- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07608705
A Study to Assess the Effect of HRS-1301 on the Pharmacokinetics of Midazolam and Atorvastatin in Healthy Participants
15 juin 2026 mis à jour par: Shandong Suncadia Medicine Co., Ltd.
An Open-label, Single-arm, Fixed-sequence Phase I Clinical Trial to Evaluate the Effect of HRS-1301 Tablets on the Pharmacokinetics of Midazolam and Atorvastatin Calcium Tablets in Healthy Participants
This phase I study in healthy participants aims to assess the pharmacokinetics of midazolam and atorvastatin when administered alone and in combination with HRS-1301, and to assess the safety of HRS-1301 when administered alone and in combination with midazolam or atorvastatin.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
16
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.
Coordonnées de l'étude
- Nom: Ying Wang
- Numéro de téléphone: +86-0518-82342973
- E-mail: ying.wang.yw30@hengrui.com
Lieux d'étude
-
-
Shandong
-
Jinan, Shandong, Chine, 250012
- Recrutement
- Qilu Hospital of Shandong University
-
Chercheur principal:
- Wei Zhao
-
Contact:
- Wei Zhao
- Numéro de téléphone: +86-0531-88382006
- E-mail: Zhao4wei2@hotmail.com
-
Contact:
- Shuwen Yu
- Numéro de téléphone: +86-0531-82169349
- E-mail: yaoxuebu2012@163.com
-
Chercheur principal:
- Shuwen Yu
-
-
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
- Adulte
Accepte les volontaires sains
Oui
La description
Inclusion Criteria:
- Subjects must be aged ≥ 18 years and ≤ 55 years on the day of signing the informed consent form (ICF);
- At screening, body mass index (BMI) must be ≥ 19.0 kg/m² and < 28 kg/m², with body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females;
- Physical examination, vital signs, electrocardiogram (ECG), posteroanterior and lateral chest X-ray/CT, abdominal ultrasound, and laboratory tests (including complete blood count, blood biochemistry, urinalysis, coagulation function, and thyroid function) were normal or abnormal but of no clinical significance;
- Female participants must not be pregnant or lactating and must have negative pregnancy test results prior to investigational drug administration; participants must have had no unprotected sexual intercourse within two weeks prior to screening; female participants of childbearing potential and male participants with partners of childbearing potential must agree to comply with the contraception requirements for the duration specified in the protocol and have no plans to donate sperm or eggs;
- Subjects who understand the study procedures and methods, voluntarily agree to participate in this trial, and provide written informed consent (ICF).
Exclusion Criteria:
- Subjects with previous medical history or current diagnosis of cardiovascular, respiratory, digestive, urinary, hematological, endocrine, infectious, immunological, malignant neoplastic, neurological, or psychiatric/metabolic disorders/dysfunctions, or any other disease;
- Subjects who have gastrointestinal, hepatic, renal, or other known diseases that may affect drug absorption, distribution, metabolism, or excretion, or that may reduce compliance;
- Subjects who have experienced severe trauma or undergone major surgery within 3 months prior to screening, or who plan to undergo surgery during the trial period;
- Subjects with a history of specific allergies, or with an allergic constitution, or with known hypersensitivity to any component of the investigational drug;
- Subjects who have used any medication within 2 weeks prior to screening, or who are still within 5 half-lives of any medication at the time of screening;
- Subjects who have participated in any other clinical trial of a drug or medical device within 3 months prior to screening, or who are still within 5 half-lives of a prior investigational drug at the time of screening;
- Subjects who have donated blood ≥ 200 mL or experienced significant blood loss (≥ 400 mL) within 4 weeks prior to screening, or who have received a blood transfusion within 8 weeks prior to screening;
- Subjects who have received a live (attenuated) vaccine within 4 weeks prior to screening or plan to receive such a vaccine during the trial period.
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: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: HRS-1301 and Midazolam or Atorvastatin Group
HRS-1301 tablets and Midazolam oral solution or Atorvastatin Calcium tablets, specified dose on specified days.
|
Comprimés HRS-1301.
Atorvastatin Calcium tablets.
Midazolam oral solution.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Maximum observed plasma concentration (Cmax)
Délai: Up to 15 days.
|
Plasma pharmacokinetics (PK) parameters of Midazolam when administered alone and in combination with HRS-1301 tablets.
|
Up to 15 days.
|
|
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-last)
Délai: Up to 15 days.
|
Plasma pharmacokinetics (PK) parameters of Midazolam when administered alone and in combination with HRS-1301 tablets.
|
Up to 15 days.
|
|
Area under the plasma concentration-time curve from time 0 to infinity (AUC 0-inf)
Délai: Up to 15 days.
|
Plasma pharmacokinetics (PK) parameters of Midazolam when administered alone and in combination with HRS-1301 tablets.
|
Up to 15 days.
|
|
Maximum observed plasma concentration (Cmax)
Délai: Up to 18 days.
|
Plasma pharmacokinetics (PK) parameters of Atorvastatin when administered alone and in combination with HRS-1301 tablets.
|
Up to 18 days.
|
|
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-last)
Délai: Up to 18 days.
|
Plasma pharmacokinetics (PK) parameters of Atorvastatin when administered alone and in combination with HRS-1301 tablets.
|
Up to 18 days.
|
|
Area under the plasma concentration-time curve from time 0 to infinity (AUC 0-inf)
Délai: Up to 18 days.
|
Plasma pharmacokinetics (PK) parameters of Atorvastatin when administered alone and in combination with HRS-1301 tablets.
|
Up to 18 days.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time to reach maximum observed concentration (Tmax)
Délai: Up to 15 days.
|
Plasma pharmacokinetics (PK) parameters of Midazolam and 1-hydroxymidazolam when administered alone and in combination with HRS-1301 tablets.
|
Up to 15 days.
|
|
Terminal elimination half-life (t1/2)
Délai: Up to 15 days.
|
Plasma pharmacokinetics (PK) parameters of Midazolam and 1-hydroxymidazolam when administered alone and in combination with HRS-1301 tablets.
|
Up to 15 days.
|
|
Apparent clearance (CL/F)
Délai: Up to 15 days.
|
Plasma pharmacokinetics (PK) parameters of Midazolam and 1-hydroxymidazolam when administered alone and in combination with HRS-1301 tablets.
|
Up to 15 days.
|
|
Apparent volume of distribution (Vz/F)
Délai: Up to 15 days.
|
Plasma pharmacokinetics (PK) parameters of Midazolam 1-hydroxymidazolam when administered alone and in combination with HRS-1301 tablets.
|
Up to 15 days.
|
|
Maximum observed plasma concentration (Cmax)
Délai: Up to 15 days.
|
Plasma pharmacokinetics (PK) parameters of 1-hydroxymidazolam following administration of midazolam alone and in combination with HRS-1301 tablets.
|
Up to 15 days.
|
|
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-last)
Délai: Up to 15 days.
|
Plasma pharmacokinetics (PK) parameters of 1-hydroxymidazolam following administration of midazolam alone and in combination with HRS-1301 tablets.
|
Up to 15 days.
|
|
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)
Délai: Up to 15 days.
|
Plasma pharmacokinetics (PK) parameters of 1-hydroxymidazolam following administration of midazolam alone and in combination with HRS-1301 tablets.
|
Up to 15 days.
|
|
Apparent volume of distribution (Vz/F)
Délai: Up to 18 days.
|
Plasma pharmacokinetics (PK) parameters of Atorvastatin and 2-Hydroxy Atorvastatin when administered alone and in combination with HRS-1301 tablets.
|
Up to 18 days.
|
|
Apparent clearance (CL/F)
Délai: Up to 18 days.
|
Plasma pharmacokinetics (PK) parameters of Atorvastatin and 2-Hydroxy Atorvastatin when administered alone and in combination with HRS-1301 tablets.
|
Up to 18 days.
|
|
Time to reach maximum observed concentration (Tmax)
Délai: Up to 18 days.
|
Plasma pharmacokinetics (PK) parameters of Atorvastatin 2-Hydroxy Atorvastatin when administered alone and in combination with HRS-1301 tablets.
|
Up to 18 days.
|
|
Terminal elimination half-life (t1/2)
Délai: Up to 18 days.
|
Plasma pharmacokinetics (PK) parameters of Atorvastatin and 2-Hydroxy Atorvastatin when administered alone and in combination with HRS-1301 tablets.
|
Up to 18 days.
|
|
Maximum observed plasma concentration (Cmax)
Délai: Up to 18 days.
|
Plasma pharmacokinetics (PK) parameters of 2-Hydroxy Atorvastatin following administration of atorvastatin alone and in combination with HRS-1301 tablets.
|
Up to 18 days.
|
|
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-last)
Délai: Up to 18 days.
|
Plasma pharmacokinetics (PK) parameters of 2-Hydroxy Atorvastatin following administration of atorvastatin alone and in combination with HRS-1301 tablets.
|
Up to 18 days.
|
|
Area under the plasma concentration-time curve from time 0 to infinity (AUC 0-inf)
Délai: Up to 18 days.
|
Plasma pharmacokinetics (PK) parameters of 2-Hydroxy Atorvastatin following administration of atorvastatin alone and in combination with HRS-1301 tablets.
|
Up to 18 days.
|
|
Incidence and severity of adverse events (AEs)
Délai: Up to 22 days.
|
Safety and Tolerability.
|
Up to 22 days.
|
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 (Réel)
8 juin 2026
Achèvement primaire (Estimé)
1 août 2026
Achèvement de l'étude (Estimé)
1 août 2026
Dates d'inscription aux études
Première soumission
20 mai 2026
Première soumission répondant aux critères de contrôle qualité
20 mai 2026
Première publication (Réel)
27 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
16 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
15 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies métaboliques
- Dyslipidémies
- Troubles du métabolisme lipidique
- Maladies nutritionnelles et métaboliques
- Hyperlipidémies
- Composés hétérocycliques, 1 anneau
- Composés hétérocycliques
- Composés hétérocycliques, 2 anneaux
- Composés hétérocycliques, anneau fusionné
- Acides gras
- Lipides
- Azoles
- Benzazépines
- Pyrroles
- Acides heptanoïques
- Benzodiazépines
- Atorvastatine
- Midazolam
Autres numéros d'identification d'étude
- HRS-1301-105
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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