- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00866515
Drug Interaction Study to Investigate Co-administration of GW642444M With Ketoconazole
13 juillet 2017 mis à jour par: GlaxoSmithKline
A Double-blind, Placebo-controlled, Randomised, 2-way Crossover Drug Interaction Study to Investigate the Pharmacokinetic and Pharmacodynamic Effects Following Co-administration of GW642444M With Ketoconazole
This will be a single-centre, randomised, double blind, placebo controlled, two-way crossover study in healthy male and female subjects.
There will be two treatment periods each consisting of 7 days.
During each treatment period subjects will receive single doses of ketoconazole or placebo on the morning of days 1-6 with a single dose of GW642444M on the morning of Day 5.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
This will be a single-centre, randomised, double blind, placebo controlled, two-way crossover study in healthy male and female subjects.
There will be two treatment periods each consisting of 7 days.
During each treatment period subjects will receive single doses of ketoconazole or placebo on the morning of days 1-6 with a single dose of GW642444M on the morning of Day 5.
Type d'étude
Interventionnel
Inscription (Réel)
20
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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New South Wales
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Randwick, New South Wales, Australie, 2031
- GSK Investigational Site
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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
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included at the discretion of the Investigator only if the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- A female subject is eligible to participate if she is of:
- Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation, hysterectomy or bilateral oophorectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8.1 if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
- Child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until after the final follow-up visit has been completed.
- Body weight ≥ 50 kg and BMI within the range 19 - 29.9 kg/m2 (inclusive).
- Demonstrated ability to use the inhaler device in a satisfactory and repeatable manner
- Subjects who are current non-smokers, who have not used any inhaled tobacco products (snuff is permitted) in the 12 month period preceding the screening visit and who have a pack history of ≤ 10 pack years.
- No significant abnormality on 12-lead ECG at screening, including the following requirements:
- Ventricular rate ≥ 40 beats per minute
- PR interval ≥ 120 and ≤ 210 msec
- Q waves < 30 msec (up to 50 msec permitted in lead III only)
- QRS interval to be ≥ 60 msec and ≤ 120 msec
- QTc interval must be < 450 msec (QTcB or QTcF; machine or manual reading) based on an average from three ECGs obtained over a brief recording period
- FEV1 ≥ 80% predicted and a FEV1 / FVC ratio ≥ 0.7 at screening
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Exclusion Criteria:
- As a result of medical interview, physical examination or screening investigations, the principle investigator or delegate physician deems the subject unsuitable for the study.
- Systolic blood pressure which is outside the range 90 to 140 mmHg, diastolic blood pressure outside the range 50 to 90 mmHg or heart rate outside the range 40 to 90 bpm.
- The subject has been treated for or diagnosed with depression within six months of screening or has a history of significant psychiatric illness.
- The subject has any history of breathing problems in adult life (i.e. history of asthmatic symptomatology).
- A clinically significant abnormality on standard pulmonary function testing, or any other finding that would prevent satisfactory administration of the inhaled study medication.
- Any contraindication to the administration of ketoconazole, as described in the current [NIZORAL Product Information, Janssen-Cilag Pty Limited, 2008].
- History of sensitivity to any of the study medications, or components thereof (including milk protein) or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Currently taking regular (or a course of) medication whether prescribed or not, with the exception of those permitted medications listed in Section 8.1 and Section 9.1.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- History of regular alcohol consumption within 6 months of the study defined as:
- An average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~250 mL) of beer, 1 glass (100 mL) of wine or 1 measure (30 mL) of spirits.
- The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication.
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- The subject has donated a unit of blood within the previous 16 weeks or intends to donate within 16 weeks after completing the study.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- The subject has tested positive for HIV antibodies.
- The subject has a positive pre-study urine drug screen/ alcohol breath test. A minimum list of drugs that will be screened for include Amphetamines, Barbiturates, Cocaine, Opiates, Cannabinoids and Benzodiazepines.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subjects who have a screening haemoglobin value < 110 mg/L.
- Pregnant (as determined by positive (serum or urine) hCG test at screening or prior to dosing) or lactating females.
- Subject is mentally or legally incapacitated.
- CO breath monitoring indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
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 croisée
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Active
Ketoconazole 400mg OD days 1-6
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Ketoconazole 400mg OD days 1-6, GW642444M 25ug single dose on D5
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Comparateur placebo: Placebo
Placebo OD for 1 to 6 days
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Placebo to match D1-6 + GW642444M 25ug single dose on D5
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Supine heart rate and blood potassium levels
Délai: Day 5
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Day 5
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Plasma GW642444M concentrations
Délai: Day 5
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Day 5
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Reported Adverse Events
Délai: treatment periods
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treatment periods
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
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 (Réel)
22 décembre 2008
Achèvement primaire (Réel)
27 mars 2009
Achèvement de l'étude (Réel)
27 mars 2009
Dates d'inscription aux études
Première soumission
22 janvier 2009
Première soumission répondant aux critères de contrôle qualité
19 mars 2009
Première publication (Estimation)
20 mars 2009
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
18 juillet 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 juillet 2017
Dernière vérification
1 juillet 2017
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies des voies respiratoires
- Maladies pulmonaires
- Maladies pulmonaires obstructives
- Maladie pulmonaire obstructive chronique
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Agents anti-infectieux
- Inhibiteurs d'enzymes
- Hormones, substituts hormonaux et antagonistes hormonaux
- Inhibiteurs du cytochrome P-450 CYP3A
- Inhibiteurs des enzymes du cytochrome P-450
- Antagonistes hormonaux
- Agents antifongiques
- Inhibiteurs de la synthèse des stéroïdes
- Inhibiteurs de la 14-alpha déméthylase
- Kétoconazole
Autres numéros d'identification d'étude
- 112205
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Données/documents d'étude
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Formulaire de consentement éclairé
Identifiant des informations: 112205Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
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Ensemble de données de participant individuel
Identifiant des informations: 112205Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
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Plan d'analyse statistique
Identifiant des informations: 112205Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
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Spécification du jeu de données
Identifiant des informations: 112205Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
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Formulaire de rapport de cas annoté
Identifiant des informations: 112205Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
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Protocole d'étude
Identifiant des informations: 112205Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
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Rapport d'étude clinique
Identifiant des informations: 112205Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Ketoconazole + GW642444M
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GlaxoSmithKlineComplétéAsthmeÉtats-Unis, Argentine, Pologne, Fédération Russe, Belgique, Canada, Chili, France, Allemagne, Corée, République de, Pays-Bas, Pérou, Philippines, Afrique du Sud, Suède, Thaïlande
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GlaxoSmithKlineComplétéMaladie pulmonaire obstructive chroniqueRoyaume-Uni
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GlaxoSmithKlineComplétéMaladie pulmonaire obstructive chroniqueAustralie, Nouvelle-Zélande
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GlaxoSmithKlineComplétéMaladie pulmonaire obstructive chroniqueAllemagne
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GlaxoSmithKlineComplété
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GlaxoSmithKlineComplété
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GlaxoSmithKlineComplétéAsthmeSuède, Australie, Nouvelle-Zélande
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GlaxoSmithKlineComplétéMaladie pulmonaire obstructive chroniqueTchéquie
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GlaxoSmithKlineComplété
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GlaxoSmithKlineComplétéAsthmeRoyaume-Uni, Allemagne, Nouvelle-Zélande