- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02571192
A Study to Investigate How the Study Drug SHP626 is Eliminated From the Body After One Dose
30 avril 2019 mis à jour par: Mirum Pharmaceuticals, Inc.
A Phase 1, Open-label Study to Investigate the Absorption, Distribution, Metabolism, and Excretion of [14C]-SHP626 Following a Single Oral Dose in Healthy Male Subjects
The purpose of this study is to determine how SHP626 is absorbed and excreted from the body in healthy males.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
8
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
-
-
Wisconsin
-
Madison, Wisconsin, États-Unis, 53704
- Covance Madison Clinical Research Unit
-
-
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 50 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Homme
La description
Inclusion Criteria:
- Age between 18 and 50 years, inclusive, at the time of consent.
- Must be considered healthy. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, thyroid panel (includes T3, T4 and TSH at Screening only), blood chemistry, coagulation and urinalysis
- Must have a body mass index between 18.0-30.0kg/m² inclusive with a body weight >50 kg (110 lbs).
- Ability to swallow all investigational product.
- A minimum of 1 bowel movement per day.
Exclusion Criteria:
- History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, gallbladder removal, gastric bypass surgery, ileal resection, any small intestinal resection,or current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments.
- Current or relevant history of physical or psychiatric illness.
- Known or suspected intolerance or hypersensitivity to the investigational product, or closely-related compounds, or any of the stated ingredients.
- Significant illness, as judged by the investigator, within 2 weeks of the dose of investigational product.
- Known history of alcohol or other substance abuse within the last year.
- Donation of blood or blood products (eg, plasma or platelets) within 60 days prior to the dose of investigational product.
Within 30 days prior to the dose of investigational product:
- Have used an investigational product (if elimination half-life is <6 days, otherwise 5 half-lives).
- Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this Shire-sponsored study.
- Have had any substantial changes in eating habits, as assessed by the investigator.
- Confirmed systolic blood pressure >139mmHg or <89mmHg, and diastolic blood pressure >89mmHg or <49mmHg.
- Twelve-lead ECG demonstrating QTc >450 msec at screening. If QTc exceeds 450msec, the ECG should be repeated 2 more times and the average of the 3 QTc values should be used to determine the subject's eligibility.
- A positive screen for drugs of abuse at Screening or a positive screen for alcohol or drugs of abuse at Check-in (Day -1).
- Male subjects who consume more than 21 units of alcohol per week or 3 units of alcohol per day.
- A positive human immunodeficiency virus antibody screen, hepatitis B surface antigen, or hepatitis C virus antibody screen.
- Use of tobacco in any form
- Routine consumption of more than 2 units of caffeine per day
- Current use of any medication including over-the-counter, herbal, or homeopathic preparations
- An inability to follow a standardized diet and meal schedule or inability to fast
- Have participated in a [14C]-study within the last 6 months prior to the dose of investigational product.
- Exposure to clinically significant radiation within 12 months prior to the dose of investigational product
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: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Experimental Drug
single oral dose radiolabelled 50mg of SHP626
|
single oral dose 50mg SHP626 with approximately 5.95 μCi RAD
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Pharmacokinetic parameters will be determined from the plasma and blood concentration time data of total radioactivity and from the plasma concentration-time data for SHP626 by non-compartmental analysis.
Délai: Day 1 to day 10
|
Day 1 to day 10
|
Total radioactivity (RAD) in whole blood and plasma
Délai: Day 1 to day 10
|
Day 1 to day 10
|
To determine the total RAD in urine and feces.
Délai: Day 1 to day 10
|
Day 1 to day 10
|
Maximum plasma concentration (Cmax) of 50mg [14C]-SHP626 and RAD occurring at time of maximum observed concentration (tmax)
Délai: Day 1 to day 10
|
Day 1 to day 10
|
Area under the plasma concentration curve (AUC0-t) of 50mg [14C]-SHP626 and RAD from the time of dosing to the last measurable concentration
Délai: Day 1 to Day 10
|
Day 1 to Day 10
|
Area under the plasma concentration curve (AUC0-∞ ) of 50mg [14C]-SHP626 and RAD extrapolated to infinity, calculated using the observed value of the last non-zero plasma concentration
Délai: Day 1 to Day 10
|
Day 1 to Day 10
|
First order rate constant associated with the terminal portion of the plasma curve terminal half-life (t½) for 50mg [14C]-SHP626 and RAD
Délai: Day 1 to Day 10
|
Day 1 to Day 10
|
Total body clearance (CL/F ) of 50mg [14C]-SHP626 and RAD for extravascular administration divided by the fraction of dose absorbed
Délai: Day 1-10
|
Day 1-10
|
Volume of distribution (Vz/F ) of 50mg [14C]-SHP626 and RAD associated with the terminal slope following extra-vascular administration divided by the fraction of dose absorbed
Délai: Day 1-10
|
Day 1-10
|
Cumulative amount (Aef )of RAD recovered in stool over the dosing interval
Délai: Day 1-10
|
Day 1-10
|
Excreted Percent of RAD recovered in stool over the dosing interval
Délai: Day 1-10
|
Day 1-10
|
Cumulative amount (Aeu ) of RAD recovered in urine over the dosing interval
Délai: Day 1-10
|
Day 1-10
|
Excreted Percent of RAD recovered in urine over the dosing interval
Délai: Day 1-10
|
Day 1-10
|
Renal Clearance (CLR ) of 50mg [14C]-SHP626
Délai: Day 1 -10
|
Day 1 -10
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Characterize and identify metabolites of [14C]-SHP626 in plasma by accelerator mass spectrometry for radioactivity quantification
Délai: Day 1 to day 10
|
Metabolites in the excreta and/or plasma will then be structurally identified by a combination of techniques such as co-chromatography with authentic reference standards, high performance liquid chromatography-mass spectrometry, and other spectroscopic techniques if necessary
|
Day 1 to day 10
|
Characterize and identify metabolites of [14C]-SHP626 in urine by accelerator mass spectrometry for radioactivity quantification
Délai: Day 1 to day 10
|
Metabolites in the excreta and/or plasma will then be structurally identified by a combination of techniques such as co-chromatography with authentic reference standards, high performance liquid chromatography-mass spectrometry, and other spectroscopic techniques if necessary
|
Day 1 to day 10
|
Characterize and identify metabolites of [14C]-SHP626 in feces by liquid scintillation counting
Délai: Day 1 to day 10
|
Metabolites in the excreta and/or plasma will then be structurally identified by a combination of techniques such as co-chromatography with authentic reference standards, high performance liquid chromatography-mass spectrometry, and other spectroscopic techniques if necessary
|
Day 1 to day 10
|
Assess the safety and tolerability of [14C]-SHP626 by adverse events (AEs) defined as changes, including changes from baseline in physical examination findings
Délai: Screening to day 7
|
AEs will be coded using the agreed upon version of MedDRA.
The number of events, incidence, and percentage of TEAEs will be calculated overall, by system organ class and by preferred term.
TEAEs will be further summarized by severity and relationship to investigational product.
AEs related to investigational product, AEs leading to withdrawal, SAEs, and deaths will be similarly summarized/listed.
|
Screening to day 7
|
Changes from baseline in vital signs
Délai: Screening to day 7
|
Screening to day 7
|
|
Changes from baseline in ECGs
Délai: Screening to day 7
|
Screening to day 7
|
|
Changes from baseline in hematology
Délai: Screening to day 7
|
Screening to day 7
|
|
Changes from baseline in coagulation
Délai: Screening to day 7
|
Screening to day 7
|
|
Changes in baseline in urinalysis
Délai: Screening to day 7
|
Screening to day 7
|
|
Changes in baseline in chemistry
Délai: Screening to day 7
|
Screening to day 7
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Nicholas Siebers, MD, Covance Clinical Pharmacology
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
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 octobre 2015
Achèvement de l'étude (Réel)
1 octobre 2015
Dates d'inscription aux études
Première soumission
30 septembre 2015
Première soumission répondant aux critères de contrôle qualité
6 octobre 2015
Première publication (Estimation)
8 octobre 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
1 mai 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
30 avril 2019
Dernière vérification
1 avril 2019
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SHP626-102
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 Stéatohépatite non alcoolique
-
Université Catholique de LouvainSuspenduSourd non parlant, non classé ailleursBelgique
-
Universidad Autonoma de MadridActif, ne recrute pasFracture non syndiquéFrance, Espagne, Allemagne, Italie
-
National Institute on Aging (NIA)RecrutementVolontaires en bonne santé | Non sain/non fragile | FrêleÉtats-Unis
-
Histograft Co., Ltd.S. M. Kirov Military Medical Academy of the Ministry of Defense of the Russian...InconnueFracture non syndiqué | Non-union de l'articulation de la cheville sans infectionFédération Russe
-
Stanford UniversityNational Institutes of Health (NIH); AmgenComplétéLymphome non hodgkinien | Lymphomes : non hodgkiniens | Lymphomes : lymphocytes T périphériques non hodgkiniens | Lymphomes : lymphome cutané non hodgkinien | Lymphomes : non hodgkiniens diffus à grandes cellules B | Lymphomes : folliculaires non hodgkiniens/cellules B indolentes | Lymphomes... et d'autres conditionsÉtats-Unis
-
Rutgers, The State University of New JerseyComplétéMBSR-STIM | PMR-STEM | MBSR-NON-STEM | PMR -NON STEMÉtats-Unis
-
Indonesia UniversityInconnueFracture non syndiqué | Défaut fibreux métaphysaireIndonésie
-
Western Regional Medical CenterRésiliéCancer du poumon non à petites cellules non épidermoïde non métastatique | Cancer du poumon non à petites cellules non métastatique à cellules squameusesÉtats-Unis
-
Peking University First HospitalMerck Sharp & Dohme LLCPas encore de recrutementCancer du poumon non à petites cellules non épidermoïde avancé | Cancer du poumon non à petites cellules métastatique non épidermoïde | Cancer du poumon non épidermoïde non à petites cellules récurrentChine
-
Navamindradhiraj UniversityActif, ne recrute pasEnlèvement du tissu fibrosynovial | Non-élimination du tissu fibrosynovial | Rotulien non resurfaçantThaïlande
Essais cliniques sur SHP626
-
Mirum Pharmaceuticals, Inc.RésiliéStéatohépatite non alcooliqueÉtats-Unis, Royaume-Uni, Canada, Porto Rico
-
Mirum Pharmaceuticals, Inc.ComplétéStéatohépatite non alcooliqueÉtats-Unis
-
Mirum Pharmaceuticals, Inc.RecrutementCholangite sclérosante primitiveÉtats-Unis, Royaume-Uni, Israël, Allemagne, Canada
-
Mirum Pharmaceuticals, Inc.RésiliéCholestase intrahépatique de la grossesseÉtats-Unis, Royaume-Uni, Nouvelle-Zélande
-
Mirum Pharmaceuticals, Inc.Complété
-
Mirum Pharmaceuticals, Inc.RecrutementCholangite biliaire primitive | CBPÉtats-Unis, Royaume-Uni, Israël, Allemagne, Italie, France