- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02306876
A Study To Examine Safety, Pharmacokinetics, And Pharmacodynamic Of Pf 06412562 In Healthy Males
A Randomized,Subject And Investigator Blind, Sponsor Open Placebo Controlled, Parallel Phase 1b Study To Examine The Safety, Pharmacokinetics, And Pharmacodynamic Effects Of Pf-06412562 On Cognitive And Reward/Motivation Domains In Healthy Male Volunteers Selected By Cognitive Phenotype
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This study is designed to investigate the safety, tolerability pharmacokinetics and pharmacodynamic effects of PF-06412562 following multiple dose administration as MR tablets in healthy adult males. The study will be comprised of 2 analytical stages. Both analytical stages will be conducted as randomized, subject and investigator blind, sponsor open, placebo-controlled, parallel design. Study enrollment will be continuous through Stage I and Stage II. Stage I consists of approximately 45 completer subjects (approximately 15 per arm). Stage I is an exploratory hypothesis generation stage. No multiple comparison adjustment will be conducted for the Stage I analysis. The sample size in Stage I is based on operational feasibility. All endpoints including the composite scores will be tested at the end of Stage I. Each PF-06412562 dose (3 mg BID and 15 mg BID) will be compared to the placebo arm for each endpoint. Up to 5 comparisons that meet Stage I decision criteria will be treated as primary comparisons in Stage II (see Data Analysis section). Stage II is a hypothesis testing stage in which multiple comparisons will be adjusted and overall type I error rate will be controlled across all primary comparisons. Stage II will be formally powered to study those endpoints/doses most likely to demonstrate the strongest pharmacodynamic signal. Stage II will not exceed 56 completers (~21 in each PF-06412562 arm and ~14 in placebo arm). Study enrollment will be continuous through Stage I and Stage II. The three treatments in both stages include (i) PF-06412562 3 mg BID (ii) PF-06412562 15 mg BID, and (iii) placebo. Separate placebo groups, contemporaneous with the treatment groups, will be recruited for Stage I and Stage II. A total of approximately 101 subjects will be randomly assigned to one of the 3 treatments. If a subject drops out before completing the study, or withdraws for reasons unrelated to the safety of the test treatment, the subject will be replaced at the discretion of the Sponsor in consultation with the investigator. Subjects with fMRI or ERP data that does not pass imaging or ERP data QC will also be replaced.
Subjects will be randomized to a specific treatment arm according to the randomization schedule provided to the site by Pfizer. Two doses of PF-06412562 (3 mg and 15 mg), administered as MR tablets, will be given twice daily (BID) from Day 1 through Day 6. A loading dose of PF-06412562 will be administered as an IR tablet on Day 1 only to facilitate rapid attainment of concentration into the target range. For subjects assigned to the 3 mg BID group, one 3 mg MR tablet and one
1 mg PF-06412562 IR tablet will be administered. For subjects assigned to the 15 mg BID group, one 15 mg MR tablet and one 5 mg IR dose of PF-06412562 will be administered.
On Day 7 only the morning dose will be administered. Subject participation will be approximately 12 days (and 11 nights), excluding screening and follow-up. Screening activities will be completed up to 28 days prior to admission to the study on Day -3. The follow-up visit is conducted approximately 7 to 10 days after the last dose of study drug administration. Medically healthy, right-handed male subjects, aged 18-45 will be screened for working memory capacity, psychiatric disorders and other cognitive/educational constrains. Subjects who meet all entry criteria will be randomized into one of the three treatment arms.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
-
-
California
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Arcadia, California, États-Unis, 91007
- Arcadia MRI & Imaging Center
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Glendale, California, États-Unis, 91206
- California Clinical Trials Medical Group
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Glendale, California, États-Unis, 91206
- Glendale Adventist Medical Center
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Medically healthy
- Male
- Right-handed aged
- 18-45 years
- BMI 17.5 to 35kg/m2.
Exclusion Criteria:
- Females
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of screening and at the time of dosing).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur placebo: Placebo
Placebo BID
|
Placebo
|
Expérimental: PF-06412562 3mg
PF-06412562 3mg BID
|
PF-06412562
Autres noms:
|
Expérimental: PF-06412562 15mg
PF-06412562 15mg BID
|
PF-06412562
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
change from baseline for Columbia Suicide Severity Rating Scale
Délai: Screening, Day 1, Day 7 and Follow-up
|
Columbia Suicide Severity Rating Scale
|
Screening, Day 1, Day 7 and Follow-up
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Cavg: Average plasma PF-06412562 and PF-06663872 concentrations at steady state
Délai: Day 4, 6 and 8
|
Average plasma PF-06412562 and PF-06663872 concentrations for each dose at times 0, 5, and 12 hours on days 4 and 6, as well as 0 hours on Day 8
|
Day 4, 6 and 8
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- B7441004
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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 .
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