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

26 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

50

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Regno Unito
      • London, Regno Unito, W120NN
        • Reclutamento
        • NIHR Trust Imperial Clinical Research Facility
        • Contatto:
        • Investigatore principale:
          • David R Owen
        • Sub-investigatore:
          • Aaron M Lett

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: XBD173
90mg XBD173 oral dose
Altri nomi:
  • Emapunil
Droga: Placebo
Participants will receive a placebo drug, identical in appearance to XBD173.
Sperimentale: 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.
Droga: XBD173
90mg XBD173 oral dose
Altri nomi:
  • Emapunil
Droga: Placebo
Participants will receive a placebo drug, identical in appearance to XBD173.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Plasma Glucose Concentration in millimoles per litre During Oral Glucose Tolerance Test
Lasso di tempo: 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
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Plasma Insulin Concentration in milliunits per litre During Oral Glucose Tolerance Test
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Imperial College London

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

27 marzo 2026

Completamento primario (Stimato)

1 settembre 2028

Completamento dello studio (Stimato)

1 settembre 2028

Date di iscrizione allo studio

Primo inviato

9 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

26 giugno 2026

Primo Inserito (Effettivo)

2 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 23HH8619
  • 334773 (Identificatore di registro: Integrated Research Application System (IRAS))
  • 24/LO/0127 (Identificatore di registro: Research Ethics Committee (REC))

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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