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The Tolerability and Pharmacokinetics Study of HEC74647PA Capsule in Healthy Adult Subjects

17. marts 2020 opdateret af: Sunshine Lake Pharma Co., Ltd.

A Phase I, Single-center, Randomized，Double-blind, Placebo-controlled, Single & Multiple Ascending Dose Study to Assess the Tolerability and Pharmacokinetics of HEC74647PA Capsule in Healthy Adult Subjects

The Tolerability and Pharmacokinetics Study of HEC74647PA Capsule in Healthy Adult Subjects

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single & Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of HEC74647PA Capsule in Healthy Adult Subjects.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

105

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Kina
    • Jilin
      • Changchun, Jilin, Kina, 130021
        • The First Hospital of Jilin University

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:

  • Able to comprehend and sign the ICF voluntarily prior to initiate the study;
  • Able to complete the study according to the protocol;
  • Between 18 and 45 years of age, inclusive, male subject should be no fertility needs;
  • Body weight of male and female subject should be ≥50 kg and ≥45 kg respectively; Body Mass Index (BMI) is between 18 and 28 kg/m2, inclusive;
  • Physical examination and vital signs without clinically significant abnormalities.

Exclusion Criteria:

  • Smokers, who smoke more than 5 cigarettes/day within 3 months before the study;
  • Drink frequently, namely alcohol consumption are 14 units per week (1 unit = 285 mL of beer, or 25 mL of strong wine, or 100 mL of grape wine);
  • Donated blood or massive blood loss within 3 months before screening (>450 mL）;
  • Have any disease that increases the risk of bleeding, such as acne, acute gastritis or stomach and duodenal ulcers;
  • Have taken any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 1 month prior to screening;
  • Have participated in any clinical trial or taken any study drug within 3 months before dosing;
  • Viral hepatitis（including CHB and CHC）and positive test result of anti-HIV Ab or syphilis.

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: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 50 mg single dose
It includes two group, one group is pilot study, healthy subjects receive a single dose of 50 mg HEC74647PA capsule (N=2) . Another group is formal study, healthy subjects receive a single dose of 50 mg HEC74647PA capsule (N=8) or matching placebo (N=2).
Medicin: placebo
Matchende placebokapsel
Medicin: HEC74647PA Capsule
Capsule administered orally once daily
Eksperimentel: 100 mg single dose
Healthy subjects, receiving a single dose of 100 mg HEC74647PA capsule (N=8) or matching placebo (N=2).
Medicin: placebo
Matchende placebokapsel
Medicin: HEC74647PA Capsule
Capsule administered orally once daily
Eksperimentel: 200 mg single dose
Healthy subjects, receiving a single dose of 200 mg HEC74647PA capsule (N=16) or matching placebo (N=2) under fed or fasted conditions, this group is a two-sequence, two-period crossover study.
Medicin: placebo
Matchende placebokapsel
Medicin: HEC74647PA Capsule
Capsule administered orally once daily
Eksperimentel: 400 mg single dose
Healthy subjects, receiving a single dose of 400 mg HEC74647PA capsule (N=8) or matching placebo (N=2).
Medicin: placebo
Matchende placebokapsel
Medicin: HEC74647PA Capsule
Capsule administered orally once daily
Eksperimentel: 600 mg single dose
Healthy subjects, receiving a single dose of 600 mg HEC74647PA capsule (N=8) or matching placebo (N=2).
Medicin: placebo
Matchende placebokapsel
Medicin: HEC74647PA Capsule
Capsule administered orally once daily
Eksperimentel: 800 mg single dose
Healthy subjects, receiving a single dose of 800 mg HEC74647PA capsule (N=8) or matching placebo (N=2).
Medicin: placebo
Matchende placebokapsel
Medicin: HEC74647PA Capsule
Capsule administered orally once daily
Eksperimentel: 100 mg multiple doses
Healthy subjects, receiving 100 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days.
Medicin: placebo
Matchende placebokapsel
Medicin: HEC74647PA Capsule
Capsule administered orally once daily
Eksperimentel: 200 mg multiple doses
Healthy subjects, receiving 200 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days.
Medicin: placebo
Matchende placebokapsel
Medicin: HEC74647PA Capsule
Capsule administered orally once daily
Eksperimentel: 400 mg multiple doses
Healthy subjects, receiving 400 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days.
Medicin: placebo
Matchende placebokapsel
Medicin: HEC74647PA Capsule
Capsule administered orally once daily

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adverse events of the single ascending-dose
Tidsramme: Baseline to day 6~13
To assess the tolerability after a single dose of HEC74647PA capsule
Baseline to day 6~13
Adverse events of the multiple ascending-dose
Tidsramme: Baseline to day 12
To assess the tolerability after multiple doses of HEC74647PA capsule
Baseline to day 12
Tmax
Tidsramme: Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
Time of the maximum observed plasma concentration
Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
AUC
Tidsramme: Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
Area under the plasma concentration-time curve (AUC)
Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
Cmax
Tidsramme: Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
Maximum observed plasma concentration of HEC74647
Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
T1/2
Tidsramme: Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
Terminal elimination half-life
Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
Vz/F
Tidsramme: Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
Apparent volume of distribution
Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
CL/F
Tidsramme: Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
Oral clearance
Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
MRT
Tidsramme: Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
Mean Residence Time
Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing

Samarbejdspartnere og efterforskere

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

Sponsor

Sunshine Lake Pharma Co., Ltd.

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)

4. september 2018

Primær færdiggørelse (Faktiske)

2. juli 2019

Studieafslutning (Faktiske)

5. juli 2019

Datoer for studieregistrering

Først indsendt

10. september 2018

Først indsendt, der opfyldte QC-kriterier

13. september 2018

Først opslået (Faktiske)

17. september 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. marts 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. marts 2020

Sidst verificeret

1. september 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HEC74647-P-01

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