A Healthy Volunteer Study to Investigate the Relative Bioavailability of Two Forms of GSK598809 Capsules.
2 août 2017 mis à jour par: GlaxoSmithKline
An Open Label, Randomised, Single Dose, Three-way Crossover Study to Investigate the Relative Bioavailability of a 100mg Capsule Compared to Four 25mg GSK598809 Capsules and the Effect of Food on the Pharmacokinetics of the 100mg Capsule in Healthy Male and Female Volunteers.
Study to compare PK of a new 100mg capsule with four 25mg capsules.
This is required because we plan to have only single capsules administered in the later phase clinical trials but we have not had a 100mg strength before.
As this is a new previously untested strength we need to ensure that the PK is similar to that achieved using 4 x 25mg.
The study will also assess the effect of high fat food on the PK of the 100mg capsule.
The study is planned to consist of a single part , with three dosing periods, periods 1-3 consisting of 16 subjects.
There will be a week wash out between each dose.
In the three dosing periods subjects will either received 4x25 mg GSK598809 capsule in a fasted state, 100mg capsule in a fasted state or 100mg GSK598809 capsule in a fed state.
Subjects will return to the centre for follow-up 7-14 days after the final dose.
It is expected that the total duration of the study should be approximately eight weeks.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
16
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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London, Royaume-Uni, SE1 1YR
- 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:
- Healthy as determined by responsible physician.
- Male or female between 18 to 65 years old.
- Females of non-child bearing potential and females of child-bearing potential that agree to use appropriate method of contraception for appropriate amount of time.
- Males that agree to use appropriate method of contraception for appropriate amount of time.
- Neither too fat nor too thin.
- Capable of giving written informed consent and being compliant with requirements within the informed consent.
Exclusion:
- Any current medical or psychiatric illness.
- Any history of chronic medical or psychiatric illnesses.
- Previous or current alcohol or drug abuse/dependence including nicotine.
- Female subjects must not be breastfeeding or been breastfeeding for a month.
- Serum prolactin exceeding normal range.
- Personal or family history of prolonged QTc syndrome.
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: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Subjects receiving treatment sequence ABC
Eligible subjects will receive treatment sequence ABC; A= 4x25 milligrams GSK598809 capsule given in fasted state, B= 100 milligrams GSK598809 capsule in given fasted state and C= 100 milligrams GSK598809 capsule given in fed state.
The treatment sequence will be followed by at least a 7-day wash-out period between each dose.
|
GSK598809 new formulation will be available as an immediate release capsule with a single dose of 100 milligrams, administered orally with 240 milliliters of water.
GSK598809 old formulation will be available as an immediate release capsule with a single dose of 25 milligrams, administered orally with 240 milliliters of water.
|
|
Expérimental: Subjects receiving treatment sequence ACB
Eligible subjects will receive treatment sequence ACB; A= 4x25 milligrams GSK598809 capsule given in fasted state, C= 100 milligrams GSK598809 capsule given in fed state and B= 100 milligrams GSK598809 capsule in given fasted state.
The treatment sequence will be followed by at least a 7-day wash-out period between each dose.
|
GSK598809 new formulation will be available as an immediate release capsule with a single dose of 100 milligrams, administered orally with 240 milliliters of water.
GSK598809 old formulation will be available as an immediate release capsule with a single dose of 25 milligrams, administered orally with 240 milliliters of water.
|
|
Expérimental: Subjects receiving treatment sequence BAC
Eligible subjects will receive treatment sequence BAC; B= 100 milligrams GSK598809 capsule in given fasted state, A= 4x25 milligrams GSK598809 capsule given in fasted state and C= 100 milligrams GSK598809 capsule given in fed state.
The treatment sequence will be followed by at least a 7-day wash-out period between each dose.
|
GSK598809 new formulation will be available as an immediate release capsule with a single dose of 100 milligrams, administered orally with 240 milliliters of water.
GSK598809 old formulation will be available as an immediate release capsule with a single dose of 25 milligrams, administered orally with 240 milliliters of water.
|
|
Expérimental: Subjects receiving treatment sequence BCA
Eligible subjects will receive treatment sequence BCA; B= 100 milligrams GSK598809 capsule in given fasted state, C= 100 milligrams GSK598809 capsule given in fed state and A= 4x25 milligrams GSK598809 capsule given in fasted state.
The treatment sequence will be followed by at least a 7-day wash-out period between each dose.
|
GSK598809 new formulation will be available as an immediate release capsule with a single dose of 100 milligrams, administered orally with 240 milliliters of water.
GSK598809 old formulation will be available as an immediate release capsule with a single dose of 25 milligrams, administered orally with 240 milliliters of water.
|
|
Expérimental: Subjects receiving treatment sequence CAB
Eligible subjects will receive treatment sequence CAB; C= 100 milligrams GSK598809 capsule given in fed state, A= 4x25 milligrams GSK598809 capsule given in fasted state and B= 100 milligrams GSK598809 capsule in given fasted state.
The treatment sequence will be followed by at least a 7-day wash-out period between each dose.
|
GSK598809 new formulation will be available as an immediate release capsule with a single dose of 100 milligrams, administered orally with 240 milliliters of water.
GSK598809 old formulation will be available as an immediate release capsule with a single dose of 25 milligrams, administered orally with 240 milliliters of water.
|
|
Expérimental: Subjects receiving treatment sequence CBA
Eligible subjects will receive treatment sequence CBA; C= 100 milligrams GSK598809 capsule given in fed state, B= 100 milligrams GSK598809 capsule in given fasted state and A= 4x25 milligrams GSK598809 capsule given in fasted state.
The treatment sequence will be followed by at least a 7-day wash-out period between each dose.
|
GSK598809 new formulation will be available as an immediate release capsule with a single dose of 100 milligrams, administered orally with 240 milliliters of water.
GSK598809 old formulation will be available as an immediate release capsule with a single dose of 25 milligrams, administered orally with 240 milliliters of water.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Blood sampling over a period of 96hrs post GSK598809 dosing in the three dosing periods.
Délai: Pre-dose, 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8. 10, 12, 16, 24, 48. 72 and 96 hours
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Pre-dose, 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8. 10, 12, 16, 24, 48. 72 and 96 hours
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Safety and Tolerability: cardiovascular variables, vital signs, clinical labs, movement scales, prolactin, GH and TSH levels over 96 hours post dosing. Continuous adverse event monitoring from dosing until study conclusions.
Délai: Up to 96 hours
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Up to 96 hours
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
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)
2 juillet 2008
Achèvement primaire (Réel)
29 juillet 2008
Achèvement de l'étude (Réel)
29 juillet 2008
Dates d'inscription aux études
Première soumission
4 août 2008
Première soumission répondant aux critères de contrôle qualité
4 août 2008
Première publication (Estimation)
6 août 2008
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
4 août 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
2 août 2017
Dernière vérification
1 août 2017
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- DAN111283
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