- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02998775
Phase 0 Study in Healthy, Hepatic and Renal Impaired Subjects to Obtain Plasma for Lenvatinib Protein Binding
A Multicenter Phase 0 Study In Healthy Subjects and Subjects With Either Hepatic Or Renal Impairment To Obtain Plasma For Assessment In Vitro Lenvatinib Protein Binding
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
E7080-A001-010 is a multicenter, parallel-group study in participants with mild, moderate, or severe hepatic or renal impairment and age-, gender-, and smoking status-matched healthy participants. Approximately 6 participants with each degree (mild, moderate, or severe) of hepatic or renal impairment will be enrolled. Two cohorts of 8 healthy participants will be enrolled. One cohort of healthy participants will be matched to the hepatic-impaired participants, whereas the other will be matched to the renal-impaired participants.
The study has 2 phases. The Pre-study Phase consists of a Screening Period and a Baseline Period. The Study Phase consists of a 2-day Study Period. No lenvatinib will be administered in this study.
The end of the study will be the date of the last study visit for the last participant in the study.
The following estimates are provided:
- From first participant in to last participant out, the study is expected to take approximately one year to complete.
- The maximum estimated duration of the study for each participant is anticipated to be approximately 5 weeks.
Type d'étude
Inscription (Réel)
Phase
- Première phase 1
Contacts et emplacements
Lieux d'étude
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-
Florida
-
Orlando, Florida, États-Unis
- Orlando Clinical Research Center, Inc.
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-
Minnesota
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Minneapolis, Minnesota, États-Unis
- DaVita Clinical Research
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Tennessee
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Knoxville, Tennessee, États-Unis
- New Orleans Center for Clinical Research
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
Key Inclusion Criteria:
- Male or Female
Age, at the time of Informed Consent:
i. Hepatic Impairment Participants (Including Matched Healthy Participants): 18 to 70 years old, inclusive ii. Renal Impairment Participants (Including Matched Healthy Participants): 18 to 79 years old, inclusive
- Non-smokers and smokers who smoke no more than 10 cigarettes per day
- Besides diabetes and, as appropriate, renal or hepatic impairment, participants must have no history of acute or chronic clinically relevant disease or condition, as determined by the investigator.
For participants with hepatic impairment:
- Liver cirrhosis that has been stable;
- Platelet count >30,000 cells/millimeter cubed (mm^3);
- Total score on the Child-Pugh classification system between 5 and 6 (Group 1, mild), 7 and 9 (Group 2, moderate), and 10 and 15 (Group 3, severe)
For healthy participants:
• Creatinine clearance ≥ 81 milliliter per minute (mL/min)
For participants with renal impairment:
- Must have a diagnosis of renal impairment that has been stable
- Must have renal impairment in the following categories based on creatinine clearance values: mild (creatinine clearance, 50 to 80 mL/min), moderate (creatinine clearance, 30 to 49 mL/min), or severe (creatinine clearance, 15 to 29 mL/min) renal impairment
Exclusion Criteria:
Key Exclusion Criteria:
- Use of any new medication
- Human immunodeficiency virus (HIV) positive
- Presence of acute active liver disease or acute liver injury
- History of significant cardiovascular impairment
- Positive drug or alcohol test
- Weight loss or gain of >10% prior to Day 1
- Receipt of blood or blood products or donation of blood or blood products
For participants with hepatic impairment:
- History of hepatic transplant, systemic lupus erythematosus, or hepatic coma
- Received treatment with interferon or pegylated interferon
- Participants who have encephalopathy >Grade 2, sepsis, or gastrointestinal bleeding; esophageal varices >Grade 2, acute hepatic failure of any etiology, history of surgical portosystemic shunt, renal impairment (creatinine clearance <50 mL/min according to the Cockcroft-Gault formula), and rapidly deteriorating hepatic function
- Systolic blood pressure (SBP) ≥ 160 millimeters of mercury (mmHg) and/or diastolic blood pressure (DBP) ≥ 100 mmHg
For healthy participants:
• Hemoglobin level less than 12.0 grams per deciliter (g/dL)
For participants with renal impairment:
- A history of renal transplant
- SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg for participants with mild renal impairment; SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg for participants with moderate and severe renal impairment
- Significant bleeding diathesis
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Autre: 6 participants with mild renal impairment
Renal Impairment Mild: creatinine clearance, 50 to 80 milliliters per minute (mL/min)
|
No lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding.
|
Autre: 6 participants with moderate renal impairment
Renal Impairment Moderate: creatinine clearance, 30 to 49 mL/min
|
No lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding.
|
Autre: 6 participants with severe renal impairment
Renal Impairment Severe: creatinine clearance, 15 to 29 mL/min
|
No lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding.
|
Autre: 8 participants normal renal status
Renal status normal as defined by creatinine clearance ≥ 81 mL/min, otherwise age, gender, and smoking characteristics matching renal-impaired participants
|
No lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding.
|
Autre: 6 participants with mild hepatic impairment
Hepatic impairment mild: total score on the Child-Pugh classification system between 5 and 6
|
No lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding.
|
Autre: 6 participants with moderate hepatic impairment
Hepatic impairment moderate: total score on the Child-Pugh classification system between 7 and 9
|
No lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding.
|
Autre: 6 participants with severe hepatic impairment
Hepatic impairment severe: total score on the Child-Pugh classification system between 10 and 15
|
No lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding.
|
Autre: 8 participants normal hepatic status
Hepatic status normal, otherwise age, gender, and smoking characteristics matching hepatic-impaired participants
|
No lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Number of participants with any serious adverse event and any non-serious adverse event
Délai: 1 week
|
1 week
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- E7080-A001-010
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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