- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 1
Kontakte und Standorte
Studienkontakt
- Name: Otsuka Call Center
- Telefonnummer: 844-687-8522
- E-Mail: Otsuka-ProfessionalServices@otsuka-us.com
Studienorte
-
-
Florida
-
Miami, Florida, Vereinigte Staaten, 33014
- Rekrutierung
- Panax Clinical Research
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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
Andere Namen:
|
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Experimental: 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
Andere Namen:
|
|
Experimental: 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
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: From Day 1 to Day 8
|
From Day 1 to Day 8
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
All Groups: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Severe Adverse Events (SAEs)
Zeitfenster: 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
Zeitfenster: Up to Day 8
|
Up to Day 8
|
|
All Groups: Number of Participants With Potentially Clinically Relevant Changes in Vital Signs
Zeitfenster: Up to Day 8
|
Up to Day 8
|
|
All Groups: Number of Participants With Potentially Clinically Relevant Changes in Physical Examination Findings
Zeitfenster: Up to Day 8
|
Up to Day 8
|
|
All Groups: Number of Participants With Potentially Clinically Relevant Changes in 12-lead Electrocardiogram (ECG) Results
Zeitfenster: Up to Day 8
|
Up to Day 8
|
Mitarbeiter und Ermittler
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Gehirns
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Stoffwechsel, angeborene Fehler
- Genetische Krankheiten, angeboren
- Stoffwechselerkrankungen
- Gehirnerkrankungen, Stoffwechselerkrankungen, angeboren
- Gehirnerkrankungen, Stoffwechsel
- Aminosäurestoffwechsel, angeborene Fehler
- Angeborene, erbliche und neonatale Krankheiten und Anomalien
- Ernährungs- und Stoffwechselerkrankungen
- Phenylketonurien
Andere Studien-ID-Nummern
- 359-201-00009
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
IPD-Sharing-Zeitrahmen
IPD-Sharing-Zugriffskriterien
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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