- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02111317
A Study to Evaluate the Effect of Verapamil on the Pharmacokinetics of ASP015K in Healthy Adult Subjects
7. april 2014 oppdatert av: Astellas Pharma Global Development, Inc.
A Phase 1, Open-label, Single-Sequence, Crossover Drug Interaction Study to Evaluate the Effect of Verapamil on the Pharmacokinetics of ASP015K in Healthy Adult Subjects
The purpose of this study is to evaluate the effect of verapamil, a P-glycoprotein (P-gp) inhibitor, on the pharmacokinetics of ASP015K.
This study will also assess the safety and tolerability of ASP015K administered alone and also and in combination with verapamil.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Eligible subjects will be admitted to the clinical unit on day -1 and remain confined until day 15.
Studietype
Intervensjonell
Registrering (Faktiske)
24
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
California
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Glendale, California, Forente stater, 91206
- Parexel
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 55 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
- Subject must be capable of swallowing multiple tablets
- Subject agrees not to participate in another investigational study while on treatment
Exclusion Criteria:
- Subject has a known or suspected hypersensitivity to verapamil, ASP015K, or any components of the formulations used.
- Subject has any of the liver function tests above the upper limit of normal (ULN)
- 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, GI, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy
- Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory) infection, or fungal (noncutaneous) infection within 1 week prior to day -1.
- Subject has any clinically significant abnormality following physical examination, ECG, such as sick sinus syndrome, second- or third-degree atrioventricular block, or atrial flutter/atrial fibrillation, or clinical laboratory tests
- Subject has a mean pulse < 50 or > 90 beats per minute (bpm); mean systolic blood pressure (SBP) < 100 or > 140 mmHg; mean diastolic blood pressure (DBP) < 60 or > 90 mmHg (measurements taken in triplicate after subject has been resting in sitting position for 5 minutes)
- Subject has a mean QTcF interval of > 430 msec (for males) and > 450 msec (for females)
- Subject has used any prescribed or nonprescribed 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 (no more than 2 g per day)
- Subject has smoked or has used tobacco-containing products and nicotine or nicotine-containing products in the past 6 months
- 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
- Subject anticipates an inability to abstain from xanthine (e.g., caffeine), grapefruit, Seville 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
- Subject has used any inducer of metabolism (e.g., barbiturates, rifampin) in the past 3 months prior to day -1
- Subject has had any significant blood loss, donated 1 unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within past 7 days
- Subject has a positive test for hepatitis B surface antigen (HBsAg), anti-hepatitis A virus (Immunoglobulin [Ig] M), anti-hepatitis C virus (HCV), hepatitis B core antibody or anti-human immunodeficiency virus (HIV) type 1 or type 2
- Subject has a positive tuberculosis (TB) skin test, Quantiferon Gold® test or T-SPOT® test
- 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
- Subject has had major gastrointestinal (GI) surgery or has a medical condition, which may inhibit the absorption and/or metabolism of study drug
- 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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: ASP015K and verapamil
Single dose of ASP015K, then repeat dose of verapamil, then a second single dose of ASP015K while continuing verapamil
|
muntlig
oral
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Pharmacokinetics of ASP015K: Maximum concentration (Cmax)
Tidsramme: Days 1-4 and Days 12-15
|
Days 1-4 and Days 12-15
|
Pharmacokinetics of ASP015K: Area under the concentration-time curve (AUC) from time of dosing to the last quantifiable concentration (AUClast)
Tidsramme: Days 1-4 and Days 12-15
|
Days 1-4 and Days 12-15
|
Pharmacokinetics of ASP015K: AUC from the time of dosing extrapolated to time infinity (AUCinf)
Tidsramme: Days 1-4 and Days 12-15
|
Days 1-4 and Days 12-15
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Pharmacokinetic profile of ASP015K: time of maximum plasma concentration (tmax), terminal elimination half-life (t½), apparent total systemic clearance (CL/F), and apparent volume of distribution during the terminal elimination phase (Vz/F)
Tidsramme: Days 1-4 and Days 12-15
|
Days 1-4 and Days 12-15
|
Pharmacokinetic profile of ASP015K metabolites: Cmax, AUClast, AUCinf, tmax and t½
Tidsramme: Days 1-4 and Days 12-15
|
Days 1-4 and Days 12-15
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Studiestol: Global Clinical Pharmacology Lead, Astellas Pharma Global Development, Inc.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2013
Primær fullføring (Faktiske)
1. november 2013
Studiet fullført (Faktiske)
1. november 2013
Datoer for studieregistrering
Først innsendt
4. april 2014
Først innsendt som oppfylte QC-kriteriene
7. april 2014
Først lagt ut (Anslag)
11. april 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
11. april 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. april 2014
Sist bekreftet
1. april 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 015K-CL-PK04
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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Kliniske studier på ASP015K
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Astellas Pharma Global Development, Inc.FullførtFriske Frivillige | Farmakokinetikk til ASP015K | MateffektForente stater
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Astellas Pharma IncFullførtPasienter med nedsatt nyrefunksjonJapan
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Astellas Pharma IncFullførtSunne fag | Biotilgjengelighet av ASP015K | Farmakokinetikk til ASP015KForente stater
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Astellas Pharma IncFullførtSunne fag | Farmakokinetikk til ASP015KForente stater
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Astellas Pharma China, Inc.Fullført
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Astellas Pharma IncFullførtSunne fag | Farmakokinetikk til ASP015KForente stater
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Astellas Pharma IncFullførtSunne fag | Farmakodynamikk | Farmakokinetikk til ASP015KForente stater
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Astellas Pharma IncFullførtLeddgikt, revmatoidJapan, Korea, Republikken, Taiwan
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Astellas Pharma Global Development, Inc.FullførtLeddgikt, revmatoidForente stater, Polen, Tsjekkia, Bulgaria, Ungarn, Mexico
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Astellas Pharma IncFullførtSunne fag | Biotilgjengelighet av ASP015K | Farmakokinetikk til ASP015KForente stater