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A Drug-drug Interaction Study of SHR2150 on Healthy Chinese Volunteers

17. december 2021 opdateret af: Jiangsu HengRui Medicine Co., Ltd.

A Single-centre, Single-arm, Open-label and Fixed-sequence Drug-drug Interaction Study to Evaluate the Effect of Efavirenz on the Pharmacokinetics of SHR2150 in Healthy Chinese Subjects

The study is a single-centre, open-label, fixed-sequence, self-controlled clinical trial. It is planned to enroll 20 healthy adult subjects.

Subjects will take SHR2150 on Day 1 and Day 21, and take efavirenz from Day 7 to Day 26.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

20

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

    • Liaoning
      • Shenyang, Liaoning, Kina, 110067
        • The People's Hospital of Liaoning Province

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:

  1. The subject can communicate well with the researcher, understand and comply with the requirements of this study, and understand and sign the informed consent;
  2. Healthy subjects aged 18 ~ 45 (including the boundary value), male and female;
  3. Male body weight ≥ 50 kg, female body weight ≥ 45 kg, body mass index (BMI) within the range of 18 ~ 26 kg/m2 (including the boundary value) (BMI= weight (kg)/height 2 (m2));
  4. The physical examination, vital signs, laboratory examination, 12-lead electrocardiogram, abdominal B-ultrasound, and chest radiograph are normal or have no clinical significance;
  5. The subjects with reproduction ability must agree to take effective contraceptive measures after signing the informed consent form and within 7 months (for female) or 4 months (for male) until the last medication.

Exclusion Criteria:

  1. Anyone who has suffered from any clinical serious disease such as the circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry and metabolic abnormalities, or any other disease which can affect the study results;
  2. Those who have undergone surgery within 3 months before the trial, or plan to perform surgery during the study period;
  3. Those whose 12-lead ECG is abnormal with clinically significant or ECG QT interval (QTcF) ≥ 450 ms (for male) or > 460 ms (for female) or < 300 ms;
  4. Those who donated blood or suffered heavy blood loss (≥400 mL), received blood transfusions, or used blood products within 3 months before enrollment;
  5. Have a history of allergies to drugs, food or other substances;
  6. Those who have used soft drugs or hard drugs; or those with positive results in urine drug abuse screening;
  7. Those who have participated in any clinical trials and have taken study drugs within 3 months before the first administration;
  8. Those who have taken any medicine within 1 month before the first administration (including prescription medicines, non-prescription medicines, Chinese herbal medicines, vitamins, calcium tablets and other food supplements), especially the drugs which have any effect on CYP3A4;
  9. Regular drinkers within 3 months before the test, that is, drinking more than 15 g of alcohol per day (15 g alcohol = 450 mL of beer, or 50 mL of spirits, or 150 mL of wine), and any alcohol-containing products cannot be stopped during the study;
  10. Hepatitis B virus surface antigen is positive, or hepatitis C virus antibody is positive, or treponema pallidum antibody is positive, or human immunodeficiency virus antibody is positive;
  11. Women with pregnancy or within lactation period.

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: Treatment group
SHR2150+ efavirenz
SHR2150 tablet single dose, Efavirenz single dose.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Tmax
Tidsramme: from Day 1 to Day 7 after the first dose and from Day 21 to Day 27 after the second dose
Time to maximum observed serum concentration (Tmax) for SHR2150 after Single dose
from Day 1 to Day 7 after the first dose and from Day 21 to Day 27 after the second dose
Cmax
Tidsramme: from Day 1 to Day 7 after the first dose and from Day 21 to Day 27 after the second dose
Maximum observed serum concentration (Cmax) for SHR2150 after Single dose
from Day 1 to Day 7 after the first dose and from Day 21 to Day 27 after the second dose
AUC0-t
Tidsramme: from Day 1 to Day 7 after the first dose and from Day 21 to Day 27 after the second dose
Area under the plasma concentration versus time curve (AUC0-t) for SHR2150 after Single dose
from Day 1 to Day 7 after the first dose and from Day 21 to Day 27 after the second dose
AUC0-inf
Tidsramme: from Day 1 to Day 7 after the first dose and from Day 21 to Day 27 after the second dose
Area under the plasma concentration versus time curve (AUC0-inf ) for SHR2150 after Single dose
from Day 1 to Day 7 after the first dose and from Day 21 to Day 27 after the second dose
T1/2
Tidsramme: from Day 1 to Day 7 after the first dose and from Day 21 to Day 27 after the second dose
Time to elimination half-life (T1/2) for for SHR2150 after Single dose
from Day 1 to Day 7 after the first dose and from Day 21 to Day 27 after the second dose

Sekundære resultatmål

Resultatmål
Tidsramme
Number of subjects with adverse events and the severity of adverse events
Tidsramme: from Day 1 to Day 37 after the first dose
from Day 1 to Day 37 after the first dose

Samarbejdspartnere og efterforskere

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

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)

13. december 2021

Primær færdiggørelse (Forventet)

15. januar 2022

Studieafslutning (Forventet)

22. januar 2022

Datoer for studieregistrering

Først indsendt

19. november 2021

Først indsendt, der opfyldte QC-kriterier

19. november 2021

Først opslået (Faktiske)

2. december 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. december 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. december 2021

Sidst verificeret

1. december 2021

Mere information

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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