- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02579707
Food Effect Study of AG120 in Healthy Subjects
28. november 2016 opdateret af: 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.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
36
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Wisconsin
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Madison, Wisconsin, Forenede Stater, 53704
- Research Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 55 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Treatment A: Unfed
Treatment A: Single oral dose of AG-120 at Hour 0 on Day 1, following a 10-hour overnight fast.
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AG120 in fed and fasted conditions.
Part 2- AG120 single dose exposure
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Aktiv komparator: 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.
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AG120 in fed and fasted conditions.
Part 2- AG120 single dose exposure
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Eksperimentel: 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.
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AG120 in fed and fasted conditions.
Part 2- AG120 single dose exposure
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Cmax
Tidsramme: 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.
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Maximum observed concentration of AG-120
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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.
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Incidence of adverse events
Tidsramme: 22 days
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Assessment of adverse events
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22 days
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Tmax
Tidsramme: 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.
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Time of maximum concentration of AG-120
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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.
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AUC0-t
Tidsramme: 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.
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Area under the concentration-time curve from Hour 0 to the last measurable concentration
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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.
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AUC0-infinity
Tidsramme: 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.
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Area under the concentration-time curve extrapolated to infinity
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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.
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t1/2
Tidsramme: 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.
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Apparent terminal elimination half-life
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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.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Sam Agresta, MD, Agios Pharmaceuticals, Inc.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2015
Primær færdiggørelse (Faktiske)
1. februar 2016
Studieafslutning (Faktiske)
1. juni 2016
Datoer for studieregistrering
Først indsendt
15. oktober 2015
Først indsendt, der opfyldte QC-kriterier
16. oktober 2015
Først opslået (Skøn)
20. oktober 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
29. november 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. november 2016
Sidst verificeret
1. november 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AG120-C-004
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .