- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02579707
Food Effect Study of AG120 in Healthy Subjects
28 novembre 2016 mis à jour par: Agios Pharmaceuticals, Inc.
A Phase 1, Open-Label, Randomized, 2-Period Crossover Study To Evaluate The Effect Of Food On AG-120 Pharmacokinetics Following Single Oral Dose Administration To Healthy Subjects
This will be a 2-part study.
PART 1 is an open-label, randomized, food effect study of AG-120.
Subjects will be enrolled to a fed/fasted or fasted/fed treatment sequence in a 2-period crossover design.
PART 2 is an open-label study to determine the safety and PK parameters of a single 1000-mg oral dose of AG-120.
Aperçu de l'étude
Type d'étude
Interventionnel
Inscription (Réel)
36
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
-
-
Wisconsin
-
Madison, Wisconsin, États-Unis, 53704
- Research Site
-
-
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 55 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- males or females, aged 18 to 55 years, inclusive
- within body mass index (BMI) range of 18 to 33 kg/m2, inclusive
- in good health, determined by absence of clinically significant findings from medical history, 12-lead ECG, and vital signs
- fasted clinical laboratory values within the normal reference range for the test laboratory, unless deemed not clinically significant by the Investigator. (Calcium, magnesium, and potassium levels within normal ranges)
- negative test for selected drugs of abuse and cotinine at Screening (does not include alcohol) and at Check-in of Period 1 (Parts 1 and 2) and Period 2 (Part 1) (does include alcohol via breathalyzer)
- negative hepatitis panel (including hepatitis B surface antigen and hepatitis C virus antibody) and negative human immunodeficiency virus (HIV) antibody screens
- female subjects with reproductive potential must agree to undergo medically supervised pregnancy test prior to study drug administration. Pregnancy tests will be performed at Screening and confirmed negative at each Check-in
- females of reproductive potential must agree to abstain from sexual intercourse or to use 2 highly effective forms of contraception from the time of giving informed consent, during the study, and for 90 days following the last dose of AG-120.
- males must either be sterile or agree to use 2 of the following approved methods of contraception from time of giving informed consent until 90 days following the last dose administration. Subjects will refrain from sperm donation from time of giving informed consent until 90 days following the last dose administration
- able to comprehend and willing to sign an Informed Consent Form (ICF)
Exclusion Criteria:
- history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator)
- history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator
- history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs except that appendectomy and hernia repair will be allowed
- history or presence of an abnormal ECG, which, in the Investigator's opinion, is clinically significant. QTcF values must be within ranges indicated in inclusion criteria #3
- history of alcoholism or drug addiction within 2 years before first dose administration, or positive drug screening test reflecting consumption of illicit drugs or positive alcohol screen at each Check-in
- use of any tobacco- or nicotine-containing products (including but not limited to cigarettes, e-cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to Screening through Study Completion, or positive cotinine screen at Screening or each Check-in
- unwilling to refrain from strenuous exercise from 48 hours prior to each Check-in and during the period of confinement at the Clinical Research Unit and otherwise maintain their normal level of physical activity throughout the entire study (ie, will not begin a new exercise program nor participate in any unusually strenuous physical exertion)
- participation in any other clinical trial in which an investigational study drug was administered within 5 half-lives or 30 days from Screening, whichever is longer
- use of hormonal oral, implantable, injectable, or transdermal contraceptives from the time of signing the ICF (females only) until 90 days after the last dose administration
- use of any prescription medications/products within 14 days prior to initial Check-in through Study Completion, unless deemed acceptable by the Investigator
- use of any over-the-counter, nonprescription preparations including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations, within 7 days prior to initial Check-in through Study Completion, unless deemed acceptable by the Investigator
- poor peripheral venous access
- donation of blood or plasma within 8 weeks before first dose administration through Study Completion
- receipt of blood products within 2 months prior to initial Check-in and for at least 28 days following the last dose of study drug
- any acute or chronic condition that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study
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 |
---|---|
Comparateur actif: Treatment A: Unfed
Treatment A: Single oral dose of AG-120 at Hour 0 on Day 1, following a 10-hour overnight fast.
|
AG120 in fed and fasted conditions.
Part 2- AG120 single dose exposure
|
Comparateur actif: Treatment B: Fed
Treatment B: Single oral dose of AG-120 at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast.
|
AG120 in fed and fasted conditions.
Part 2- AG120 single dose exposure
|
Expérimental: Part 2 Single Dose
PART 2 is an open-label study to determine the safety and PK parameters of a single 1000-mg oral dose of AG-120.
|
AG120 in fed and fasted conditions.
Part 2- AG120 single dose exposure
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Cmax
Délai: Day 1 predose (for each period as applicable) (0 hour [approximately 45 minutes prior to dose]) and 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 48, 72, 120, 168, 240, 336, and 504 hours post dose.
|
Maximum observed concentration of AG-120
|
Day 1 predose (for each period as applicable) (0 hour [approximately 45 minutes prior to dose]) and 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 48, 72, 120, 168, 240, 336, and 504 hours post dose.
|
Incidence of adverse events
Délai: 22 days
|
Assessment of adverse events
|
22 days
|
Tmax
Délai: Day 1 predose (for each period as applicable) (0 hour [approximately 45 minutes prior to dose]) and 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 48, 72, 120, 168, 240, 336, and 504 hours post dose.
|
Time of maximum concentration of AG-120
|
Day 1 predose (for each period as applicable) (0 hour [approximately 45 minutes prior to dose]) and 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 48, 72, 120, 168, 240, 336, and 504 hours post dose.
|
AUC0-t
Délai: Day 1 predose (for each period as applicable) (0 hour [approximately 45 minutes prior to dose]) and 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 48, 72, 120, 168, 240, 336, and 504 hours post dose.
|
Area under the concentration-time curve from Hour 0 to the last measurable concentration
|
Day 1 predose (for each period as applicable) (0 hour [approximately 45 minutes prior to dose]) and 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 48, 72, 120, 168, 240, 336, and 504 hours post dose.
|
AUC0-infinity
Délai: Day 1 predose (for each period as applicable) (0 hour [approximately 45 minutes prior to dose]) and 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 48, 72, 120, 168, 240, 336, and 504 hours post dose.
|
Area under the concentration-time curve extrapolated to infinity
|
Day 1 predose (for each period as applicable) (0 hour [approximately 45 minutes prior to dose]) and 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 48, 72, 120, 168, 240, 336, and 504 hours post dose.
|
t1/2
Délai: Day 1 predose (for each period as applicable) (0 hour [approximately 45 minutes prior to dose]) and 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 48, 72, 120, 168, 240, 336, and 504 hours post dose.
|
Apparent terminal elimination half-life
|
Day 1 predose (for each period as applicable) (0 hour [approximately 45 minutes prior to dose]) and 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 48, 72, 120, 168, 240, 336, and 504 hours post dose.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chaise d'étude: Sam Agresta, MD, Agios Pharmaceuticals, Inc.
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
1 octobre 2015
Achèvement primaire (Réel)
1 février 2016
Achèvement de l'étude (Réel)
1 juin 2016
Dates d'inscription aux études
Première soumission
15 octobre 2015
Première soumission répondant aux critères de contrôle qualité
16 octobre 2015
Première publication (Estimation)
20 octobre 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
29 novembre 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
28 novembre 2016
Dernière vérification
1 novembre 2016
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- AG120-C-004
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 En bonne santé
-
AstraZenecaParexelComplété