- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02111317
A Study to Evaluate the Effect of Verapamil on the Pharmacokinetics of ASP015K in Healthy Adult Subjects
7. april 2014 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Eligible subjects will be admitted to the clinical unit on day -1 and remain confined until day 15.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
24
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
-
Glendale, California, Forenede Stater, 91206
- Parexel
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 55 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: ASP015K and verapamil
Single dose of ASP015K, then repeat dose of verapamil, then a second single dose of ASP015K while continuing verapamil
|
mundtlig
oral
Andre navne:
|
Hvad måler undersøgelsen?
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Studiestol: Global Clinical Pharmacology Lead, Astellas Pharma Global Development, Inc.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2013
Primær færdiggørelse (Faktiske)
1. november 2013
Studieafslutning (Faktiske)
1. november 2013
Datoer for studieregistrering
Først indsendt
4. april 2014
Først indsendt, der opfyldte QC-kriterier
7. april 2014
Først opslået (Skøn)
11. april 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
11. april 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. april 2014
Sidst verificeret
1. april 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 015K-CL-PK04
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med ASP015K
-
Astellas Pharma Global Development, Inc.AfsluttetSunde frivillige | Farmakokinetik af ASP015K | Mad effektForenede Stater
-
Astellas Pharma IncAfsluttetPatienter med nedsat nyrefunktionJapan
-
Astellas Pharma China, Inc.Afsluttet
-
Astellas Pharma IncAfsluttetSunde emner | Farmakokinetik af ASP015KForenede Stater
-
Astellas Pharma IncAfsluttetSunde emner | Farmakodynamik | Farmakokinetik af ASP015KForenede Stater
-
Astellas Pharma IncAfsluttetSunde emner | Biotilgængelighed af ASP015K | Farmakokinetik af ASP015KForenede Stater
-
Astellas Pharma IncAfsluttetSunde emner | Farmakokinetik af ASP015KForenede Stater
-
Astellas Pharma IncAfsluttetPatienter med nedsat leverfunktionJapan
-
Astellas Pharma IncAfsluttetSunde emner | Biotilgængelighed af ASP015K | Farmakokinetik af ASP015KForenede Stater
-
Astellas Pharma Global Development, Inc.Janssen Biotech, Inc.AfsluttetGigt, reumatoidForenede Stater, Belgien, Bulgarien, Colombia, Tjekkiet, Ungarn, Mexico, Polen