Recruiting PHASE2 Heathly Volunteers

New treatment option for Heathly Volunteers

Official title Role of a Mitochondrial Receptor in Blood Sugar Regulation

ClinicalTrials.gov ID: NCT07682233

What this study is testing

What is XBD173?

XBD173 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for heathly volunteers.

Also referred to as Emapunil.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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?
  • Phase 2: a mid-size study of how well it works
  • You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 75. Healthy volunteers may be eligible.

You may be able to join if

  • 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...
  • Male subject must agree to use one of the contraception methods.
  • No history of diabetes.

You likely can't join if

  • 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:
See the full eligibility criteria
Who can join
  • 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...
  • Male subject must agree to use one of the contraception methods.
  • No history of diabetes.
What rules you out
  • 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 people' 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...
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • London, United Kingdom

Compensation & support

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.