- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02217917
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Rivipansel With rHuPH20 in Healthy Subjects
16 juin 2020 mis à jour par: GlycoMimetics Incorporated
A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo Controlled, Single And Multiple Ascending Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Rivipansel (pf 06460031) Following Subcutaneous Administration With Rhuph20 (pf 06744547) In Healthy Subjects
This is a 2 part study designed to provide an initial assessment on the safety, tolerability, and PK of rivipansel, following single ascending (Part 1) and multiple ascending dosing (Part 2) given subcutaneously with rHuPH20, in healthy subjects.
Part 1 of the study will be conducted using a cross-over design while Part 2 of the study will be conducted using a parallel design.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
27
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Brussels, Belgique, B-1070
- Pfizer Clinical Research Unit
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 55 ans (Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive.
- Body Mass Index 17.5 - 30.5 kg/m2 and body weight >50 kg at Screening.
- Normal skin without potentially obscuring features in the area intended for infusion.
- Subjects willing to defer receiving prophylactic immunizations (eg, influenza or pneumococcal vaccines) during the study.
- Evidence of a personally signed and dated informed consent document indicating that the subject or a legally acceptable representative has been informed of all pertinent aspects of the study
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- History of a recent major surgery (within 3 months of screening).
- Serious infection within 1 month of screening.
- Subjects with chronic skin condition that may interfere in the assessment of emergent safety data.
- A positive urine drug screen.
- Known sensitivity to hyaluronidases.
- History of hepatitis or positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C antibodies (HCV).
- Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.
- Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees directly involved in the conduct of the study.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Cohort 1
Single ascending dose in 3 period cross-over design (with optional 4th period)
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Rivipansel administered as a single dose subcutaneously with rHuPH20 in cross-over fashion.
Each subject may receive up to 4 study treatments (placebo and up to 3 doses of rivipansel).
The planned dose levels are 350 mg, 1210 mg, and 4200 mg (these are subject to change based on emerging data).
Matched Placebo administered as single dose subcutaneously with rHuPH20.
Rivipansel administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.
Planned doses are 1400 mg loading and 700 mg maintenance for 12 doses (these are subject to change based on emerging data).
Rivipansel administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.
Planned doses are 2800 mg loading and 1400 mg maintenance for 12 doses (these are subject to change based on emerging data).
Matched Placebo administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.
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Expérimental: Cohort 2
Multiple ascending dose
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Rivipansel administered as a single dose subcutaneously with rHuPH20 in cross-over fashion.
Each subject may receive up to 4 study treatments (placebo and up to 3 doses of rivipansel).
The planned dose levels are 350 mg, 1210 mg, and 4200 mg (these are subject to change based on emerging data).
Matched Placebo administered as single dose subcutaneously with rHuPH20.
Rivipansel administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.
Planned doses are 1400 mg loading and 700 mg maintenance for 12 doses (these are subject to change based on emerging data).
Rivipansel administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.
Planned doses are 2800 mg loading and 1400 mg maintenance for 12 doses (these are subject to change based on emerging data).
Matched Placebo administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.
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Expérimental: Cohort 3
Multiple ascending dose
|
Rivipansel administered as a single dose subcutaneously with rHuPH20 in cross-over fashion.
Each subject may receive up to 4 study treatments (placebo and up to 3 doses of rivipansel).
The planned dose levels are 350 mg, 1210 mg, and 4200 mg (these are subject to change based on emerging data).
Matched Placebo administered as single dose subcutaneously with rHuPH20.
Rivipansel administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.
Planned doses are 1400 mg loading and 700 mg maintenance for 12 doses (these are subject to change based on emerging data).
Rivipansel administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.
Planned doses are 2800 mg loading and 1400 mg maintenance for 12 doses (these are subject to change based on emerging data).
Matched Placebo administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Assessment of adverse events (AEs)
Délai: Baseline up to 7 days of dosing
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Baseline up to 7 days of dosing
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Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG)
Délai: Baseline up to 7 days of dosing
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Baseline up to 7 days of dosing
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Assessment of vital signs (including blood pressure and pulse rate)
Délai: Baseline up to 7 days of dosing
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Baseline up to 7 days of dosing
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Assessment of clinical laboratory tests
Délai: Baseline up to 7 days of dosing
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Baseline up to 7 days of dosing
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Maximum Observed Plasma Concentration (Cmax) for rivipansel following single dose
Délai: Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for rivipansel following single dose
Délai: Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for rivipansel following single dose
Délai: Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for rivipansel following single dose
Délai: Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Dose-Normalized Cmax for rivipansel following single dose
Délai: Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Dose-Normalized AUClast for rivipansel
Délai: Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Dose-Normalized AUCinf for rivipansel
Délai: Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Plasma Decay Half-Life (t1/2) for rivipansel following single dose
Délai: Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Apparent Clearance (CL/F) for rivipansel following single dose
Délai: Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Apparent Volume of Distribution (Vz/F) for rivipansel following single dose
Délai: Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration
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Maximum Observed Plasma Concentration (Cmax) for rivipansel following multiple dose
Délai: Days 1, 7
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Days 1, 7
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for rivipansel following multiple dose
Délai: Days 1, 7
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Days 1, 7
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Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for rivipansel following multiple dose administration, where tau is 12 hours
Délai: Days 1, 7
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Days 1, 7
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Dose-Normalized Cmax for rivipansel following multiple dose administration
Délai: Days 1, 7
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Days 1, 7
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Dose-Normalized AUCtau for rivipansel following multiple dose administration
Délai: Days 1, 7
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Days 1, 7
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Plasma Decay Half-Life (t1/2) for rivipansel following multiple dose
Délai: Day 7
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Day 7
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Minimum Observed Plasma Concentration (Cmin) for rivipansel following multiple dose
Délai: Day 7
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Day 7
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Apparent Clearance (CL/F) for rivipansel following multiple dose
Délai: Day 7
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Day 7
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Peak to Trough Ratio (PTR) of plasma concentration for rivipanselmultiple dose administration
Délai: Day 7
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Day 7
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Accumulation ratio for Area Under the Curve during the dosing interval (Rac) for rivipansel
Délai: Day 7
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Day 7
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 octobre 2015
Achèvement primaire (Réel)
1 avril 2016
Achèvement de l'étude (Réel)
1 avril 2016
Dates d'inscription aux études
Première soumission
13 août 2014
Première soumission répondant aux critères de contrôle qualité
13 août 2014
Première publication (Estimation)
15 août 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
18 juin 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
16 juin 2020
Dernière vérification
1 juin 2020
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- B5201007
- 2014-002748-41 (Numéro EudraCT)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur En bonne santé
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AstraZenecaParexelComplété
Essais cliniques sur Rivipansel
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GlycoMimetics IncorporatedRésiliéDrépanocytose | L'anémie falciforme | Crise vaso-occlusive | Crise de douleur | Troubles drépanocytairesÉtats-Unis, Canada
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GlycoMimetics IncorporatedComplété
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GlycoMimetics IncorporatedComplétéInsuffisance hépatique modérée | Fonction hépatique normaleÉtats-Unis
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GlycoMimetics IncorporatedComplétéEn bonne santé | Insuffisance rénaleÉtats-Unis
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GlycoMimetics IncorporatedComplétéAnémie, DrépanocytoseÉtats-Unis, Canada
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GlycoMimetics IncorporatedComplété
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e-GLORIA trial Protocol Review CommitteeInconnue