- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02242734
Pharmacokinetics and Metabolism of Hydrocodone Bitartrate Controlled-Release (HC-CR) in Subjects With Hepatic Impairment
8. november 2022 oppdatert av: Zogenix, Inc.
Evaluation of the Effect of Hepatic Impairment on the Pharmacokinetics and Metabolism of Hydrocodone and Its Metabolites Following Administration of Hydrocodone Bitartrate Extended-Release (HC-ER) 20mg Capsules
Determine the influence of hepatic impairment on the pharmacokinetics and metabolism of Hydrocodone Bitartrate Extended-Release (HC-ER) 20 mg capsules
Studieoversikt
Detaljert beskrivelse
Pharmacokinetics and relative bioavailability of hydrocodone and its metabolites under fasted conditions
Studietype
Intervensjonell
Registrering (Faktiske)
30
Fase
- Fase 1
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 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- All hepatically-impaired subjects must have meet all of the following inclusion criteria to be enrolled into the study:
- Male or non-pregnant, non-lactating females. Subjects were aged 18-80 years, inclusive.
- Subjects must have been a clinical diagnosis of chronic hepatic impairment for duration of at least 6 months classified as mild or moderate as per Child-Pugh classification.
- Hepatic insufficiency was stable with no acute episodes of illness within the previous 2 months due to deterioration of hepatic function due to any etiology.
- Female subjects of childbearing potential including those who had a tubal ligation surgery but excluded those who did not have a menstrual period for a minimum of 2 years, had a negative pregnancy test at the Screening and Day -1 visits, and consented to use a medically-acceptable method of contraception throughout the entire study period and for 1 week after the study completed. Medically acceptable methods of contraception included were not limited to abstinence, birth control pills or patches, vaginal rings, diaphragm with vaginal spermicide, Intrauterine Device, and progestin implant or injection (used consistently for 3 months prior to study dosing).
- Subjects voluntarily provided written informed consent.
Subjects, in the Investigator's opinion, were able to complete study procedures
- All healthy control subjects must have met all hepatic subject inclusion criteria as outlined above with the exception of Inclusion Criteria 3 & 4 above which should be substituted with the following to be enrolled into the study:
- Must have been matched by age (±10 years) and Body Mass Index (BMI) (± 10% of BMI) with some consideration for race and gender to subjects with hepatic impairment.
- Were medically healthy with no clinically significant abnormalities in their laboratory profile as deemed by the Investigator.
Exclusion Criteria:
- Women who were pregnant or breastfeeding
- Any clinically significant condition that would, in the opinion of the Investigator, preclude study participation
- Uncontrolled blood pressure, i.e., subject has a sitting systolic blood pressure 180 mmHg or 90 mmHg, and/or a sitting diastolic blood pressure 120 mmHg or 50 mmHg at Screening.
- Body Mass Index (BMI) >40 kg/m2.
- Known allergy or hypersensitivity to hydrocodone, or other opioids.
- Had taken any investigational drug within 30 days prior to the Day 1 Visit or currently enrolled in another investigational drug study.
- Had used a monoamine oxidase inhibitor within 14 days prior to Day 1.
- Been taking opioids during the 30 days prior to Day 1 or needing to take opioids during the study period
- Positive for human immunodeficiency virus (HIV). Healthy control subjects must not have been hepatitis C virus (HCV) positive, hepatically-impaired subjects could be HCV positive but should not have been receiving treatment.
- History of any illicit substance abuse in the past 2 years or any history of opioid abuse. Subjects should not have been current abusers of alcohol and must have had a negative serum alcohol level at Screening and Day -1.
- Positive quantitative urine drug screen for illicit drugs, or non-prescribed controlled substances at Screening.
- Had made a plasma donation within 7 days prior to Day 1.
- Had made any significant donation or loss of blood within 56 days prior to Day 1.
- Had taken CYP2D6 and/or CYP3A4 inhibitors within 7 days prior to Day 1 and/or CYP2D6 and/or CYP3A4 inducers within 21 days prior to Day 1.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Mild Hepatic Impairment
20 mg HC-ER
|
1-72 timer
Andre navn:
|
Eksperimentell: Moderate Hepatic Impairment
20 mg HC-ER
|
1-72 timer
Andre navn:
|
Eksperimentell: No Hepatic Impairment
20 mg HC-ER
|
1-72 timer
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Farmakokinetisk profil av hydrokodon og dets metabolitter på 20 mg HC-ER
Tidsramme: Dag 1-3
|
PK-parametere inkludert Cmax, Tmax, , AUC 0-t, AUC 0-inf, T1/2 og Kel
|
Dag 1-3
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Kenneth Lasseter, MD, Zogenix, 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. februar 2011
Primær fullføring (Faktiske)
1. mai 2011
Studiet fullført (Faktiske)
1. mai 2011
Datoer for studieregistrering
Først innsendt
19. august 2014
Først innsendt som oppfylte QC-kriteriene
15. september 2014
Først lagt ut (Anslag)
17. september 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. november 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. november 2022
Sist bekreftet
1. september 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ZX002-1001
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 Nedsatt leverfunksjon
-
Johns Hopkins UniversityNational Institute on Aging (NIA)RekrutteringSøvnforstyrrelser | AMCI - Amnestic Mild Cognitive ImpairmentForente stater
Kliniske studier på 20 mg HC-ER
-
Zogenix, Inc.Fullført
-
Zogenix, Inc.Fullført
-
HiberCell, Inc.CovanceFullførtNyrecellekarsinom | Magekreft | Metastatisk brystkreft | Småcellet lungekreft | Andre solide svulsterForente stater
-
Vanda PharmaceuticalsFullførtIkke-24-timers søvn-våkne lidelse
-
Onconic Therapeutics Inc.Fullført
-
HiberCell, Inc.CovanceAvsluttetKlarcellet nyrecellekarsinom | Ikke småcellet lungekreft | Plateepitelkarsinom i hode og nakke | Tykktarmskreft | Overgangscellekarsinom i blæren | Andre solide svulsterForente stater
-
Hinova Pharmaceuticals USA, Inc.Aktiv, ikke rekrutterendeKastrasjonsresistent prostatakreft | Prostatakreft MetastatiskTyskland, Spania, Danmark, Frankrike, Storbritannia, Den russiske føderasjonen, Polen, Australia, Italia, Nederland, Forente stater, Finland, Canada, Østerrike
-
Peking Union Medical College HospitalHar ikke rekruttert ennå