- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02168803
A Study of Evacetrapib in Participants With Abnormal Cholesterol
A Phase 1b Study to Characterize the Pharmacokinetics of Evacetrapib and Potential for Accumulation After Dosing for 12, 24, and 52 Weeks
The main purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it when given once a day for 12, 24, and 52 weeks to participants with abnormal amounts of cholesterol and/or fat in the blood stream. Information about any side effects that may occur will also be collected.
This study will also evaluate how the study drug reacts in the body when given once a day for 12, 24 and 52 weeks and how the body responds and returns to normal when the treatment is complete. The relationship between study drug and the results from the how the study drug reacts in the body may be explored, if needed.
Aperçu de l'étude
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Florida
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Daytona Beach, Florida, États-Unis, 32117
- Covance Clinical Research Inc
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Texas
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Dallas, Texas, États-Unis, 75247
- Covance
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Wisconsin
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Madison, Wisconsin, États-Unis, 53704
- Covance Clinical Research Inc
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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:
Generally healthy participants or have stable medical conditions that, in the investigator's opinion, will not significantly alter the disposition of the drug, will not place the participant at increased risk by participating in the study, and will not interfere with interpretation of the data and meets one of the following criteria:
- Elevated low-density lipoprotein cholesterol (LDL-C) greater than 100 milligrams per deciliter (mg/dL), OR
- Low high-density lipoprotein cholesterol (HDL-C) less than 45 mg/dL (men); less than 50 mg/dL (women), OR
- Hypercholesterolemia on stable statin therapy for at least 3 month
- Have a body mass index (BMI) of 18 to 37 kilograms per square meter (kg/m^2), inclusive, at screening
Exclusion Criteria:
- Have known allergies or intolerance to evacetrapib, related compounds
- Have history of recurrent rashes or chronic skin conditions
- Have significant history of or current chronic, active inflammatory conditions
- Have history or current evidence of significant neurological disorder
- Have long-standing diabetes that is insulin requiring
- Have history of or current symptoms of malabsorption syndromes, history of gastric bypass surgery
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Evacetrapib: Single Dose
Single oral dose of evacetrapib on Day 1
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Administré par voie orale
Autres noms:
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Expérimental: Evacetrapib: Multiple Dose 12 Weeks
Evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks
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Administré par voie orale
Autres noms:
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Expérimental: Evacetrapib: Multiple Dose 24 Weeks
Evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks
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Administré par voie orale
Autres noms:
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Expérimental: Evacetrapib: Multiple Dose 52 Weeks
Evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks
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Administré par voie orale
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Pharmacokinetics (PK) Parameters of Evacetrapib: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast])
Délai: Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose
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Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose
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PK Parameters of Evacetrapib: Maximum Concentration (Cmax)
Délai: Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose
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Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose
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PK Parameters of Evacetrapib: Terminal Half-life
Délai: Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose
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Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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PD Parameters of Evacetrapib: High Density Lipoprotein Cholesterol (HDL-C) Level
Délai: Day -1, Day 8
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Day -1, Day 8
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PD Parameters of Evacetrapib: Low-Density Lipoprotein Cholesterol (LDL-C) Level
Délai: Day -1, Day 8
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Day -1, Day 8
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PD Parameters of Evacetrapib: Total Cholesterol Level
Délai: Day -1, Day 8
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Day -1, Day 8
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PD Parameters of Evacetrapib: Triglyceride Level
Délai: Day -1, Day 8
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Day -1, Day 8
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 15340
- I1V-MC-EIBM (Autre identifiant: Eli Lilly and Company)
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Essais cliniques sur Evatétrapib
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Eli Lilly and CompanyComplétéVolontaires en bonne santéRoyaume-Uni