- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01484964
A Single Oral Dose Study to Compare the Bioavailability Between Two Different Tablet Formulations and Assess if There is a Food Effect With the New Formulation
A Phase I, Single-Dose, Open-Label, Three-Period, Randomized, Crossover Study to Compare the Relative Bioavailability Between Two Tablet Formulations of ASP015K and to Assess the Food Effect on a New Formulation in Healthy Volunteers
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
Eligible subjects will be admitted on Day -2 and remain confined on the unit for 20 days. Each subject will receive a single dose of study drug per the defined treatment periods on the morning of Day 1, Day 8 and Day 15. There will be a minimum of 7 days between each consecutive dose group.
For Treatment A, Formulation 1 tablets will be administered within 30 minutes after the start of a standard FDA moderate-fat breakfast. Treatment B, Formulation 2 tablets will be administered in a fasted state. For Treatment C, Formulation 2 tablets will be administered within 30 minutes after the start of a standard FDA moderate-fat breakfast.
Any subject discontinuing the study prior to completion should have all end of study evaluations completed
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
California
-
Glendale, California, Förenta staterna, 91206
- Parexel
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Subject weighs at least 45 kg and has a body mass index (BMI) of 18-32 kg/m2
- Male subject agrees to sexual abstinence, is surgically sterile or is using a medically acceptable method to prevent pregnancy and agrees to continue using this method until 90 days after the last dose of study drug administration
- Male subject agrees to not donate sperm until 90 days after the dose of study drug administration
- Female subject is surgically sterile or is post-menopausal and is not pregnant and is not lactating
- Subject's 12-lead electrocardiogram (ECG) is normal
- Subject must be capable of swallowing multiple tablets
- Subject is willing to take and complete the moderate-fat breakfast within 30 minutes
Exclusion Criteria:
- Subject has a previous history of any clinically significant gastro-intestinal, neurological, renal, hepatic, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease, malignancy excluding non-melanoma skin cancer or any other medical condition
- Subject has had major GI surgery (such as colectomy, cholecystectomy, etc)
- Subject has a history of consuming more than 14 units of alcoholic beverages per week or has a history of alcoholism or drug/chemical/ substance abuse within past 2 years
- Subject has/had a symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week
- Subject has a positive test for hepatitis C antibody, or positive test for hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody
- Subject has a history of the human immunodeficiency virus (HIV) antibody
- Subject has a positive tuberculosis (TB) skin test, Quantiferon Gold test or T-SPOT® test
- Subject received any vaccine within 60 days
- Subject received an experimental agent within 30 days
- Subject has an absolute neutrophil count (ANC) < 2500 cells/mm3
- 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
- Subject has a history of smoking or has used tobacco-containing products and nicotine or nicotine-containing products in the past six months
Studieplan
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Treatment A
ASP015K Formulation 1 with moderate-fat meal
|
oral
|
Experimentell: Treatment B
ASP015K Formulation 2 under fasting conditions
|
oral
|
Experimentell: Treatment C
ASP015K Formulation 2 with moderate-fat meal
|
oral
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Composite of pharmacokinetic parameters of ASP015K: C max, AUClast, and AUCinf
Tidsram: Up to Day 18
|
Up to Day 18
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Composite of pharmacokinetic parameters of ASP015K: tmax, apparent terminal elimination half-life (t1/2), apparent body clearance after oral dosing (CL/F), and apparent volume of distribution (Vz/F)
Tidsram: Up to Day 18
|
Up to Day 18
|
Composite of pharmacokinetic parameters of ASP015K metabolite H2: Cmax, AUClast, AUCinf, tmax and t1/2
Tidsram: Up to Day 18
|
Up to Day 18
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 015K-CL-PK19
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Astellas Pharma IncAvslutadPatienter med nedsatt njurfunktionJapan
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Astellas Pharma China, Inc.Avslutad
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Astellas Pharma IncAvslutadFriska ämnen | Farmakokinetik för ASP015KFörenta staterna
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Astellas Pharma IncAvslutadFriska ämnen | Farmakodynamik | Farmakokinetik för ASP015KFörenta staterna
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Astellas Pharma IncAvslutadFriska ämnen | Farmakokinetik för ASP015KFörenta staterna
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Astellas Pharma IncAvslutadArtrit, reumatoidJapan, Korea, Republiken av, Taiwan
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Astellas Pharma IncAvslutadFriska ämnen | Biotillgänglighet för ASP015K | Farmakokinetik för ASP015KFörenta staterna
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Astellas Pharma Global Development, Inc.AvslutadArtrit, reumatoidFörenta staterna, Polen, Tjeckien, Bulgarien, Ungern, Mexiko
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Astellas Pharma Global Development, Inc.Janssen Biotech, Inc.AvslutadFriska volontärer | Farmakokinetik för ASP015KFörenta staterna