- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01565720
Study of the Effect of Repeat Doses of Isavuconazole on Cardiac Repolarization
5. juli 2012 oppdatert av: Astellas Pharma Global Development, Inc.
A Phase 1, Randomized, Double Blind, Placebo and Active Controlled, Parallel Study to Evaluate the Effect of Repeat Doses of Isavuconazole on Cardiac Repolarization in Healthy Adult Subjects
This study is designed to evaluate repeat doses of isavuconazole on cardiac repolarization in healthy adult subjects.
Eligible subjects will be randomized to one of four treatment groups and be confined for 17 days including pre-dosing days.
Moxifloxacin will be given as an active control on the last dosing day to healthy subjects in one of the four groups.
All treatments, except the moxifloxacin dose, are double-blinded (neither the subject nor the study doctor will know the treatment assignment).
Subjects will undergo continuous ECGs on three study days.
ECGs, vital signs, blood draws will be obtained throughout the study for safety and to assess the amount of study drug in body.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
161
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
-
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 must weigh at least 45 kg and have a body mass index of 18-30 kg/m2
- If female, the subject agrees to sexual abstinence, is surgically sterile, postmenopausal or using a medically acceptable double-barrier method to prevent pregnancy and agrees to continue using this method during the study and until two weeks after the end of the study. Female subjects must not be lactating or pregnant as documented by a negative pregnancy test at Screening and Day -3
- If male, the 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 during the study and until two weeks after the end of the study
- The subject's clinical laboratory test results at Screening and Day -3 are within normal limits or any abnormal results are considered not to be clinically significant
- The subject has a sitting systolic blood pressure between 90 and 140 mmHg, inclusive and diastolic blood pressure between 50 and 90 mmHg, inclusive at Screening and Day -3
- The subject has good venous access
Exclusion Criteria:
- The subject has a previous history of any clinically significant gastro-intestinal, neurological, renal, hepatic, pulmonary, metabolic, cardio-vascular, psychiatric, endocrine, hematological disorder or disease, malignancy excluding non-melanoma skin cancer or any other medical condition that would preclude participation in the study
- The subject has evidence of any cardiac conduction abnormalities
- The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia, torsade de pointes, structural heart disease, or family history of Long QT syndrome or Short QT syndrome
- The subject has potassium, calcium, or magnesium levels that are below the clinical laboratory's lower limit of normal
- The subject has a history of consuming more than 14 units of alcoholic beverages per week, has a history of alcohol abuse within the past 2 years prior to Screening, or has a positive screen for alcohol at Screening or Day 3. (NOTE: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits/hard liquor.)
- The subject has a history of drug, chemical, or substance abuse within the past 2 years prior to Screening or has a positive test at Screening or Day -3 for drugs of abuse
- The subject has used tobacco-containing products or nicotine-containing products within 3 months prior to Screening
- The subject has had treatment with prescription drugs or complementary and alternative medicines within 14 days prior to Screening, or over-the-counter medication within 7 days prior to Screening (with the exception of acetaminophen up to 2 grams/day)
- The subject anticipates an inability to abstain from caffeine or alcohol for 48 hours prior to Day -3 and throughout the duration of the study
- The subject anticipates an inability to abstain from grapefruit, Seville oranges, star fruit, or any products containing these items from 72 hours prior to Day -3 and throughout the duration of the study
- The subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 7 days prior to Day -3
- The subject has been vaccinated within the last 30 days prior to Screening
- The subject has a positive test for hepatitis C antibody or hepatitis B surface antigen at Screening or a known history of human immunodeficiency virus
- The subject has known or suspected hypersensitivity to any of the quinolone antibiotics or a history of tendonitis and/or liver function abnormality related to quinolone antibiotic treatment
- The subject has a known or suspected hypersensitivity to isavuconazole, the azole class of compounds, or any components of the study drugs
- The subject has received an experimental agent within 30 days or five half-lives, whichever is longer, prior to Screening
- The subject has had any significant blood loss, donated one or more units (450 mL) of blood or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to Day -3
- The subject has any other condition, which in the opinion of the investigator, precludes the subject's participation in the trial
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Group 1
Isavuconazole low dose 3 times per day (TID) for 2 days followed by isavuconazole low dose once a day (QD) for 11 days
|
muntlig
Andre navn:
|
Eksperimentell: Group 2
Isavuconazole low dose 3 times per day (TID) for 2 days followed by isavuconazole high dose once a day (QD) for 11 days
|
muntlig
Andre navn:
|
Placebo komparator: Group 3
Placebo 3 times a day (TID) for 2 days followed by placebo once a day (QD) for 11 days
|
muntlig
|
Aktiv komparator: Group 4
Placebo 3 times a day (TID) for 2 days followed by placebo once a day (QD) for 10 days and then moxifloxacin on Day 13
|
muntlig
oral
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change from baseline in QT interval corrected for heart rate using Fridericia's correction (QTcF)
Tidsramme: Baseline and Day 13
|
Baseline and Day 13
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change from baseline in Electrocardiogram (ECG) variables: QT, PR, RR intervals, QRS, and Heart Rate
Tidsramme: Baseline and Day 13
|
Baseline and Day 13
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
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. mars 2012
Primær fullføring (Faktiske)
1. juni 2012
Studiet fullført (Faktiske)
1. juni 2012
Datoer for studieregistrering
Først innsendt
27. mars 2012
Først innsendt som oppfylte QC-kriteriene
27. mars 2012
Først lagt ut (Anslag)
29. mars 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
9. juli 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. juli 2012
Sist bekreftet
1. juli 2012
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 9766-CL-0017
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. .
Kliniske studier på Friske Frivillige
-
Universidade do PortoFundação para a Ciência e a TecnologiaRekrutteringHealthy People-programmerPortugal
-
VA Office of Research and DevelopmentFullført
-
Universidad Católica del MauleFullført
-
University of MiamiJames and Esther King Biomedical Research ProgramAvsluttetHealthy Lifetime Ikke-røykereForente stater
-
Fundació Institut de Recerca de l'Hospital de la...FullførtHealthy People-programmerSpania
-
University of LeicesterNational Institute for Health Research, United KingdomFullførtPasienter med hjertesvikt og bevart ejeksjonsfraksjon - HFpEF | Pasienter med hjertesvikt med redusert ejeksjonsfraksjon - HFrEF | Healthy Controls Group - alders- og kjønnsmatchet
-
University Hospital, GrenobleUniversity Hospital, Clermont-Ferrand; Grenoble Institut des NeurosciencesAvsluttetParkinsons sykdom | Healthy Controls Group - alders- og kjønnsmatchetFrankrike
Kliniske studier på Placebo
-
SamA Pharmaceutical Co., LtdUkjentAkutt bronkitt | Akutt øvre luftveisinfeksjonKorea, Republikken
-
National Institute on Drug Abuse (NIDA)FullførtCannabisbrukForente stater
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyFullførtMannlige personer med type II diabetes (T2DM)Tyskland
-
Heptares Therapeutics LimitedFullførtFarmakokinetikk | SikkerhetsproblemerStorbritannia
-
Texas A&M UniversityNutraboltFullførtGlucose and Insulin Response
-
Regado Biosciences, Inc.FullførtFrivillig friskForente stater
-
Longeveron Inc.AvsluttetHypoplastisk venstre hjertesyndromForente stater
-
ItalfarmacoFullførtBecker muskeldystrofiNederland, Italia
-
Instituto de Investigación Hospital Universitario...Creaciones Aromáticas Industriales, S.A. (CARINSA)Fullført