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- Essai clinique NCT00703547
A First Time in Human Study of GSK586529 in Healthy Volunteers
21 août 2017 mis à jour par: GlaxoSmithKline
A Single Blind, Randomized, Placebo Controlled, Crossover Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single Oral Escalating Doses of GSK586529 in Healthy Volunteers
A single blind, randomized, placebo-controlled, crossover study in twenty four healthy male subjects.
Subjects will be divided into two cohorts with alternate panel design.
The study is investigating the safety, tolerability and pharmacokinetics of single oral escalating doses of GSK586529.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
21
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, NW10 7NS
- 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 45 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Homme
La description
Inclusion Criteria:
- Healthy males aged 18-45 years, inclusive.
- Healthy subjects, defined as individuals who are free from clinically significant illness or disease as determined by their (and familial) medical and psychiatric history, physical examination, laboratory studies, and other tests.
- Body weight >/= 50 kg (110 lbs) and BMI within the range 18.5-29.9 kg/m2 inclusive.
- Demonstrates no evidence of active disease, physical or mental impairment.
- Self-administered Beck Depression Inventory II scale total score no greater than 9, and suicide question score of zero.
- Non-smoker (abstinence from smoking for at least 6 months before the start of the study).
- Normal electrocardiogram (subjects must have no clinically significant abnormalities on a 12-lead ECG and a 24 hour Holter ECG).
- Read, comprehend, and write English at a sufficient level to complete study-related materials.
Exclusion Criteria:
- As a result of any of the medical interview, physical examination, evaluation of mental state and psychiatric history or screening investigations the physician responsible considers the subject unfit for the study.
- The subject has a positive pre-study drug/alcohol screen.
- A positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody
- The subject has a history of psychiatric illness.
- Any history of suicidal attempts or behavior.
- Abuse of alcohol defined as an average weekly intake of greater than 21 units or an average daily intake of greater than three units..
- Consumption of grapefruit juice or grapefruit within 14 days prior to the first dose of study medication.
- Any subject who is not prepared to eat the standard meals provided by the clinic or is a vegetarian.
- Any history of an endocrine disorder including, but not limited to, diabetes or disorders of the hypothalamus, pituitary, adrenal, or thyroid glands, or gonadal disorder or dysfunction of the reproductive organs.
- Clinically significant abnormal; total and free testosterone, LH, FSH, ACTH or cortisol, or TSH or T4 values at screening/baseline
- LFTs elevated
- Any other clinically significant laboratory abnormality
- The subject has a screening ECG with parameters outside ranges defined in the protocol will also be excluded.
- History of long QT syndrome (personal or family) or other cardiac conduction disorder, or other clinically significant cardiac disease.
- The subject has received an investigational drug or participated in any other research trial within 3 months or 5 half-lives, or twice the duration of the biological effect of any drug(whichever is longer) prior to the first dose of study medication.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John'sWort) 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 sponsor the medication will not interfere with the study procedures or compromise subject safety.
- History or presence of allergy to the study drug or drugs of this class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
- Donation of more than 500 mL blood within the 3 months before dosing.
- An unwillingness of male subjects to abstain from sexual intercourse with pregnant or lactating women from the time of the first dose of study medication until 90 days following administration of the last dose of study medication
- An unwillingness of the male subject to use a condom/spermicide in addition to having their female partner use another form of contraception if the woman could become pregnant from the time of the first dose of study medication until 90 days following administration of the last dose of study medication.
- Current or recent (within one year) gastrointestinal disease; a history of malabsorption, esophageal reflux, peptic ulcer disease, irritable bowel syndrome; frequent (more than once a week) occurrence of heartburn; or any surgical intervention (e.g., cholecysectomy) which would be expected to influence the absorption of drugs.
- Average daily caffeine intake equivalent to > 4 cups of coffee or > 6 cups of tea.
- A semi-supine systolic blood pressure less than 90mmHg or greater than 140mmHg or a semi-supine diastolic blood pressure of less than 60mmHg or greater than 90mmHg; or a radial pulse rate less than 40bpm or more than 90bpm.
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: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Subjects receiving treatment in cohort 1
Subjects will receive one of the following sequences; ABDF,BADF, BDAF or BDFA (A=Placebo, B= GSK586529 dose 1 (3 milligrams), D = GSK586529 dose 3, F = GSK586529 dose 5).
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GSK586529 will be provided as white gelatin capsule with a dose of 3 milligrams.
GSK586529 will be provided as a yellow film-coated tablets for oral administration at three different strengths 10 milligrams, 60 milligrams and 120 milligrams.
Placebo tablets and capsules will be provided to subjects.
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Expérimental: Subjects receiving treatment in cohort 2
Subjects will receive one of the following sequences; ACEG,CAEG, CEAG or CEGA (A = Placebo, C= GSK586529 dose 2, E = GSK586529 dose 4, G = GSK586529 dose 6)
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GSK586529 will be provided as white gelatin capsule with a dose of 3 milligrams.
GSK586529 will be provided as a yellow film-coated tablets for oral administration at three different strengths 10 milligrams, 60 milligrams and 120 milligrams.
Placebo tablets and capsules will be provided to subjects.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Pharmacokinetics
Délai: Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
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Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Blood levels of GSK586529 to determine pharmacokinetic parameters
Délai: Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
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Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
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Urinary recovery of GSK586529
Délai: Pre-dose, 0-6, 6-12, 12-24, 24-48, 48-72 and 72-96 hours post-dose
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Pre-dose, 0-6, 6-12, 12-24, 24-48, 48-72 and 72-96 hours post-dose
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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)
28 janvier 2008
Achèvement primaire (Réel)
11 avril 2008
Achèvement de l'étude (Réel)
11 avril 2008
Dates d'inscription aux études
Première soumission
14 avril 2008
Première soumission répondant aux critères de contrôle qualité
20 juin 2008
Première publication (Estimation)
23 juin 2008
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
22 août 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
21 août 2017
Dernière vérification
1 août 2017
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CRZ107432
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 .