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A Study to Assess the Relative Bioavailability Between Two ASP015K Tablets and the Food Effect of a New Tablet in Healthy Adult Subjects

13 september 2013 bijgewerkt door: Astellas Pharma Global Development, Inc.

A Phase 1, Single-Dose, Open-Label, 3-Period, Randomized Crossover Study to Assess the Relative Bioavailability Between Two ASP015K Tablet Formulations and the Food Effect on a New Tablet Formulation in Healthy Adult Subjects

The purpose of this study is to determine the relative bioavailability of ASP015K under fasting conditions after single-dose administration between a test-tablet formulation and a reference-tablet formulation. This study will also evaluate the food effect on bioavailability of the test formulation, and evaluate the safety and tolerability after single-dose administration of the test- and reference-tablet formulations.

Studie Overzicht

Studietype

Ingrijpend

Inschrijving (Werkelijk)

36

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Maryland
      • Baltimore, Maryland, Verenigde Staten, 21225
        • Parexel - Early Phase Clinical Unit

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 55 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Female subject must be of non-childbearing potential (i.e., post-menopausal [defined as at least 1 year without menses prior to screening], or documented surgically sterile or status post hysterectomy [at least 1 month prior to screening]).
  • Female subject must have a negative pregnancy test at screening and day -1 of treatment period 1.
  • Female subject must not donate ova starting at screening and throughout the study period, and for 90 days after the final study drug administration.
  • Male subject and his female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at screening and continue throughout the study period and for 90 days after final study drug administration.
  • Male subject must not donate sperm starting at screening and throughout the study period and for 90 days after final study drug administration.
  • Subject has a Body Mass Index (BMI) range of 18.5-32.0 kg/m2, inclusive, and must weigh at least 50 kg at screening.

Exclusion Criteria:

  • Female subject who has been pregnant within 6 months before screening assessment or breast feeding within 3 months before screening.
  • Subject has a known or suspected hypersensitivity to ASP015K, or any components of the formulation used.
  • Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to first clinic check-in.
  • Subject has used any prescribed or non-prescribed drugs (including vitamins, natural and herbal remedies, e.g., St. John's Wort) in the 2 weeks prior to study drug administration, with the exception of hormone replacement therapy (HRT), intermittent acetaminophen (to a maximum of 2 g/day).
  • Subject has smoked or has used tobacco-containing products and nicotine or nicotine-containing products in the past six months prior to screening.
  • Subject has a history of consuming more than 14 units of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical substance abuse within past 2 years prior to screening (Note: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits) prior to day -1 of treatment period 1.
  • Subject has had any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic check-in on day -1 of treatment period 1.
  • Subject has a positive test for hepatitis B surface antigen (HBsAg), anti-hepatitis A virus (HAV) (Immunoglobulin [Ig] M), anti-hepatitis C virus (HCV), hepatitis B core antibody, or anti-human immunodeficiency virus (HIV) type 1 or type 2 at screening.
  • Subject has a positive tuberculosis (TB) skin test, Quantiferon Gold® test or T-SPOT® test at screening.
  • Subject received any vaccine within 60 days prior to study drug administration.
  • Subject has an absolute neutrophil count (ANC) < 2000 cells/mm3 or a creatine phosphokinase (CPK) > 1.5 x ULN at screening or day -1 of treatment period 1.
  • Subject has had major gastrointestinal (GI) surgery or has a medical condition, which may inhibit the absorption and/or metabolism of study drug.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: ASP015K Test Tablet - Fasting Conditions
ASP015K administered as a single tablet under fasting conditions.
oral tablet
Experimenteel: ASP015K Reference Tablet - Fasting Conditions
ASP015K administered via multiple tablets under fasting conditions
oral tablet
Experimenteel: ASP015K Test Tablet -Fed Conditions
ASP015K administered as a single tablet under fed conditions
oral tablet

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pharmacokinetic parameter of ASP015K: Cmax
Tijdsspanne: Day 1-4 of each treatment period
Maximum Concentration (Cmax)
Day 1-4 of each treatment period
Pharmacokinetic parameter of ASP015K: AUClast
Tijdsspanne: Day 1-4 of each treatment period
Area Under the Curve from time zero to the last measurable time (AUClast)
Day 1-4 of each treatment period
Pharmacokinetic parameter of ASP015K: AUCinf
Tijdsspanne: Day 1-4 of each treatment period
Area Under the Curve from time zero extrapolated to infinity (AUCinf)
Day 1-4 of each treatment period

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Composite of pharmacokinetic parameters of ASP015K: tmax, t1/2
Tijdsspanne: Day 1-4 of each treatment period
Time to Maximum Concentration (tmax), apparent terminal elimination half-life (t1/2)
Day 1-4 of each treatment period
Composite of pharmacokinetic parameters of ASP015K metabolites: Cmax, AUClast, AUCinf, tmax, t1/2
Tijdsspanne: Day 1-4 of each treatment period
Day 1-4 of each treatment period
Safety assessed by adverse events, clinical laboratory evaluations, 12-lead ECG measurements, physical examinations and vital sign measurements
Tijdsspanne: Up to Day 4 in each treatment period
Up to Day 4 in each treatment period

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 mei 2013

Primaire voltooiing (Werkelijk)

1 augustus 2013

Studie voltooiing (Werkelijk)

1 augustus 2013

Studieregistratiedata

Eerst ingediend

23 augustus 2013

Eerst ingediend dat voldeed aan de QC-criteria

23 augustus 2013

Eerst geplaatst (Schatting)

28 augustus 2013

Updates van studierecords

Laatste update geplaatst (Schatting)

16 september 2013

Laatste update ingediend die voldeed aan QC-criteria

13 september 2013

Laatst geverifieerd

1 september 2013

Meer informatie

Termen gerelateerd aan deze studie

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Klinische onderzoeken op Gezonde onderwerpen

Klinische onderzoeken op ASP015K

3
Abonneren