Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

A Study to Estimate Effect of Formulation and Food on Relative Bioavailability of HRS-6209 in Healthy Participants

20. maj 2026 opdateret af: Jiangsu HengRui Medicine Co., Ltd.

A Single-Center, Single-Dose, Randomized, Open-Label, Three-Period, Three-Sequence, Crossover Study to Evaluate the Oral Relative Bioavailability of Old and New Formulations of HRS-6209 Capsules and the Effect of Food in Healthy Chinese Participants

This is a phase 1, randomised, open-label, three-way, three-period, crossover relative bioavailability study to assess the pharmacokinetics of HRS-6209 capsules (old and new formulation) in healthy participants. The effect of high-fat food on the pharmacokinetics of HRS-6209 in new formulation will also be evaluated. A total of 21 healthy participants will be randomised to receive a single oral dose of HRS-6209 in three treatment periods: old formulation (fasted); new formulation (fasted); new formulation (fasted).

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

21

Fase

  • Fase 1

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

    • Fujian
      • Fuzhou, Fujian, Kina, 350001
        • Fuzhou University Affiliated Provincial Hospital
        • Ledende efterforsker:
          • Jie Shen
        • Kontakt:

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

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  1. Healthy men and women aged 18 to 50 years old at informed consent signing.
  2. Male body weight ≥ 50 kg, female ≥ 45 kg; BMI 19 to 26 kg/m² at screening and baseline.
  3. Have no clinically significant abnormalities at screening and baseline.
  4. Fertile females and males with fertile female partners: effective contraception 2 weeks before consent, and sustained until 6 months after the last dose (abstinence or highly effective contraception); no sperm/egg donation.

Exclusion Criteria:

  1. Current or history of clinically significant disorders of any major system (urinary, circulatory, endocrine, nervous, digestive, respiratory, hematologic, immune, psychiatric, metabolic, etc.) or any other condition that may interfere with study results per investigator judgment.
  2. History of epilepsy, including febrile seizures in childhood, loss of consciousness, transient ischemic attack, or any condition predisposing to seizures (e.g., cerebrovascular disease, brain injury, stroke, brain cancer).
  3. Clinically significant acute illness within 1 month prior to screening, including fever or febrile symptoms, viral, bacterial (including upper respiratory tract infection), or non-cutaneous fungal infections.
  4. Any surgery within 6 months prior to study, or planned surgery during study period; prior surgery affecting gastrointestinal absorption (including gastrectomy, bowel resection, bariatric surgery) or affecting liver function.
  5. Positive for anti-HCV, anti-HIV, HBsAg, or syphilis antibodies.
  6. Blood donation or loss ≥ 400 mL within 3 months, or ≥ 200 mL within 1 month prior to screening; blood transfusion or use of blood products within 3 months prior to screening.
  7. Long-term use (> 7 consecutive days) of hepatotoxic drugs within 6 months; use of any drug affecting liver metabolism within 1 month prior to first dose; use of other drugs (prescription, OTC, herbal, vitamins, calcium, etc.) within 14 days prior to first dose, other than those affecting liver metabolism.
  8. Participation in another clinical trial with investigational drug within 3 months; vaccination within 3 months prior to screening or planned during study.
  9. History of drug abuse/dependence; positive urine drug screen at screening.
  10. History of heavy smoking (average ≥ 5 cigarettes/day) within 3 months prior to screening; inability to abstain from any tobacco products during study; positive smoke screen.
  11. Alcoholism (average daily intake exceeding: > 14 units/week; 1 unit = 285 mL beer, 25 mL spirits, or 100 mL wine); positive alcohol screen; inability to abstain from alcohol during study.
  12. Special dietary requirements or inability to comply with standardized meals.
  13. Dysphagia, difficulty with venous blood collection, or inability to tolerate intensive blood sampling.
  14. Other conditions that, in the investigator's judgment, make the participant unsuitable for the study.

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: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Participants receiving treatment sequence A+C+B
Treatment sequence A = HRS-6209 capsule old formulation given in fasted state; Treatment sequence B = HRS-6209 capsule new formulation given in fasted state; Treatment sequence C = HRS-6209 capsule new formulation given in fed state.
Oral administration after fasting.
Oral administration after fasting/high-fat meal.
Eksperimentel: Participants receiving treatment sequence C+B+A
Treatment sequence A = HRS-6209 capsule old formulation given in fasted state; Treatment sequence B = HRS-6209 capsule new formulation given in fasted state; Treatment sequence C = HRS-6209 capsule new formulation given in fed state.
Oral administration after fasting.
Oral administration after fasting/high-fat meal.
Eksperimentel: Participants receiving treatment sequence B+A+C
Treatment sequence A = HRS-6209 capsule old formulation given in fasted state; Treatment sequence B = HRS-6209 capsule new formulation given in fasted state; Treatment sequence C = HRS-6209 capsule new formulation given in fed state.
Oral administration after fasting.
Oral administration after fasting/high-fat meal.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Area under the concentration time curve (AUC)
Tidsramme: Day 1 - Day 9.
pharmacokinetics (PK) parameter of HRS-6209.
Day 1 - Day 9.
Maximum Plasma Concentration (Cmax)
Tidsramme: Day 1 - Day 9.
pharmacokinetics (PK) parameter of HRS-6209.
Day 1 - Day 9.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence and severity of adverse events / serious adverse events (AEs / SAEs)
Tidsramme: Up to 1 month.
Safety assessment, graded as per CTCAE 6.0.
Up to 1 month.

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 (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

1. juni 2026

Studieafslutning (Anslået)

1. juni 2026

Datoer for studieregistrering

Først indsendt

20. maj 2026

Først indsendt, der opfyldte QC-kriterier

20. maj 2026

Først opslået (Faktiske)

27. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • HRS-6209-102

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 .

Kliniske forsøg med Brystkræft

Kliniske forsøg med HRS-6209 Capsule (old formulation)

Abonner