A Study to Estimate Effect of Formulation and Food on Relative Bioavailability of HRS-6209 in Healthy Participants
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
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Fase 1
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Jian Li
- Telefonnummer: +86-0518-82342973
- E-mail: jian.li.jl611@hengrui.com
Undersøgelse Kontakt Backup
- Navn: Qiushi Xie
- Telefonnummer: +86-0518-82342973
- E-mail: qiushi.xie.qx8@hengrui.com
Studiesteder
-
-
Fujian
-
Fuzhou, Fujian, Kina, 350001
- Fuzhou University Affiliated Provincial Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Healthy men and women aged 18 to 50 years old at informed consent signing.
- Male body weight ≥ 50 kg, female ≥ 45 kg; BMI 19 to 26 kg/m² at screening and baseline.
- Have no clinically significant abnormalities at screening and baseline.
- 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:
- 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.
- 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).
- 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.
- 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.
- Positive for anti-HCV, anti-HIV, HBsAg, or syphilis antibodies.
- 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.
- 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.
- Participation in another clinical trial with investigational drug within 3 months; vaccination within 3 months prior to screening or planned during study.
- History of drug abuse/dependence; positive urine drug screen at screening.
- 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.
- 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.
- Special dietary requirements or inability to comply with standardized meals.
- Dysphagia, difficulty with venous blood collection, or inability to tolerate intensive blood sampling.
- Other conditions that, in the investigator's judgment, make the participant unsuitable for the study.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / 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
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Area under the concentration time curve (AUC)
Tidsramme: Day 1 - Day 9.
|
pharmacokinetics (PK) parameter of HRS-6209.
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Day 1 - Day 9.
|
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Maximum Plasma Concentration (Cmax)
Tidsramme: Day 1 - Day 9.
|
pharmacokinetics (PK) parameter of HRS-6209.
|
Day 1 - Day 9.
|
Sekundære resultatmål
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
Sponsor
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- HRS-6209-102
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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