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Uno studio in aperto dopo la somministrazione orale di Seladelpar a soggetti con colangite biliare primitiva (PBC) e compromissione epatica (HI)

13 aprile 2026 aggiornato da: Gilead Sciences

L'effetto dell'insufficienza epatica sulla farmacocinetica di Seladelpar: uno studio in aperto dopo la somministrazione orale di Seladelpar a soggetti con colangite biliare primitiva (PBC) e insufficienza epatica

L'effetto della compromissione epatica sulla farmacocinetica di Seladelpar: uno studio in aperto dopo la somministrazione orale di Seladelpar a soggetti con colangite biliare primitiva (PBC) e compromissione epatica (HI)

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

24

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Corea del Sud
      • Busan, Corea del Sud, 49241
        • Pusan National University Hospital
      • Busan, Corea del Sud
        • Inje University Busan Paik Hospital
      • Daegu, Corea del Sud, 41944
        • Kyungpook National University Hospital
      • Seoul, Corea del Sud, 3080
        • Seoul National University Hospital
      • Seoul, Corea del Sud, 3722
        • Severance Hospital Yonsei University Health System
  • Regno Unito
      • Birmingham, Regno Unito, B15 2GW
        • NIHR BRC Centre for Liver and Gastrointestinal Research Birmingham
      • London, Regno Unito, SE5 9RS
        • Kings College Hospital
      • London, Regno Unito, NW2 2QG
        • The Royal Free London NHS Foundation Trust
  • Spagna
      • Madrid, Spagna, 28007
        • Hospital General Universitario Gregorio Maran
  • Stati Uniti
    • Arizona
      • Chandler, Arizona, Stati Uniti, 85224
        • Arizona Liver Health
    • California
      • Sacramento, California, Stati Uniti, 95817
        • University of California Davis
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80045
        • University of Colorado Anschutz
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21202
        • Mercy Medical Center
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02114
        • Massachusetts General Hospital
    • Michigan
      • Novi, Michigan, Stati Uniti, 48377
        • Henry Ford Health System
    • Mississippi
      • Jackson, Mississippi, Stati Uniti, 39216
        • Southern Therapy and Advanced Research LLC
    • New York
      • New York, New York, Stati Uniti, 10021
        • Weill Medical College of Cornell University
    • Texas
      • Dallas, Texas, Stati Uniti, 75203
        • The Liver Institute at Methodist Dallas Medical Center
      • San Antonio, Texas, Stati Uniti, 78215
        • American Research Corporation
      • San Antonio, Texas, Stati Uniti, 78229
        • Pinnacle Clinical Research- SA

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Descrizione

Criterio di inclusione:

  1. Maschi e femmine di età compresa tra i 18 e gli 80 anni (inclusi) che sono in grado di comprendere le istruzioni e seguire le procedure dello studio e sono disposti a firmare un modulo di consenso informato (ICF)
  2. Le donne in età fertile che sono sessualmente attive con un partner maschile non sterile (i partner maschili sterili sono definiti come uomini vasectomizzati da almeno 6 mesi) devono essere disposti a utilizzare i metodi contraccettivi durante lo studio e per 30 giorni dopo la somministrazione del farmaco in studio.
  3. Per almeno 90 giorni dopo la somministrazione del farmaco in studio, i maschi non vasectomizzati non devono donare lo sperma, essere disposti a usare la contraccezione con potenziali partner fertili e qualsiasi soggetto maschio con una partner incinta deve usare un preservativo.
  4. - Disponibilità ad astenersi dal consumo di prodotti contenenti pompelmo, pomelo, carambola o arancia di Siviglia da 7 giorni prima della dose del farmaco in studio fino al giorno della dimissione.
  5. Diagnosi confermata di PBC con evidenza di cirrosi e classificazione Child-Pugh di CP-A, CP-A + PHT, CP-B o CP-C

  6. Parametri di laboratorio di screening:

    • ALP, ALT e AST < 10 × ULN
    • Bilirubina totale ≤ 5 × ULN
  7. Acido ursodesossicolico (UDCA) per un minimo di 12 settimane di trattamento prima del Giorno 1
  8. Allo screening diagnosi confermata di PBC
  9. Punteggi MELD-Na da 6 a 24

Criteri di esclusione:

  1. Clinicamente significativo o anamnesi di malattia epatica acuta o cronica di eziologia diversa dalla CBP
  2. Pazienti con diagnosi di sovrapposizione di PBC ed epatite autoimmune
  3. Anamnesi, evidenza o alto sospetto di neoplasia epatobiliare sulla base di imaging, screening dei valori di laboratorio e/o sintomi clinici.
  4. Infezione presunta o diagnosticata che richiede una terapia sistemica entro 12 settimane dallo screening e fino al giorno 1
  5. Soggetti di sesso femminile in gravidanza o in allattamento
  6. ECG di screening che dimostri un intervallo QT ≥ 500 msec o qualsiasi altro risultato ECG significativo con anomalie clinicamente significative come determinato dallo sperimentatore
  7. Positivo per HBsAg, HCV RNA o anticorpo anti HIV
  8. Qualsiasi condizione acuta o cronica non epatica che, a giudizio dello sperimentatore, limiterebbe la capacità del paziente di completare e/o partecipare allo studio o comprometterebbe l'integrità dei dati
  9. - Ha manifestato una malattia considerata clinicamente significativa dallo sperimentatore entro 2 settimane prima della somministrazione del prodotto sperimentale
  10. Abuso di droghe o alcol clinicamente rilevante entro 6 mesi dallo screening. Uno screening antidroga positivo escluderà i soggetti a meno che non possa essere spiegato da un farmaco prescritto
  11. Uso di acido obeticolico (OCA), qualsiasi farmaco della stessa classe o fibrati (ad es. bezafibrato, fenofibrato, elafibranor, lanifibranor, pemafibrato, saroglitizar) entro 30 giorni dal basale
  12. Uso di un trattamento sperimentale o non approvato per PBC entro 30 giorni dal basale
  13. Complicazioni clinicamente evidenti di cirrosi e ipertensione portale che hanno richiesto una visita al pronto soccorso, il ricovero in ospedale o entrambi durante il periodo di 12 settimane prima della somministrazione del prodotto sperimentale

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Part A: Cohort 1 - CP-A Without PHT (Seladelpar 10 mg)
Participants with primary biliary cholangitis (PBC) and a Child-Pugh (CP) classification of CP-A (score 5 to 6) without portal hypertension (PHT) will receive a single dose of seladelpar 10 mg, orally, on Day 1.
Droga: Seladelpar
Tablets Administered Orally
Altri nomi:
  • Livdelzi®
Sperimentale: Part A: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT will receive a single dose of seladelpar 10 mg, orally, on Day 1.
Droga: Seladelpar
Tablets Administered Orally
Altri nomi:
  • Livdelzi®
Sperimentale: Part A: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9) will receive a single dose of seladelpar 10 mg, orally, on Day 1.
Droga: Seladelpar
Tablets Administered Orally
Altri nomi:
  • Livdelzi®
Sperimentale: Part A: Cohort 4 - CP-C (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-C (score 10 to 12) will receive a single dose of seladelpar 10 mg, orally, on Day 1.
Droga: Seladelpar
Tablets Administered Orally
Altri nomi:
  • Livdelzi®
Sperimentale: Experimental: Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg or 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who complete Part A, will receive seladelpar 10 mg or 5 mg, orally, once daily, for 28 days. Doses for Part B will be chosen based on exposure from a single dose in Part A for individual participants.
Droga: Seladelpar
Tablets Administered Orally
Altri nomi:
  • Livdelzi®
Sperimentale: Experimental: Part B: Cohort 3 - CP-B (Seladelpar 5 mg or 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who complete Part A, will receive seladelpar 10 mg or 5 mg, orally, once daily, for 28 days. Doses for Part B will be chosen based on exposure from a single dose in Part A for individual participants.
Droga: Seladelpar
Tablets Administered Orally
Altri nomi:
  • Livdelzi®

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Part A: Pharmacokinetic (PK) Parameter: Cmax of Seladelpar and Its Metabolites (M1, M2, and M3)
Lasso di tempo: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Cmax is defined as the maximum observed plasma concentration of the study drug.
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Part A: PK Parameter: Tmax of Seladelpar and Its Metabolites (M1, M2, and M3)
Lasso di tempo: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Tmax is defined as the time to reach the maximum observed plasma concentration of the study drug.
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Part A: PK Parameter: AUC0-t of Seladelpar and Its Metabolites (M1, M2, and M3)
Lasso di tempo: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
AUC0-t is defined as area under the concentration--time curve from time zero to the last measurable concentration.
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Part A: PK Parameter: AUC0-inf of Seladelpar and Its Metabolites (M1, M2, and M3)
Lasso di tempo: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
AUC0-inf is defined as area under the concentration--time curve from time zero extrapolated to infinity, calculated as AUC0-t+Ct/Kel, where: Ct = the last measurable concentration and Kel = elimination rate constant.
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Part B: PK Parameter: Cmax of Seladelpar and Its Metabolites (M1, M2, and M3)
Lasso di tempo: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
Cmax is defined as the maximum observed plasma concentration of the study drug.
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
Part B: PK Parameter: Cmax,ss of Seladelpar and Its Metabolites (M1, M2, and M3)
Lasso di tempo: Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose
Cmax,ss is defined as the steady-state maximum observed plasma concentration of the study drug at Day 28.
Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose
Part B: PK Parameter: Tmax of Seladelpar and Its Metabolites (M1, M2, and M3)
Lasso di tempo: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
Tmax is defined as the time to reach the maximum observed plasma concentration of the study drug.
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
Part B: PK Parameter: Tmax,ss of Seladelpar and Its Metabolites (M1, M2, and M3)
Lasso di tempo: Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose
Tmax,ss is defined as the steady-state time to reach maximum observed plasma concentration of the study drug at Day 28.
Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose
Part B: PK Parameter: AUC0-24 of Seladelpar and Its Metabolites (M1, M2, and M3)
Lasso di tempo: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
AUC0-24 is defined as area under the concentration-time curve from time zero to 24 hours.
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
Part B: PK Parameter: AUC0-tau of Seladelpar and Its Metabolites (M1, M2, and M3)
Lasso di tempo: Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose
AUCtau is defined as the area under the drug concentration versus time curve over the dosing interval.
Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose
Part B: PK Parameter: RCmax of Seladelpar and Its Metabolites (M1, M2, and M3)
Lasso di tempo: Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose
RCmax is defined as the accumulation ratio based on Cmax, calculated as Cmax on Day 28/ Day 1.
Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose
Part B: PK Parameter: RAUC0-t of Seladelpar and Its Metabolites (M1, M2, and M3)
Lasso di tempo: Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose
RAUC0-t is defined as the accumulation ratio based on AUC0-t, calculated as AUC0-tau on Day 28/ AUC0-24 on Day 1 for participants with dose once a day.
Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose
Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) and Study Drug-Related TEAEs
Lasso di tempo: Part A: Up to Week 5; Part B: Up to Week 8
An adverse event (AE) was defined as any medical occurrence in a participant administered to a pharmaceutical product in a clinical study, regardless of a causal relationship with this treatment. TEAEs were defined as AEs that commenced or worsened on or after the time of study drug administration in Part A until up to 30 days after study drug administration in Part A or before the first study drug administration in Part B (whichever is earlier). For Part B, TEAEs are defined as AEs that commence or worsen on or after the time of first study drug administration in Part B until up to 30 days after the last study drug administration in Part B. A drug-related TEAE was defined as TEAE which was related (reported as 'possible', 'probable', or 'definite') to study drug. Percentages were rounded off.
Part A: Up to Week 5; Part B: Up to Week 8
Percentage of Participants Who Experienced Any Grade and Grade 3 or 4 TEAEs
Lasso di tempo: Part A: Up to Week 5; Part B: Up to Week 8
TEAEs severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. Participants were counted at the highest AE grade experienced. The percentage of participants with any severity grade and severity grade of 3 or 4 were reported. Percentages were rounded off.
Part A: Up to Week 5; Part B: Up to Week 8
Percentage of Participants Who Experienced TEAEs of Special Interest
Lasso di tempo: Part A: Up to Week 5; Part B: Up to Week 8
TEAEs of special interest for this study were defined as AEs that met CTCAE version 5.0 or the most recent version Grade 2 criteria or higher for AEs of elevated alanine transaminase (ALT), aspartate aminotransferase (AST), bilirubin, creatinine kinase, lipase, or serum creatinine. Hepatic decompensation clinical events including ascites, jaundice, esophageal variceal bleeding, and hepatic encephalopathy, were also defined as TEAEs of special interest for this study. Percentages were rounded off.
Part A: Up to Week 5; Part B: Up to Week 8
Percentage of Participants With Clinically Significant Changes in Vital Signs
Lasso di tempo: Part A: Up to Day 4; Part B: Up to Day 31
Vital signs (including oral temperature, respiratory rate, seated blood pressure [diastolic and systolic], and heart rate) were evaluated. Percentage of participants with clinically significant changes in vital signs evaluations was reported. The clinically significant changes were based on investigator's judgement.
Part A: Up to Day 4; Part B: Up to Day 31
Percentage of Participants With Abnormal Clinically Significant 12-Lead Electrocardiogram (ECG) Findings
Lasso di tempo: Part A: Up to Day 4; Part B: Up to Day 28
ECG measurements included the parameters of heart rate, ventricular rate, PR interval, QRS duration, QT interval (uncorrected), and QT interval corrected for heart rate according to Fridericia's formula (QTcF). Per protocol, ECG findings were classified in 1 of 3 categories: normal, abnormal but not clinically significant, or abnormal and clinically significant. Any abnormality in ECG assessments which were deemed clinically significant by the investigator were reported.
Part A: Up to Day 4; Part B: Up to Day 28
Percentage of Participants Who Experienced Laboratory Abnormalities
Lasso di tempo: Part A: Up to Day 4; Part B: Up to Day 31
Clinical laboratory parameters included biochemistry, hematology, coagulation, and urinalysis. Abnormal laboratory values were graded according to the NCI CTCAE version 5.0.Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. The percentage of participants with a shift of ≥ 2 NCI CTCAE grade from baseline was reported.
Part A: Up to Day 4; Part B: Up to Day 31

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Part A: PK Parameter (Urine): Ae0-t of Seladelpar and Its Metabolites (M1, M2, and M3)
Lasso di tempo: Day 1: Predose; 0-6 h, and 6-12 h postdose
Ae0-t is defined as the cumulative urinary excretion from time zero to time t, calculated as the sum of the amounts excreted over each collection interval.
Day 1: Predose; 0-6 h, and 6-12 h postdose
Part A: PK Parameter (Urine): CLR of Seladelpar
Lasso di tempo: Day 1: Predose; 0-6 h, and 6-12 h postdose
CLR is defined as the renal clearance, calculated as Ae0-t / AUC0-12.
Day 1: Predose; 0-6 h, and 6-12 h postdose
Part A: Rsq Between Plasma Seladelpar Cmax and Baseline Albumin
Lasso di tempo: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Rsq is defined as the R-squared value for the regression between Cmax and Baseline Albumin.
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Part A: Rsq Between Plasma Seladelpar AUC0-inf and Baseline Albumin
Lasso di tempo: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Rsq is defined as the R-squared value for the regression between AUC0-inf and Baseline Albumin.
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Part A: Rsq Between Plasma Seladelpar AUC0-t and Baseline Albumin
Lasso di tempo: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Rsq is defined as the R-squared value for the regression between AUC0-t and Baseline Albumin.
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Part A: Rsq Between Plasma Seladelpar Cmax and Baseline Bilirubin
Lasso di tempo: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Rsq is defined as the R-squared value for the regression between Cmax and Baseline Bilirubin.
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Part A: Rsq Between Plasma Seladelpar AUC0-inf and Baseline Bilirubin
Lasso di tempo: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Rsq is defined as the R-squared value for the regression between AUC0-inf and Baseline Bilirubin.
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Part A: Rsq Between Plasma Seladelpar AUC0-t and Baseline Bilirubin
Lasso di tempo: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Rsq is defined as the R-squared value for the regression between AUC0-t and Baseline Bilirubin.
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Part A: Rsq Between Plasma Seladelpar Cmax and Baseline Prothrombin Time
Lasso di tempo: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Rsq is defined as the R-squared value for the regression between Cmax and Baseline Prothrombin Time.
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Part A: Rsq Between Plasma Seladelpar AUC0-inf and Baseline Prothrombin Time
Lasso di tempo: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Rsq is defined as the R-squared value for the regression between AUC0-inf and Baseline Prothrombin Time.
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Part A: Rsq Between Plasma Seladelpar AUC0-t and Baseline Prothrombin Time
Lasso di tempo: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Rsq is defined as the R-squared value for the regression between AUC0-t and Baseline Prothrombin Time.
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Part A: Rsq Between Plasma Seladelpar Cmax and CP Score
Lasso di tempo: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Rsq is defined as the R-squared value for the regression between Cmax and CP score of participants.
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Part A: Rsq Between Plasma Seladelpar AUC0-inf and CP Score
Lasso di tempo: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Rsq is defined as the R-squared value for the regression between AUC0-inf and CP score of participants.
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Part A: Rsq Between Plasma Seladelpar AUC0-t and CP Score
Lasso di tempo: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Rsq is defined as the R-squared value for the regression between AUC0-t and CP score of participants.
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Part B: Rsq Between Plasma Seladelpar Cmax and Baseline Albumin
Lasso di tempo: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
Rsq is defined as the R-squared value for the regression between Cmax and baseline Albumin.
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
Part B: Rsq Between Plasma Seladelpar AUC0-t and Baseline Albumin
Lasso di tempo: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose; Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose
Rsq is defined as the R-squared value for the regression between AUC0-t and baseline Albumin.
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose; Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose
Part B: Rsq Between Plasma Seladelpar AUC0-inf and Baseline Albumin
Lasso di tempo: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
Rsq is defined as the R-squared value for the regression between AUC0-inf and baseline Albumin.
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
Part B: Rsq Between Plasma Seladelpar Cmax and Baseline Prothrombin Time
Lasso di tempo: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
Rsq is defined as the R-squared value for the regression between Cmax and baseline prothrombin time.
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
Part B: Rsq Between Plasma Seladelpar AUC0-t and Baseline Prothrombin Time
Lasso di tempo: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose; Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose
Rsq is defined as the R-squared value for the regression between AUC0-t and baseline prothrombin time.
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose; Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose
Part B: Rsq Between Plasma Seladelpar AUC0-inf and Baseline Prothrombin Time
Lasso di tempo: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
Rsq is defined as the R-squared value for the regression between AUC0-inf and baseline prothrombin time.
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
Part B: Rsq Between Plasma Seladelpar Cmax and Baseline Bilirubin
Lasso di tempo: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
Rsq is defined as the R-squared value for the regression between Cmax and baseline bilirubin.
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
Part B: Rsq Between Plasma Seladelpar AUC0-t and Baseline Bilirubin
Lasso di tempo: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose; Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose
Rsq is defined as the R-squared value for the regression between AUC0-t and baseline bilirubin.
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose; Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose
Part B: Rsq Between Plasma Seladelpar AUC0-inf and Baseline Bilirubin
Lasso di tempo: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
Rsq is defined as the R-squared value for the regression between AUC0-inf and baseline bilirubin.
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
Part B: Rsq Between Plasma Seladelpar Cmax and CP Score
Lasso di tempo: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
Rsq is defined as the R-squared value for the regression between Cmax and CP score of participants.
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
Part B: Rsq Between Plasma Seladelpar AUC0-t and CP Score
Lasso di tempo: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose; Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose
Rsq is defined as the R-squared value for the regression between AUC0-t and and CP score of participants.
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose; Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose
Part B: Rsq Between Plasma Seladelpar AUC0-inf and CP Score
Lasso di tempo: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
Rsq is defined as the R-squared value for the regression between AUC0-inf and and CP score of participants.
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Gilead Sciences

Investigatori

  • Direttore dello studio: Gilead Study Director, Gilead Sciences

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

16 novembre 2021

Completamento primario (Effettivo)

24 febbraio 2025

Completamento dello studio (Effettivo)

27 febbraio 2025

Date di iscrizione allo studio

Primo inviato

14 giugno 2021

Primo inviato che soddisfa i criteri di controllo qualità

25 giugno 2021

Primo Inserito (Effettivo)

6 luglio 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CB8025-21838
  • 2020-005925-10 (Numero EudraCT: EU Trial (CTIS) Number)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Qualified external researchers may request IPD for this study. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy#Commitment

Periodo di condivisione IPD

18 months after study completion and at least 6 months after the FDA and EMA approval

Criteri di accesso alla condivisione IPD

A secured external environment with username, password, and RSA code.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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