Type 2 Diabetes Trial, Not Yet Recruiting NCT07519265 Sponsor: Chipscreen Biosciences, Ltd. Condition: Type 2 Diabetes
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Type 2 Diabetes Trial, Not Yet Recruiting

NCT07519265
Not Yet Recruiting Not Applicable

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • Participants must be healthy men or women.
  • Participants must be between 18 and 45 years of age (inclusive).
  • Participants must have a Body Mass Index (BMI) between 19.0 and 26.0, and men must weigh at least 50 kg while women must weigh at least 45 kg.
  • Participants must have no plans for pregnancy or sperm donation from the time of signing the consent form until 3 months after the last dose, and must be willing to use effective contraception during that time.
  • Participants must be willing to take part in the study voluntarily and sign a consent form.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who have any significant abnormal results on lab tests, or a history of significant illness affecting the heart, brain, liver, kidneys, lungs, stomach or bowels, nervous system, blood, immune system, cancer, mental health, or hormones and metabolism.
  • People who have a history of severe allergies (such as allergies to more than 3 things, allergies that affect breathing like asthma, or allergies that needed steroid treatment), or a known allergy to any ingredient in the study drug.
  • People who have had surgery that could affect how a drug moves through the body (such as partial stomach removal), or who have had a stomach, liver, or kidney condition in the past 6 months that could affect how drugs are processed.
  • People who have had surgery in the 3 months before the screening visit, or who have surgery planned during the study.
  • People who have received any vaccine in the month before screening, or who plan to receive a vaccine during the study.
  • People who had an infection requiring significant antibiotic treatment in the 3 months before the first dose, or any infection in the 7 days before the first dose.
  • People who have had stomach or bowel symptoms such as diarrhoea, constipation, nausea, or vomiting in the 7 days before the first dose, which the study doctor considers unsuitable for participation.
  • People who have used any prescription medicines, over-the-counter medicines, or herbal medicines in the month before the first dose, or who have used vitamin supplements in the 2 weeks before joining.
  • People who have a history of drug or substance abuse, or who test positive for alcohol or drugs on a screening test.
  • People who cannot tolerate having blood drawn from a vein, or who have a history of fainting in response to needles or blood.
  • People whose fasting blood sugar level is above 6.1 mmol/L or below 3.9 mmol/L at screening, or who have a history of low blood sugar or fainting related to blood sugar.
  • People who have taken part in any other interventional clinical trial in the 3 months before screening.
  • People who have donated blood or lost more than 200 mL of blood in the 3 months before screening.
  • Women who are pregnant or breastfeeding.
  • People who have consumed more than 14 units of alcohol per week in the 3 months before screening, who have consumed alcohol within 48 hours before the first dose, or who are unable to avoid alcohol during the study.
  • People who have smoked more than 5 cigarettes per day in the 3 months before screening, who have smoked within 48 hours before the first dose, or who are unable to avoid smoking during the study.
  • People who have consumed excessive amounts of tea, coffee, or caffeinated drinks daily in the 3 months before screening, or who have had such drinks within 48 hours before the first dose.
  • People who have eaten grapefruit, Seville oranges, pomelos, star fruit, papaya, pomegranate, or any products containing these fruits within 14 days before the first dose.
  • People whose kidney filtration rate (a measure of kidney function) is below 90 mL/min/1.73 m².
  • People whose blood pressure at screening falls outside the accepted range — specifically, a top number below 90 or at or above 140, or a bottom number below 50 or at or above 90 (confirm with trial site for exact values).
  • People who test positive at screening for HIV, syphilis, Hepatitis B, or Hepatitis C.
  • People who are unable to follow the required study diet — for example, those who cannot tolerate a high-fat meal or who have lactose intolerance — or who have difficulty swallowing.
  • People who plan to do, or are required to do, strenuous physical activity or exercise during the study.
  • People who have any other condition that the study doctor believes makes them unsuitable for the trial.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

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Trial details

Status
Not Yet Recruiting
Phase
Not Applicable
Sponsor
Chipscreen Biosciences, Ltd.
Registry
ClinicalTrials.gov
Start date
9 July 2026
Est. completion
10 August 2026

This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.

Primary endpoints

Maximum plasma concentration (Cmax); Area Under the Plasma Concentration-Time Curve from time zero to the last measurable concentration (AUC0-last); Area Under the Plasma Concentration-Time Curve from time zero to infinity (AUC0-∞)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov