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Pharmacokinetic (PK) Profiles of Tenofovir Disoproxil Fumarate (TDF) 300 mg in Healthy Chinese Subjects (PK of TDF)

13. juni 2017 opdateret af: GlaxoSmithKline

An Open-label Single and Repeat Dose Study to Investigate the Pharmacokinetic Profiles of Tenofovir Disoproxil Fumarate 300 mg in Healthy Chinese Subjects

This study will evaluate the pharmacokinetic profile of tenofovir disoproxil fumarate (TDF) 300 mg in Chinese subjects to support the registration of this compound in the People's Republic of China. This will be an open-label, single group, single and repeat dose study without placebo in healthy male and female subjects. Pharmacokinetic sampling to enable measurement of plasma concentrations of tenofovir will be conducted over a 60-h period after the single dose and at steady state. The duration of the study will be approximately 7 weeks from screening to follow-up.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This will be an open-label, single group, single and repeat dose study with no placebo control in healthy Chinese subjects conducted at a single centre. The study will include a screening visit, single and repeat dose sessions and a follow-up contact.

The screening visit will be conducted up to 28 days prior to the first dose of treatment period 1. Screening assessments will occur as indicated in the Time and Events Table.

Subjects who meet the inclusion/exclusion criteria will be admitted to the study centre on Day -1 to undergo baseline procedures before the single dose session. Study medication will be administered the following morning (Day 1) for the single dose phase. Subjects will be required to fast for at least 8 h (overnight) prior to dosing until 4 h after dosing. Pharmacokinetic samples will be taken until Day 3.

The repeat dose session will begin on Day 4. Subjects will receive a once daily dose of TDF 300 mg in a fasted state each morning for 7 days. Subjects will be required to fast for at least 8 h (overnight) prior to dosing on Day 8 and Day 9, and for at least 8 h (overnight) prior to dosing until 4 h after dosing on Day 10. A trough pharmacokinetic sample will be collected before dosing on Day 8, Day 9 and a series of samples will be taken from Day 10 to Day 12.

Subjects will remain in-house from the evening before dosing (Day -1) until after the final pharmacokinetic sample has been collected on Day 12 and the final safety assessment completed on Day 13. Then subjects will be discharged from the study centre at the Investigator's discretion.

Subjects completing the dosing sessions will not be required to visit the study centre for a follow-up visit, unless the Investigator determines that it is necessary for safety or other reasons. All subjects will receive a follow-up contact by telephone or visit 7 days after the last dosing to collect any information on concomitant medication taken and AEs experienced since the last visit.

The total duration of each subject's participation, from screening to follow-up contact, will be approximately 7 weeks.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

14

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
      • Shanghai, Kina, 200030
        • GSK Investigational Site

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 45 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Healthy, as determined by a responsible and experienced physician
  • Male or female between 18 and 45 years of age
  • Body weight >50 kg (110 lbs) for males or >45 kg (100 lbs) for females, and body mass index (BMI) between 19.0 and 24.0 kg/m2

Exclusion Criteria:

  • Positive result for hepatitis B, hepatitis C or HIV at screening
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities
  • Positive urine drug screen and breath alcohol test at screening or prior to dosing
  • Lactating females

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: TDF tablets
Tenofovir disoproxil fumarate tablets
Medicin: TDF tablets
White, almond-shaped, film-coated tablets, one side with the markings "GILEAD" and "4331"

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC(0-t))
Tidsramme: up to 60 hours after single dose
AUC(0-t) of single dose
up to 60 hours after single dose
area under the concentration-time curve during steady state (AUC(0-τ))
Tidsramme: up to 60 hours after repeat dose
AUC(0-τ) during steady state
up to 60 hours after repeat dose

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
adverse events (AEs)
Tidsramme: up to 20 days, from the first dose until the follow-up contact
AEs accur during the study
up to 20 days, from the first dose until the follow-up contact
vital signs
Tidsramme: day 1 pre-dose, day 2, day 3, day 10 pre-dose, day 11, day 12 and day 13 prior to discharge from hospital
blood pressure, pulse rate, respiratory rate and temperature
day 1 pre-dose, day 2, day 3, day 10 pre-dose, day 11, day 12 and day 13 prior to discharge from hospital
lab assessment
Tidsramme: day 13, prior to discharge from hospital
Haematology, Clinical Chemistry and Routine Urinalysis
day 13, prior to discharge from hospital
12-lead electrocardiogram (ECG) parameters
Tidsramme: day 13, prior to discharge from hospital
the heart rate and measures PR, QRS, QT and QTc intervals. All ECGs must be evaluated for safety by a qualified physician.
day 13, prior to discharge from hospital

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

GlaxoSmithKline

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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 (Faktiske)

5. december 2011

Primær færdiggørelse (Faktiske)

30. december 2011

Studieafslutning (Faktiske)

30. december 2011

Datoer for studieregistrering

Først indsendt

17. november 2011

Først indsendt, der opfyldte QC-kriterier

23. november 2011

Først opslået (Skøn)

29. november 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. juni 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juni 2017

Sidst verificeret

1. juni 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 115515

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 .

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Kliniske forsøg med TDF tablets

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner