- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07588646
Study To Investigate The Potential DDI Between HEC585 And Pirfenidone/Nintedanib In Healthy Subjects
11. mai 2026 oppdatert av: Sunshine Lake Pharma Co., Ltd.
A Single-center, Open-label Study Designed to Assess the Drug-drug Interaction of HEC585 And Pirfenidone/Nintedanib In Healthy Subjects
A single-center, open-label study designed to assess the drug-drug interaction of HEC585 and pirfenidone in healthy male and female subjects.
A single-center, open-label study designed to assess the drug-drug interaction of HEC585 and nintedanib in healthy male subjects.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
33
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Shanghai, Kina
- Shanghai Xuhui Central Hospital
-
-
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
- Voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Subjects who are willing and are able to provide a written informed consent to participate in the study.
- Without Plann for pregnant or sperm/egg donation plan, and voluntary effective contraceptive measures during the trial period and within 3 months after the last dose.
- Subjects aged between 18 and 45 (both inclusive) years old.
- The first part of the study included male and female subjects, and the second part of the study included only male subjects.
- Healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥19 and ≤28 kg/m2 at screening.
- Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram (ECG).
Exclusion Criteria:
- Subjects with a positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV) antibodies and/or TP antibodies at screening.
- Subjects suffering from gastrointestinal diseases that can interfere with absorption or metabolism of drugs within 6 months before screening; and/or with history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immune system (such as thymus disease), reproductive system (such as prostate, testis, epididymis, ovarian disease); and/or mental illness.
- Subjects with photosensitivity and/or other skin diseases.
- Subjects with Bleeding risk.
- Subjects with known allergic history or constitution to peanuts, soybeans, study drugs or any of their components.
- Take any prescription or non-prescription medications within 14 days prior to initial dosing, or take any medications known to inhibit or induce cytochrome P enzyme drug metabolism within 28 days prior to initial dosing.
- Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
- Positive results from urine drug screen test.
- History of alcoholism or drink regularly within 3 months prior to the study(defined as Alcohol consumption of > 21 units/week), or positive results from alcohol breath test.
- For the first part of the study, subjects who had positive urine cotinine test or had smoked within 1 month before administration; for the second part of the study, subjects who had smoked more than 10 cigarettes per day within 3 months before administration.
- Donate blood or lose blood 400 mL or more within 3 months prior to initial dosing.
- Subjects who plan to receive or have had organ transplants.
- Females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential.
- Subjects who participated in the other clinical trial within 3 months prior to initial dosing.
- Others conditions that are not suitable for clinical trial participation.
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: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: HEC585 and Pirfenidone
The DDI study of HEC585 and Pirfenidone
|
DDI of HEC585 and Pirfenidone:HEC585, once daily,D5-D14 and D18-D27; DDI of HEC585 and Nintedanib:HEC585,once daily,D14-D23 and D27-D36
DDI of HEC583 and Pirfenidone: Pirfenidone:three times a day,D1-D3 and D25-D27
|
|
Eksperimentell: HEC585 and Nintedanib
The DDI study of HEC585 and Nintedanib
|
DDI of HEC585 and Pirfenidone:HEC585, once daily,D5-D14 and D18-D27; DDI of HEC585 and Nintedanib:HEC585,once daily,D14-D23 and D27-D36
DDI of HEC585 andNintedanib:Nintedanib,twice a day,D1-D7 and D30-D36
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Area under the curve from 0 to 24 hours [AUC (0~24)]
Tidsramme: Day 3 for Pirfenidone monotherapy phase; Day 14 for HEC585 monotherapy phase; Day 27 for Combination phase.
|
Area under the curve from 0 to 24 hours under steady-state conditions for HEC585 and Pirfenidone
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Day 3 for Pirfenidone monotherapy phase; Day 14 for HEC585 monotherapy phase; Day 27 for Combination phase.
|
|
Maximum Plasma Concentration (Cmax)
Tidsramme: Day 3 for Pirfenidone monotherapy phase; Day 14 for HEC585 monotherapy phase; Day 27 for Combination phase.
|
Maximum Observed Plasma Concentration under steady-state conditions for Pirfenidone and HEC585
|
Day 3 for Pirfenidone monotherapy phase; Day 14 for HEC585 monotherapy phase; Day 27 for Combination phase.
|
|
Area under the curve from 0 to 24 hours [AUC (0~24)]
Tidsramme: Day 7 for Nintedanib monotherapy phase; Day 23 for HEC585 monotherapy phase; Day 36 for Combination phase.
|
Area under the curve from 0 to 24 hours under steady-state conditions for HEC585 and Nintedanib
|
Day 7 for Nintedanib monotherapy phase; Day 23 for HEC585 monotherapy phase; Day 36 for Combination phase.
|
|
Observed Plasma Concentration (Cmax)
Tidsramme: Day 7 for Nintedanib monotherapy phase; Day 23 for HEC585 monotherapy phase; Day 36 for Combination phase.
|
Observed Plasma Concentration under steady-state conditions for HEC585 and Nintedanib
|
Day 7 for Nintedanib monotherapy phase; Day 23 for HEC585 monotherapy phase; Day 36 for Combination phase.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of treatment-emergent adverse events (TEAEs)
Tidsramme: up to 31 days(HEC585 and Pirfenidone)
|
Incidence of treatment-emergent adverse events (TEAEs)assessed by CTCAE V5.0
|
up to 31 days(HEC585 and Pirfenidone)
|
|
Incidence of treatment-emergent adverse events (TEAEs)
Tidsramme: up to 40 days(HEC585 and Nintedanib)
|
Incidence of treatment-emergent adverse events (TEAEs)assessed by CTCAE V5.0
|
up to 40 days(HEC585 and Nintedanib)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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 (Faktiske)
29. juni 2021
Primær fullføring (Faktiske)
30. november 2021
Studiet fullført (Faktiske)
30. november 2021
Datoer for studieregistrering
Først innsendt
29. mars 2022
Først innsendt som oppfylte QC-kriteriene
11. mai 2026
Først lagt ut (Faktiske)
15. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. mai 2026
Sist bekreftet
1. mars 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HEC585-P-04/CRC-C2032
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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