- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01929577
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 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
36
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Maryland
-
Baltimore, Maryland, Förenta staterna, 21225
- Parexel - Early Phase Clinical Unit
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 55 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: ASP015K Test Tablet - Fasting Conditions
ASP015K administered as a single tablet under fasting conditions.
|
oral tablet
|
|
Experimentell: ASP015K Reference Tablet - Fasting Conditions
ASP015K administered via multiple tablets under fasting conditions
|
oral tablet
|
|
Experimentell: ASP015K Test Tablet -Fed Conditions
ASP015K administered as a single tablet under fed conditions
|
oral tablet
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pharmacokinetic parameter of ASP015K: Cmax
Tidsram: Day 1-4 of each treatment period
|
Maximum Concentration (Cmax)
|
Day 1-4 of each treatment period
|
|
Pharmacokinetic parameter of ASP015K: AUClast
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Composite of pharmacokinetic parameters of ASP015K: tmax, t1/2
Tidsram: 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
Tidsram: 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
Tidsram: Up to Day 4 in each treatment period
|
Up to Day 4 in each treatment period
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2013
Primärt slutförande (Faktisk)
1 augusti 2013
Avslutad studie (Faktisk)
1 augusti 2013
Studieregistreringsdatum
Först inskickad
23 augusti 2013
Först inskickad som uppfyllde QC-kriterierna
23 augusti 2013
Första postat (Uppskatta)
28 augusti 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
16 september 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 september 2013
Senast verifierad
1 september 2013
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 015K-CL-PK09
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