Heathly VolunteersPhase 2G-TSPONCT07682233
Role of a Mitochondrial Receptor in Blood Sugar Regulation
A Phase 2 study testing XBD173 in people with Heathly Volunteers, run by Imperial College London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Heathly Volunteers
- What is being tested?
- XBD173
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Mar 2026to 1 Sep 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to 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 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.
Who cannot join
- 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:
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
NIHR Trust Imperial Clinical Research Facility
London, W120NN
Yucen Wu, +44 020 3313 8082, yucen.wu23@imperial.ac.uk
David R Owen
About this study
Official title: 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:
Read more
- 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.
- Conditions
- Heathly Volunteers
- Being tested
- XBD173, Placebo
- Keywords
- TSPO, 18 kDa Translocator Protein, XBD173, Glucose Metabolism, Fasting Plasma Glucose, Oral Glucose Tolerance Test, OGTT, Insulin Response, Resting Energy Expenditure, Respiratory Quotient, Healthy Volunteers, Randomised Controlled Trials, Randomised Crossover Study, Placebo-Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XBD173Drug
Also called Emapunil
90mg XBD173 oral dose
PlaceboDrug
Participants will receive a placebo drug, identical in appearance to XBD173.
| Study group | Role | What they receive |
|---|---|---|
| Acute glucose challenege visits | Experimental | 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. Receives: Drug: XBD173; Drug: Placebo |
| Fasting visits | Experimental | 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. Receives: Drug: XBD173; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Glucose Concentration in millimoles per litre During Oral Glucose Tolerance Test
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.
Measured: 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
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.
Measured: 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.
Secondary outcomes (6)
Plasma Insulin Concentration in milliunits per litre During Oral Glucose Tolerance Test
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.
Measured: 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
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.
Measured: 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
Peripheral endothelial function will be measured using a cuff-based assessment during each study visit and compared between XBD173 and placebo conditions.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
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.
Measured: Adipose tissue biopsy will take place from the first study visit to the fourth visit, at 120 minutes after XBD173/placebo.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start27 Mar 2026
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heathly VolunteersStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07682233
- Sponsor's protocol ID
- 23HH8619
- Other IDs
- 334773, 24/LO/0127
- Acronym
- G-TSPO
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study sponsored by Imperial College London. Researchers will not breach the data violation policy.