Phase 1 Type 2 Diabetes Trial, Not Yet Recruiting NCT07511010 Sponsor: Chipscreen Biosciences, Ltd. Condition: Type 2 Diabetes
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Phase 1 Type 2 Diabetes Trial, Not Yet Recruiting

NCT07511010
Not Yet Recruiting Phase 1

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

  • Healthy men or women who are between 18 and 45 years old (inclusive)
  • People with a Body Mass Index (BMI) between 19.0 and 26.0, where men weigh at least 50 kg and women weigh at least 45 kg
  • People who have no plans to become pregnant or donate sperm from the time of signing the consent form until 3 months after the last dose, and who are willing to use effective contraception during that time
  • People who are 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 significant abnormal results on lab tests, or who have a history of significant illness affecting the heart, brain, liver, kidneys, lungs, gut, nerves, blood, immune system, cancer, mental health, or hormones/metabolism
  • People with a known history of severe allergies (such as being allergic to more than 3 things, having allergic asthma, or needing steroid treatment for allergies), or who are known to be allergic 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 gut, liver, or kidney condition in the past 6 months that could affect how drugs are absorbed or processed
  • People who have had surgery in the 3 months before screening, 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 were treated with a significant course of antibiotics for an infection in the 3 months before the first dose, or who have had any infection in the 7 days before the first dose
  • People who have had gut symptoms such as diarrhoea, constipation, nausea, or vomiting in the 7 days before the first dose, which the study doctor considers a reason not to participate
  • 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 the study
  • People with a history of drug or substance misuse, or who test positive for alcohol or drugs on a screening test
  • People who cannot tolerate having blood taken via a needle, or who have a history of fainting in response to needles or blood
  • People whose fasting blood sugar 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 drunk alcohol in the 48 hours before the first dose, or who are unable to avoid alcohol during the study
  • People who smoke more than 5 cigarettes per day within the 3 months before screening, who have smoked in the 48 hours before the first dose, or who are unable to avoid smoking during the study
  • People who regularly drink large amounts of tea, coffee, or other caffeinated drinks in the 3 months before screening, or who have consumed these drinks in the 48 hours before the first dose
  • People who have eaten grapefruit or related citrus fruits (such as Seville oranges or pomelos), star fruit, papaya, pomegranate, or products containing these, in the 14 days before the first dose
  • People whose kidney filtration rate (a measure of kidney function) is below 90 mL/min/1.73 m² (confirm with trial site)
  • People whose blood pressure at screening falls outside acceptable ranges — specifically, a top number below 90 or 140 or above, or a bottom number below 50 or 90 or above (confirm with trial site for exact thresholds)
  • People who are unable to follow a standardised diet for any reason, such as intolerance to high-fat meals or lactose, or who have difficulty swallowing
  • People who plan to do, or are required to do, intense physical exercise during the study
  • People whom the study doctor considers unsuitable to participate for any other reason

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 16 July 2026

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Trial details

Status
Not Yet Recruiting
Phase
Phase 1
Sponsor
Chipscreen Biosciences, Ltd.
Registry
ClinicalTrials.gov
Start date
8 October 2026
Est. completion
26 October 2026

Primary endpoints

FE Study: Maximum plasma concentration (Cmax); FE Study: Area Under the Plasma Concentration-Time Curve (AUC); FE Study: Time to Maximum Plasma Concentration(Tmax); FE Study: Elimination Half-life (t1/2); FE Study: Apparent Total Clearance (CL/F); FE Study: Apparent Volume of Distribution during the terminal phase (Vz/F); Multiple-dose PK study: Maximum plasma concentration (Cmax); Multiple-dose PK Study: Area Under the Plasma Concentration-Time Curve (AUC); Multiple-dose PK Study: Time to Maximum Plasma Concentration(Tmax); Multiple-dose PK Study: steady-state peak concentration (Cmax,ss); Mu...

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: 16 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