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A Trial to Examine if Repinatrabit is Processed Differently in Adults With Reduced Liver or Kidney Function Compared to Adults With Normal Liver and Kidney Function

A Phase 1, Open-label, Single-dose, Parallel-group Study Evaluating the Pharmacokinetics of Oral Repinatrabit (JNT-517) Immediate Release Tablet in Hepatic or Renal Impaired Adult Participants Matched to Adult Participants With Normal Hepatic and Renal Function

This trial is intended to understand how the body processes repinatrabit in people with moderate liver impairment and severe kidney impairment and also to compare these results with people of similar age, weight, and sex who have normal liver function.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

32

Fase

  • Fase 1

Kontakter og lokationer

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

Studiekontakt

Studiesteder

    • Florida
      • Miami, Florida, Forenede Stater, 33014
        • Rekruttering
        • Panax Clinical Research

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
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion criteria:

  1. Body mass index (BMI) from 18.0 to 38.0 kilograms per square meter (kg/m^2) (inclusive).
  2. Able to provide written, informed consent.
  3. Male participants and female participants of childbearing potential (POCBP) must agree to remain fully abstinent from intercourse where pregnancy can occur OR practice 2 different contraceptive methods, where at least one must be highly effective.
  4. Otherwise be in generally good health.
  5. Additional criteria for Group 1:

    i. Have moderate hepatic impairment determined using Child-Pugh classification (Class B).

    ii. Have relatively stable hepatic function for the duration of the study as determined by the investigator and liver function test at the time of screening or stable hepatic function 1 year prior to screening.

    iii. Have normal renal function. iv. Have a clinical diagnosis of hepatic cirrhosis based on biopsy and/or clinical criteria.

  6. Additional criteria for Group 2:

    i. Have estimated glomerular filtration rate based on the Chronic Kidney Disease-Epidemiology Collaboration (eGFRCKD-EPI) lesser than (<) 30 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2) indicating severe renal impairment.

ii. Not currently be on dialysis. iii. Have relatively stable renal function as determined by eGFRCKD-EPI. 7) Additional criteria for Group 3: i. eGFRCKD-EPI greater than or equal to (≥) 90 mL/min/1.73 m^2 indicating normal renal function.

ii. Have liver enzymes within normal limits.

Exclusion criteria:

  1. Participants who are breastfeeding.
  2. Participants who have a positive pregnancy test result prior to receiving the investigational medical product (IMP).
  3. Participants with international normalized ratio (INR) greater than (>) 2.3. Participants with hepatic impairment with elevated INR will be excluded based on the investigator's discretion.
  4. Participants with hepatic carcinoma or porto-hepatic shunts that have been surgically created or planted.
  5. A history of difficulty in obtaining intravenous access.
  6. The donation of blood or plasma > 250 milliliters (mL) within 30 days prior to screening or received > 50 mL of blood or plasma within 30 days prior to screening.
  7. Participants who have taken an investigational drug within 30 days prior to screening.
  8. Exposure to any substances known to stimulate hepatic microsomal enzymes within 30 days prior to screening (eg, occupational exposure to pesticides, organic solvents, etc).
  9. Any participant who, in the opinion of the investigator, should not participate in the trial.
  10. Previous exposure to repinatrabit.
  11. Additional criteria for Group 1: History of serious mental disorder including participants who have greater than Grade 1 encephalopathy as assessed by the Child-Pugh score and/or the investigator's judgment.
  12. Additional criteria for Group 2:

    i) Participants that have undergone a renal transplant. ii) Participants expected to require dialysis within 45 days. iii) Clinically significant abnormal findings in the serum chemistry, hematology, or urinalysis results obtained at screening or on Day -1, other than those associated with underlying renal conditions and other stable medical conditions consistent with the disease processes.

  13. Additional criteria for Group 3: History of or current hepatitis, or carriers of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies (anti-HC).

Note: Other protocol-specified inclusion/exclusion criteria may apply.

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: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group 1: Moderate Hepatic Impairment
Participants with moderate hepatic impairment will receive a single dose of repinatrabit tablet, under fasted conditions on Day 1.
Oral tablet
Andre navne:
  • JNT-517
Eksperimentel: Group 2: Severe Renal Impairment
Participants with severe renal impairment will receive a single dose of repinatrabit tablet, under fasted conditions on Day 1.
Oral tablet
Andre navne:
  • JNT-517
Eksperimentel: Group 3: Matched Normal Hepatic and Renal Function
Participants matched by age, weight, and sex with normal hepatic and renal function will receive a single dose of repinatrabit tablet, under fasted conditions on Day 1.
Oral tablet
Andre navne:
  • JNT-517

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Groups 1 and 2: Unbound and Total Area Under the Concentration-Time Curve Calculated to the Last Observable Concentration at Time t (AUC0-t) of Repinatrabit
Tidsramme: From Day 1 to Day 8
From Day 1 to Day 8
Groups 1 and 2: Unbound and Total Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Repinatrabit
Tidsramme: From Day 1 to Day 8
From Day 1 to Day 8
Groups 1 and 2: Unbound and Total Maximum (Peak) Plasma Concentration (Cmax) of Repinatrabit
Tidsramme: From Day 1 to Day 8
From Day 1 to Day 8

Sekundære resultatmål

Resultatmål
Tidsramme
All Groups: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Severe Adverse Events (SAEs)
Tidsramme: Up to Day 14
Up to Day 14
All Groups: Number of Participants With Potentially Clinically Relevant Clinical Laboratory Test Results
Tidsramme: Up to Day 8
Up to Day 8
All Groups: Number of Participants With Potentially Clinically Relevant Changes in Vital Signs
Tidsramme: Up to Day 8
Up to Day 8
All Groups: Number of Participants With Potentially Clinically Relevant Changes in Physical Examination Findings
Tidsramme: Up to Day 8
Up to Day 8
All Groups: Number of Participants With Potentially Clinically Relevant Changes in 12-lead Electrocardiogram (ECG) Results
Tidsramme: Up to Day 8
Up to Day 8

Samarbejdspartnere og efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

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)

17. juli 2026

Primær færdiggørelse (Anslået)

9. februar 2027

Studieafslutning (Anslået)

15. februar 2027

Datoer for studieregistrering

Først indsendt

15. juli 2026

Først indsendt, der opfyldte QC-kriterier

15. juli 2026

Først opslået (Faktiske)

20. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

IPD-delingstidsramme

Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.

IPD-delingsadgangskriterier

Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

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 .

Abonner