- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01959399
Drug-Drug Interaction Study Evaluating Effects of ASP015K on Rosuvastatin
8 oktober 2013 uppdaterad av: Astellas Pharma Global Development, Inc.
A Phase 1, Open-Label, Single-Sequence Drug Interaction Study to Evaluate the Effect of Multiple-Dose ASP015K on the Pharmacokinetics of Rosuvastatin in Healthy Adult Subjects
The purpose of this study will be to assess the effect of multiple-doses of ASP015K on the pharmacokinetics of rosuvastatin in healthy adult male and female subjects.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
24
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
California
-
Glendale, California, Förenta staterna, 91206
- PAREXEL - Early Phase 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:
- 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.
- Asian subject must be first generation Japanese born in Japan with both parents and four grandparents of Japanese descent and have resided outside of Japan for 5 years or less, or first generation Chinese born in China with both parents and four grandparents of Chinese descent and have resided outside of China for 5 years or less, or first generation Korean born in Korea with both parents and four grandparents of Korean descent and have resided outside of Korea for 5 years or less.
- Non-Asian subject is self-reported as White, Black or African American, and Hispanic or Latino.
- 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.
- 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 from screening and throughout the study period and for 90 days after final study drug administration.
- Subject agrees not to participate in another investigational study while on treatment.
- Subject must be capable of swallowing multiple tablets.
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 rosuvastatin, ASP015K, or any components of the formulations used.
- Subject has had a previous intolerance or adverse reaction to a statin therapy.
- 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 any history or evidence of any clinically significant cardiovascular, gastro intestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy, as judged by the Investigator or designee.
- Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to day -1.
- Subject has a mean pulse < 40 or > 90 beats per minute (bpm); mean systolic blood pressure (SBP) > 140 mmHg; mean diastolic blood pressure (DBP) > 90 mmHg (measurements taken in triplicate after subject has been resting in sitting position for at least 5 minutes at screening and day -1.
- 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) and 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 6 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).
- Subject has a positive test for alcohol, drugs of abuse, or cotinine at screening or day -1.
- Subject has used any inducer of liver metabolism (e.g. barbiturates, rifampin) in the 3 months prior to day -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.
- Subject has a positive serology test for hepatitis B surface antigen (HBsAg) (total), anti hepatitis A virus (Ig M), anti-hepatitis C virus, anti-hepatitis B core, or anti HIV type 1 or type 2 at screening.
- Subject has participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half-lives of the drug, whichever is longer, prior to screening.
- Subject has a positive tuberculosis (TB) skin test, Quantiferon Gold test or T-SPOT® test at screening.
- Subject has received any vaccine within 60 days prior to study drug administration.
- Subject has had major gastrointestinal surgery or has a medical condition which may inhibit the absorption and/or metabolism of study drug.
- Subject anticipates an inability to abstain from xanthine (e.g., caffeine), grapefruit, Seville blood oranges (including marmalade), star fruit, or any products containing these items from 72 hours prior to day -1 and throughout the duration of the study.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: ASP015K + rosuvastatin
|
oral tablet
oral tablet
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Pharmacokinetic (PK) parameter for rosuvastatin: AUClast
Tidsram: Days 1 and 10
|
Area under the curve to the last measurable time
|
Days 1 and 10
|
Pharmacokinetic parameter for rosuvastatin: AUCinf
Tidsram: Days 1 and 10
|
Area under the curve to the infinity
|
Days 1 and 10
|
Pharmacokinetic parameter for rosuvastatin: Cmax
Tidsram: Days 1 and 10
|
Maximum Concentration
|
Days 1 and 10
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Composite of pharmacokinetic parameters for rosuvastatin: time after dosing when Cmax occurs (tmax), apparent-terminal elimination half-life (t1/2), apparent volume of distribution (Vz/F), apparent plasma clearance (CL/F)
Tidsram: Days 1 and 10
|
Days 1 and 10
|
|
Composite of PK parameters for ASP015K: Area under the curve in the dosing interval (AUCtau), Maximum Concentration (Cmax), time after dosing when Cmax occurs (tmax), apparent volume of distribution (Vz/F), apparent plasma clearance at steady (CLss/F)
Tidsram: Days 9 and 10
|
Days 9 and 10
|
|
Pharmacokinetic parameter for ASP015K: Ctrough
Tidsram: Days 7-10
|
Plasma concentration immediately before the next administration of study drug
|
Days 7-10
|
Pharmacokinetic parameter for ASP015K metabolites: Ctrough
Tidsram: Days 7-10
|
Plasma concentration immediately before the next administration of study drug
|
Days 7-10
|
Composite of pharmacokinetic parameters for ASP015K metabolites: Area under the curve in the dosing interval (AUCtau), Maximum Concentration (Cmax), time after dosing when Cmax occurs (tmax)
Tidsram: Days 9 and 10
|
Days 9 and 10
|
|
Safety assessed adverse events, clinical laboratory evaluations, 12-lead ECG measurements, physical examination and vital sign measurements
Tidsram: Day 1-14
|
Day 1-14
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
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 juli 2013
Avslutad studie (Faktisk)
1 juli 2013
Studieregistreringsdatum
Först inskickad
8 oktober 2013
Först inskickad som uppfyllde QC-kriterierna
8 oktober 2013
Första postat (Uppskatta)
10 oktober 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
10 oktober 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 oktober 2013
Senast verifierad
1 oktober 2013
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Antimetaboliter
- Immunsuppressiva medel
- Immunologiska faktorer
- Antikolesteremiska medel
- Hypolipidemiska medel
- Lipidreglerande medel
- Hydroximetylglutaryl-CoA-reduktashämmare
- Rosuvastatin kalcium
- Peficitinib
Andra studie-ID-nummer
- 015K-CL-PK26
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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Kliniska prövningar på ASP015K
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Astellas Pharma Global Development, Inc.AvslutadFriska volontärer | Farmakokinetik för ASP015K | Mat effektFörenta staterna
-
Astellas Pharma IncAvslutadPatienter med nedsatt njurfunktionJapan
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Astellas Pharma IncAvslutadFriska ämnen | Biotillgänglighet för ASP015K | Farmakokinetik för ASP015KFörenta staterna
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Astellas Pharma IncAvslutadFriska ämnen | Farmakokinetik för ASP015KFörenta staterna
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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 IncAvslutadArtrit, reumatoidJapan, Korea, Republiken av, Taiwan
-
Astellas Pharma Global Development, Inc.AvslutadArtrit, reumatoidFörenta staterna, Polen, Tjeckien, Bulgarien, Ungern, Mexiko
-
Astellas Pharma IncAvslutadFriska ämnen | Biotillgänglighet för ASP015K | Farmakokinetik för ASP015KFörenta staterna