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Single Dose Study of PF-04991532 in Healthy Subjects Phase I 18 Dose unique

Terminé
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT01102673 a été une étude interventionnel pour Diabète sucré, Diabète sucré de type 2, Troubles du Métabolisme du Glucose. Son statut actuel est : terminé. L'étude a commencé le 1 avril 2010, avec un objectif de recruter 18 participants. Dirigée par Pfizer, l'étude s'est terminée le 1 juin 2010. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 5 août 2010.
Résumé succinct
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK) and preliminary food effect of PF-04991532 following single escalating oral doses in healthy adult subjects.
Description détaillée
Safety/Tolerability and PK
Titre officiel

A Phase 1 Placebo-Controlled Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Food Effect of Single Escalating Oral Doses of PF-04991532 in Healthy Adult Subjects

Pathologies
Diabète sucréDiabète sucré de type 2Troubles du Métabolisme du Glucose
Autres identifiants de l'étude
  • B2611001
Numéro NCT
NCT01102673
Date de début (réel)
2010-04
Dernière mise à jour publiée
2010-08-05
Date de fin (estimée)
2010-06
Inscription (estimée)
18
Type d'étude
Interventionnel
PHASE
Phase I
Statut
Terminé
Mots clés
phase 1
safety and tolerability
PK
T2DM
type 2 diabetes mellitus
Méthode d'allocation
Randomisé
Modèle d'intervention
Étude croisée
Masquage
Double aveugle
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalPF-04991532
This will be a crossover study with 2 cohorts and an interleaving design with placebo substitution. The study will be conducted over 4 treatment periods in Cohort 1 (n=9) and over 3 treatment periods in Cohort 2 (n=9). Six subjects will be allocated to receive PF-04991532 and three subjects will be allocated to receive placebo treatment during each dosing period, except for the 4th period of Cohort 1. The 4th period ...Afficher plus
PF-04991532
The tentative dosing schedule is 30, 100, 300, 600, 1200, and 2000 mg. Doses shown may be adjusted upwards or downwards and may be adjusted to include intermediate doses. All doses will be administered as extemporaneously-prepared powder in capsule (PIC) formulation.
Comparateur placeboPlacebo
This will be a crossover study with 2 cohorts and an interleaving design with placebo substitution. The study will be conducted over 4 treatment periods in Cohort 1 (n=9) and over 3 treatment periods in Cohort 2 (n=9). Six subjects will be allocated to receive PF-04991532 and three subjects will be allocated to receive placebo treatment during each dosing period, except for the 4th period of Cohort 1. The 4th period ...Afficher plus
PLACEBO
Placebo to match PF-04991532 will be provided
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
Safety and Tolerability Endpoints: physical exams, AE monitoring, 12-lead ECGs, continuous cardiac monitoring, vital sign and clinical safety laboratory (including frequent glucose assessments via glucometer) measurements.
1 month
PK Endpoints: AUC(0-inf), AUC(0-last), AUC(0-24), Cmax, Tmax, CL/F, Vz/F and half-life (t1/2), as the data permit.
1 month
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
none-see my comment
Critères d'éligibilité

Âges éligibles
Adulte
Âge minimum
18 Years
Sexes éligibles
Tous
Accepte les volontaires en bonne santé
Oui
  • Healthy male and/or female (non child-bearing potential) subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
  • Body Mass Index (BMI) of 17.5 to 35.5 kg/m2; and a total body weight >50 kg (110 lbs).

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
  • Use of tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
  • Self-reported history of hypoglycemia, or fasting laboratory glucose value </=80 mg/dL at screening or Day 0 of Period 1, confirmed by a single repeat if deemed necessary.
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1 Centres de l'étude dans 1 pays

Connecticut

Pfizer Investigational Site, New Haven, Connecticut, 06511, United States