- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07713758
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
Panoramica dello studio
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 1
Contatti e Sedi
Contatto studio
- Nome: Otsuka Call Center
- Numero di telefono: 844-687-8522
- Email: Otsuka-ProfessionalServices@otsuka-us.com
Luoghi di studio
-
-
Florida
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Miami, Florida, Stati Uniti, 33014
- Reclutamento
- Panax Clinical Research
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion criteria:
- Body mass index (BMI) from 18.0 to 38.0 kilograms per square meter (kg/m^2) (inclusive).
- Able to provide written, informed consent.
- 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.
- Otherwise be in generally good health.
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.
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:
- Participants who are breastfeeding.
- Participants who have a positive pregnancy test result prior to receiving the investigational medical product (IMP).
- 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.
- Participants with hepatic carcinoma or porto-hepatic shunts that have been surgically created or planted.
- A history of difficulty in obtaining intravenous access.
- 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.
- Participants who have taken an investigational drug within 30 days prior to screening.
- Exposure to any substances known to stimulate hepatic microsomal enzymes within 30 days prior to screening (eg, occupational exposure to pesticides, organic solvents, etc).
- Any participant who, in the opinion of the investigator, should not participate in the trial.
- Previous exposure to repinatrabit.
- 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.
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.
- 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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
Altri nomi:
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Sperimentale: 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
Altri nomi:
|
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Sperimentale: 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
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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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
Lasso di tempo: From Day 1 to Day 8
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From Day 1 to Day 8
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Groups 1 and 2: Unbound and Total Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Repinatrabit
Lasso di tempo: From Day 1 to Day 8
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From Day 1 to Day 8
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Groups 1 and 2: Unbound and Total Maximum (Peak) Plasma Concentration (Cmax) of Repinatrabit
Lasso di tempo: From Day 1 to Day 8
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From Day 1 to Day 8
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
All Groups: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Severe Adverse Events (SAEs)
Lasso di tempo: Up to Day 14
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Up to Day 14
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All Groups: Number of Participants With Potentially Clinically Relevant Clinical Laboratory Test Results
Lasso di tempo: Up to Day 8
|
Up to Day 8
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All Groups: Number of Participants With Potentially Clinically Relevant Changes in Vital Signs
Lasso di tempo: Up to Day 8
|
Up to Day 8
|
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All Groups: Number of Participants With Potentially Clinically Relevant Changes in Physical Examination Findings
Lasso di tempo: Up to Day 8
|
Up to Day 8
|
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All Groups: Number of Participants With Potentially Clinically Relevant Changes in 12-lead Electrocardiogram (ECG) Results
Lasso di tempo: Up to Day 8
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Up to Day 8
|
Collaboratori e investigatori
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Metabolismo, errori congeniti
- Malattie genetiche, congenite
- Malattie metaboliche
- Malattie cerebrali, metaboliche, congenite
- Malattie cerebrali, metaboliche
- Metabolismo degli aminoacidi, errori congeniti
- Malattie e anomalie congenite, ereditarie e neonatali
- Malattie nutrizionali e metaboliche
- Fenilchetonuria
Altri numeri di identificazione dello studio
- 359-201-00009
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
Informazioni su farmaci e dispositivi, documenti di studio
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Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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