- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03673696
The Tolerability and Pharmacokinetics Study of HEC74647PA Capsule in Healthy Adult Subjects
17. mars 2020 oppdatert av: 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
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
105
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Jilin
-
Changchun, Jilin, Kina, 130021
- The First Hospital of Jilin University
-
-
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 45 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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).
|
Matchende placebokapsel
Capsule administered orally once daily
|
|
Eksperimentell: 100 mg single dose
Healthy subjects, receiving a single dose of 100 mg HEC74647PA capsule (N=8) or matching placebo (N=2).
|
Matchende placebokapsel
Capsule administered orally once daily
|
|
Eksperimentell: 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.
|
Matchende placebokapsel
Capsule administered orally once daily
|
|
Eksperimentell: 400 mg single dose
Healthy subjects, receiving a single dose of 400 mg HEC74647PA capsule (N=8) or matching placebo (N=2).
|
Matchende placebokapsel
Capsule administered orally once daily
|
|
Eksperimentell: 600 mg single dose
Healthy subjects, receiving a single dose of 600 mg HEC74647PA capsule (N=8) or matching placebo (N=2).
|
Matchende placebokapsel
Capsule administered orally once daily
|
|
Eksperimentell: 800 mg single dose
Healthy subjects, receiving a single dose of 800 mg HEC74647PA capsule (N=8) or matching placebo (N=2).
|
Matchende placebokapsel
Capsule administered orally once daily
|
|
Eksperimentell: 100 mg multiple doses
Healthy subjects, receiving 100 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days.
|
Matchende placebokapsel
Capsule administered orally once daily
|
|
Eksperimentell: 200 mg multiple doses
Healthy subjects, receiving 200 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days.
|
Matchende placebokapsel
Capsule administered orally once daily
|
|
Eksperimentell: 400 mg multiple doses
Healthy subjects, receiving 400 mg HEC74647PA capsule (N=10) or placebo(N=2) once daily (q.d.) for 7 days.
|
Matchende placebokapsel
Capsule administered orally once daily
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
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Studer hoveddatoer
Studiestart (Faktiske)
4. september 2018
Primær fullføring (Faktiske)
2. juli 2019
Studiet fullført (Faktiske)
5. juli 2019
Datoer for studieregistrering
Først innsendt
10. september 2018
Først innsendt som oppfylte QC-kriteriene
13. september 2018
Først lagt ut (Faktiske)
17. september 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. mars 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. mars 2020
Sist bekreftet
1. september 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HEC74647-P-01
Plan for individuelle deltakerdata (IPD)
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NEI
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Nei
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Nei
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