Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

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

26. června 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

50

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Spojené království
      • London, Spojené království, W120NN
        • Nábor
        • NIHR Trust Imperial Clinical Research Facility
        • Kontakt:
        • Vrchní vyšetřovatel:
          • David R Owen
        • Dílčí vyšetřovatel:
          • Aaron M Lett

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Základní věda
  • Přidělení: Randomizované
  • Intervenční model: Crossover Assignment
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Lék: XBD173
90mg XBD173 oral dose
Ostatní jména:
  • Emapunil
Lék: Placebo
Participants will receive a placebo drug, identical in appearance to XBD173.
Experimentální: 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.
Lék: XBD173
90mg XBD173 oral dose
Ostatní jména:
  • Emapunil
Lék: Placebo
Participants will receive a placebo drug, identical in appearance to XBD173.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Plasma Glucose Concentration in millimoles per litre During Oral Glucose Tolerance Test
Časové okno: 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
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Plasma Insulin Concentration in milliunits per litre During Oral Glucose Tolerance Test
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Imperial College London

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

27. března 2026

Primární dokončení (Odhadovaný)

1. září 2028

Dokončení studie (Odhadovaný)

1. září 2028

Termíny zápisu do studia

První předloženo

9. června 2026

První předloženo, které splnilo kritéria kontroly kvality

26. června 2026

První zveřejněno (Aktuální)

2. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

2. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

26. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 23HH8619
  • 334773 (Identifikátor registru: Integrated Research Application System (IRAS))
  • 24/LO/0127 (Identifikátor registru: Research Ethics Committee (REC))

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

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

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Heathly Volunteers

Klinické studie na XBD173

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Bahamas

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

3
Předplatit