- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02245451
Study of Tipranavir and Ritonavir on the Pharmacokinetic Characteristics of Methadone Administered in Healthy Volunteers
18. september 2014 oppdatert av: Boehringer Ingelheim
A Single-centre, Open-label Study of Multiple Doses of Tipranavir 500 mg and Ritonavir 200 mg (Twice Daily) on the Pharmacokinetic Characteristics of Methadone Administered as a Single Dose in Healthy Volunteers
The primary objective of this study is to characterise the effects of tipranavir 500 mg and ritonavir 200 mg (TPV/r; given twice daily) at steady-state on the pharmacokinetics of methadone administered as a single dose in healthy adult volunteers
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
15
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 60 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Male or female healthy volunteers aged at least 18 to 60 years.
- Clinically normal medical history.
- Clinically normal findings on physical examination.
- Clinically normal laboratory values.
- A Body Mass Index >18.5 and <30 kg/m2.
- Able to swallow large capsules without difficulty.
- Capable of comprehending and communicating effectively with the investigator and staff and of providing written informed consent in accordance with ethics committee and regulatory guidelines.
- Willing to stay in the study centre for the duration of the study.
- Willing to abstain from ingesting substances during the study which may alter plasma study drug levels by interaction with the cytochrome P450 system.
- Willing to abstain from alcohol for 48 hours prior to Visit 1 and for the duration of the study. In addition, Cabernet Sauvignon must not have been ingested within 15 days prior to Visit 1.
- Willing to abstain from ingesting grapefruit and grapefruit juice for 15 days before Visit 1 and for the duration of the study.
- Willing to abstain from ingesting Seville oranges, strawberries or strawberry extract, garlic supplements, St. John's Wort, Milk Thistle, or methylxanthine-containing drinks or food (coffee, tea, cola, energy drinks, chocolate, etc) for 72 hours before the pharmacokinetic sampling days.
- Willing to abstain from use of tobacco products for the duration of the study.
- Urine drug screen negative for illegal non-prescription drugs.
- Negative HIV serology.
- Negative for Hepatitis B surface antigen and Hepatitis C
Exclusion Criteria:
- Any clinically significant disease. (A significant disease was defined as a disease which in the opinion of the investigator may either have put the subject at risk because of participation in the study or a disease which may have influenced the results of the study or the subject's ability to participate in the study.)
- Clinically significant abnormal baseline haematology, blood chemistry or urinalysis findings.
- Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), cholesterol, triglyceride or glucose greater than the upper limit of normal at Visit 1.
- Treatment with prohibited medications in the thirty days before the study or during the study or ingestion of drugs of abuse.
- Treatment with any investigational drug within 90 days of the first dose of study medication.
- Inability to adhere to the requirements of the protocol (including active substance abuse) as assessed by the investigator.
- Prior tipranavir use.
- Ingestion of any known enzyme altering drug (such as phenothiazines, cimetidine, barbiturates, ketoconazole, fluconazole, clarithromycin, rifampin, steroids, and herbal medications) for thirty days prior to Visit 1.
- Ingestion of grapefruit, grapefruit juice, and Cabernet Sauvignon within fifteen days prior to Visit 1.
- Ingestion of Seville oranges, strawberries or strawberry extract, garlic supplements, St. John's Wort, Milk Thistle, or methylxanthine-containing drinks or food (coffee, tea, cola, energy drinks, chocolate, etc) within 72 hours of pharmacokinetics sampling days.
- Treatment with prescription medicines within thirty days prior to Visit 1.
- History of gastrointestinal, hepatic, or renal disorders within 60 days prior to Visit 1.
- Any history of alcohol or drug abuse.
- Current use of cigarettes defined as greater than 10 cigarettes per day or rolling/pipe tobacco equivalent.
- Blood or plasma donations within 90 days prior to Visit 1
- Subjects with a seated systolic blood pressure either <100 mm Hg or >150 mm Hg; resting heart rate either <50 beats/min or >100 beats/min.
- Subjects with a history of any illness or allergy that, in the opinion of the investigator, might have confounded the results of the study or posed additional risk in administering tipranavir, ritonavir or methadone to the subject.
- Subjects who had an acute illness within two weeks prior to Visit 1.
- Subjects who were currently taking any over-the-counter drug within fourteen days prior to Visit 1 or who were currently taking any prescription drug.
- Hypersensitivity to tipranavir, ritonavir, or methadone.
- Female subjects who are of reproductive potential and who were pregnant, breastfeeding, had a positive serum B-HCG at Visit 1 or 2, had not been using a barrier contraceptive method for at least three months prior to Study Day 1 or were not willing to use a reliable method of double-barrier contraception (such as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam) during the study and for thirty days after completion or termination of the study.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: TPV/r with methadone
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Area under the concentration-time curve for 0 to 24 hours (AUC0-24h) of methadone
Tidsramme: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
Maximum concentration (Cmax)
Tidsramme: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
Concentration at 6 hours (C6h) of methadone
Tidsramme: 6 hours after drug administration
|
6 hours after drug administration
|
Area under the concentration-time curve for 0 to 12 hours (AUC0-12h) of tipranavir and ritonavir
Tidsramme: up to 12 hours after drug administration
|
up to 12 hours after drug administration
|
concentration at 12 hours (C12h) of tipranavir and ritonavir
Tidsramme: 12 hours after drug administration
|
12 hours after drug administration
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
mean residence time (MRT)
Tidsramme: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
apparent terminal half-life (t½)
Tidsramme: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
time to maximum concentration (Tmax)
Tidsramme: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
oral clearance (CL/F)
Tidsramme: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
apparent volume of distribution during the terminal elimination phase divided by the bioavailability factor (Vz/F)
Tidsramme: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
Number of patients with abnormal findings in physical examination
Tidsramme: Up to day 17 after first drug administration
|
Up to day 17 after first drug administration
|
Number of patients with clinically significant changes in vital signs
Tidsramme: Up to day 17 after first drug administration
|
Up to day 17 after first drug administration
|
Number of patients with abnormal changes in clinical laboratory parameters
Tidsramme: Up to day 17 after first drug administration
|
Up to day 17 after first drug administration
|
Number of participants with adverse events
Tidsramme: Up to day 17 after first drug administration
|
Up to day 17 after first drug administration
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
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. januar 2005
Primær fullføring (Faktiske)
1. februar 2005
Datoer for studieregistrering
Først innsendt
18. september 2014
Først innsendt som oppfylte QC-kriteriene
18. september 2014
Først lagt ut (Anslag)
19. september 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
19. september 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. september 2014
Sist bekreftet
1. september 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Sentralnervesystemdepressiva
- Agenter fra det perifere nervesystemet
- Antivirale midler
- Enzymhemmere
- Anti-HIV-midler
- Antiretrovirale midler
- Analgetika
- Sensoriske systemagenter
- Proteasehemmere
- Analgetika, opioid
- Narkotika
- Cytokrom P-450 CYP3A-hemmere
- Cytokrom P-450 enzymhemmere
- Luftveismidler
- HIV-proteasehemmere
- Virale proteasehemmere
- Hostestillende midler
- Ritonavir
- Tipranavir
- Metadon
Andre studie-ID-numre
- 1182.26
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 Sunn
-
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 Tipranavir
-
Boehringer IngelheimFullført
-
Boehringer IngelheimFullført
-
Boehringer IngelheimFullførtHIV-infeksjonerForente stater, Puerto Rico
-
Boehringer IngelheimFullført
-
Boehringer IngelheimAvsluttet
-
Boehringer IngelheimGodkjent for markedsføringHIV-infeksjonerBelgia, Brasil, Canada, Danmark, El Salvador, Hellas, Italia, Portugal, Spania
-
Boehringer IngelheimFullførtHIV-infeksjonerForente stater, Argentina, Australia, Østerrike, Belgia, Brasil, Canada, Danmark, Frankrike, Tyskland, Hellas, Italia, Mexico, Nederland, Portugal, Spania, Sveits, Storbritannia