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Role of a Mitochondrial Receptor in Blood Sugar Regulation (G-TSPO)

26 juin 2026 mis à jour par: Imperial College London

An Experimental Medicine Study to Investigate the Role of the 18 kiloDalton Translocator Protein in Glucose Metabolism

The goal of this clinical trial is to learn whether a single dose of XBD173, a medicine that binds to a protein called the 18 kiloDalton Translocator Protein (TSPO), affects how the body processes glucose in healthy volunteers aged 18 to 75 years.

The main questions it aims to answer are:

  • Does a single dose of XBD173 change fasting blood glucose levels compared with placebo?
  • Does a single dose of XBD173 change blood glucose levels after participants drink a glucose solution compared with placebo?

Researchers will compare XBD173 with a placebo, which does not contain the active medicine, to see whether activating TSPO affects glucose metabolism in the fasting state and after a glucose drink.

Participants will:

  • Attend a screening visit to confirm eligibility, including a medical history, physical examination and blood tests.
  • Attend four study visits after fasting overnight: two visits involving a glucose drink and two visits without a glucose drink.
  • Receive a single oral dose of XBD173 at some visits and placebo at other visits. The order will be randomised, and neither participants nor the study team conducting the assessments will know which treatment is given during each visit.
  • Have repeated blood samples taken through a cannula to measure glucose, insulin and other markers related to metabolism and inflammation.
  • Have resting energy use measured by breathing under a transparent canopy connected to a standard metabolic measurement device.
  • Have blood pressure, heart rate, height and weight measured.
  • Undergo measurement of blood vessel function using a cuff.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

50

Phase

  • Phase 2

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

Lieux d'étude

  • Royaume-Uni
      • London, Royaume-Uni, W120NN
        • Recrutement
        • NIHR Trust Imperial Clinical Research Facility
        • Contact:
        • Chercheur principal:
          • David R Owen
        • Sous-enquêteur:
          • Aaron M Lett

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
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

Inclusion Criteria:

  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • Aged 18-75 years old
  • A female subject is eligible to participate if she is a) of non-childbearing potential, defined as pre-menopausal females with a documented tubal ligation or hysterectomy, or postmenopausal defined as 12 months of spontaneous amenorrhea or b) of childbearing potential but not pregnant (as determined by urinary pregnancy test on screening and on each study day) and willing to use one of the contraception methods.
  • Male subject must agree to use one of the contraception methods.
  • No history of diabetes.

Exclusion Criteria:

  • Clinically meaningful abnormalities in routine bloods including:

    • eGFR < 60ml/min
    • Elevation of liver enzymes/bilirubin
    • Prolonged prothrombin time
    • Thrombocytopenia

  • Use of the following medications or therapies:

    • P450 CY3A4 inhibitors

      • Potent: Boceprevir, Clarithromycin, Cobicistat, Idelalisib, Itraconazole, Ketoconazole, Nelfinavir, Ritonavir, Saquinavir, Telaprevir, Telithromycin, Voriconazoleb
      • Moderate: Aprepitant, Conivaptan, Crizotinib, Diltiazem, Dronedarone, Erythromycin, Fluconazole, Imatinib, Isavuconazole, Nefazodone, Netupitant, Nilotinib, Posaconazolee, Tofisopam, Verapamil
      • Unclassified: Delavirdine

    • P450 CY3A4 inducers

      • Potent: Carbamazepine, Enzalutamide, Fosphenytoin, Mitotane, Phenytoin, Rifampicin
      • Moderate; Bosentan, Efavirenz, St John's wort
      • Unclassified; Barbiturates, Nevirapine, Primidone, Rifabutin, Rifapentine
    • oral contraceptives
    • oral anticoagulants or antiplatelet agents other than low dose aspirin
    • levothyroxine
  • Currently breastfeeding.
  • Any clinical significant medical conditions that in the opinion of the investigator would compromise subjects' safety or compliance with study procedures.
  • History of any clinical condition which in the opinion of the principal investigator would compromise the scientific integrity of the study, such as some chronic systemic diseases affecting blood, liver or kidneys or endocrine system.
  • Unwillingness or inability to follow the procedures outlined in the protocol.
  • Subject is mentally or legally incapacitated.

  • Contraindication to XBD173 use:

    • Hypersensitivity to the active substance or to any of the excipients

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 croisée
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Acute glucose challenege visits
Participants receive a single oral dose of XBD173 90 mg during one study visit and a placebo during the corresponding crossover visit, before an OGTT. The order of the drug and placebo is randomised.
Médicament: XBD173
90mg XBD173 oral dose
Autres noms:
  • Émapunil
Médicament: Placebo
Participants will receive a placebo drug, identical in appearance to XBD173.
Expérimental: Fasting visits
Participants receive a single oral dose of XBD173 90 mg during one study visit and a placebo during the corresponding crossover visit, with participants remaining fasted. The order of the drug and placebo is randomised.
Médicament: XBD173
90mg XBD173 oral dose
Autres noms:
  • Émapunil
Médicament: Placebo
Participants will receive a placebo drug, identical in appearance to XBD173.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Plasma Glucose Concentration in millimoles per litre During Oral Glucose Tolerance Test
Délai: Blood samples will be collected at 60, 30, and 10 minutes before the oral glucose tolerance test; at the time of the test; and at 30, 60, 90, 120, 150, and 180 minutes after the test. The oral glucose tolerance test will be administered at 0 minutes.
Plasma glucose concentration in millimoles per litre will be measured from venous blood samples during acute glucose challenge visits after administration of XBD173 or placebo. Plasma glucose concentrations at each time point and/or the glucose response over time will be compared between XBD173 and placebo conditions.
Blood samples will be collected at 60, 30, and 10 minutes before the oral glucose tolerance test; at the time of the test; and at 30, 60, 90, 120, 150, and 180 minutes after the test. The oral glucose tolerance test will be administered at 0 minutes.
Fasting Plasma Glucose Concentration in millimoles per litre After XBD173 or Placebo Administration
Délai: Blood samples will be collected at 10 minutes before XBD173 or placebo administration, at administration, and at 30, 60, 90, 120, 150, 180, 210, and 240 minutes after administration.
Fasting plasma glucose concentration in millimoles per litre will be measured from venous blood samples during fasting study visits after administration of XBD173 or placebo. Plasma glucose concentrations at each time point and/or the fasting glucose response over time will be compared between XBD173 and placebo conditions.
Blood samples will be collected at 10 minutes before XBD173 or placebo administration, at administration, and at 30, 60, 90, 120, 150, 180, 210, and 240 minutes after administration.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Plasma Insulin Concentration in milliunits per litre During Oral Glucose Tolerance Test
Délai: Blood samples will be collected at 60, 30, and 10 minutes before the oral glucose tolerance test; at the time of the test; and at 30, 60, 90, 120, 150, and 180 minutes after the test. The oral glucose tolerance test will be administered at 0 minutes.
Plasma insulin concentration in milliunits per litre will be measured from venous blood samples during acute glucose challenge visits after administration of XBD173 or placebo. Plasma insulin concentrations at each time point and/or the glucose response over time will be compared between XBD173 and placebo conditions.
Blood samples will be collected at 60, 30, and 10 minutes before the oral glucose tolerance test; at the time of the test; and at 30, 60, 90, 120, 150, and 180 minutes after the test. The oral glucose tolerance test will be administered at 0 minutes.
Fasting Plasma Insulin Concentration in milliunits per litre After XBD173 or Placebo Administration
Délai: Blood samples will be collected at 10 minutes before XBD173 or placebo administration, at administration, and at 30, 60, 90, 120, 150, 180, 210, and 240 minutes after administration.
Fasting plasma insulin concentration in milliunits per litre will be measured from venous blood samples during fasting study visits after administration of XBD173 or placebo. Plasma insulin concentrations at each time point and/or the fasting glucose response over time will be compared between XBD173 and placebo conditions.
Blood samples will be collected at 10 minutes before XBD173 or placebo administration, at administration, and at 30, 60, 90, 120, 150, 180, 210, and 240 minutes after administration.
Peripheral Endothelial Function Measured by Cuff-Based Assessment
Délai: Assessed at 10 minutes before the oral glucose tolerance test during acute glucose challenge visits, and at 10 minutes before XBD173 or placebo administration during fasting visits.
Peripheral endothelial function will be measured using a cuff-based assessment during each study visit and compared between XBD173 and placebo conditions.
Assessed at 10 minutes before the oral glucose tolerance test during acute glucose challenge visits, and at 10 minutes before XBD173 or placebo administration during fasting visits.
Respiratory Quotient Measured by Indirect Calorimetry (Acute Glucose Challenge)
Délai: Indirect calorimetry will take place from the first study visit to the fourth visit. For acute glucose visits, respiratory quotient will be measured at 140, 90 and 30 minutes prior to OGTT, and 50, 170 minutes after OGTT.
Respiratory quotient will be measured using indirect calorimetry during acute glucose challenge visits and fasting visits after administration of XBD173 or placebo. Respiratory quotient values will be compared between XBD173 and placebo conditions.
Indirect calorimetry will take place from the first study visit to the fourth visit. For acute glucose visits, respiratory quotient will be measured at 140, 90 and 30 minutes prior to OGTT, and 50, 170 minutes after OGTT.
Respiratory Quotient Measured by Indirect Calorimetry (Fasting Visits)
Délai: Indirect calorimetry will take place from the first study visit to the fourth visit. For fasting visits, respiratory quotient will be measured at 30 minutes prior to XBD173/placebo and 50, 110, 170, 230 minutes after XBD173/placebo.
Respiratory quotient will be measured using indirect calorimetry during acute glucose challenge visits and fasting visits after administration of XBD173 or placebo. Respiratory quotient values will be compared between XBD173 and placebo conditions.
Indirect calorimetry will take place from the first study visit to the fourth visit. For fasting visits, respiratory quotient will be measured at 30 minutes prior to XBD173/placebo and 50, 110, 170, 230 minutes after XBD173/placebo.
Adipose Tissue Composition From Subcutaneous Adipose Tissue Biopsy
Délai: Adipose tissue biopsy will take place from the first study visit to the fourth visit, at 120 minutes after XBD173/placebo.
Adipose tissue composition will be measured from subcutaneous adipose tissue samples collected by percutaneous biopsy during study visits after administration of XBD173 or placebo. Adipose tissue composition will be compared between XBD173 and placebo conditions.
Adipose tissue biopsy will take place from the first study visit to the fourth visit, at 120 minutes after XBD173/placebo.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Imperial College London

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)

27 mars 2026

Achèvement primaire (Estimé)

1 septembre 2028

Achèvement de l'étude (Estimé)

1 septembre 2028

Dates d'inscription aux études

Première soumission

9 juin 2026

Première soumission répondant aux critères de contrôle qualité

26 juin 2026

Première publication (Réel)

2 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 23HH8619
  • 334773 (Identificateur de registre: Integrated Research Application System (IRAS))
  • 24/LO/0127 (Identificateur de registre: Research Ethics Committee (REC))

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Study sponsored by Imperial College London. Researchers will not breach the data violation policy.

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

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 .

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