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NCT05028114

NCT05028114
Terminated Phase 1 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You must be between 18 and 65 years old at the time of signing the consent form.
  • You must be considered generally healthy, based on a doctor's review of your medical history, physical exam, blood tests, and heart monitoring.
  • You must weigh at least 45 kg (about 99 lbs) and have a BMI between 18.0 and 32.0.
  • Both men and women are welcome to apply.
  • You must be willing to follow study procedures, including having blood drawn, staying at the clinic for required periods, and following specific meal requirements.
  • You must be a non-smoker or smoke no more than 10 cigarettes per week, and have done so for at least 3 months before your screening appointment.

Who may not be able to join:

  • You may not be eligible if you have a history of, or currently have, stomach or digestive problems that could be risky when taking the study treatment or could affect the study results (confirm with trial site).
  • You may not be eligible if you have taken any over-the-counter or prescription medicines, including herbal supplements, within 7 days before receiving the study treatment — though paracetamol/acetaminophen (up to 2g per day), hormone replacement therapy, and hormonal contraception are allowed.
  • You may not be eligible if you are currently following a ketogenic diet, a low-fat diet, or regularly using products such as medium chain triglycerides, ketone esters, or similar ketogenic supplements.

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.

Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Terminated
Phase
Phase 1
Sponsor
Cerecin
Registry
clinicaltrials_gov
Start date
31 August 2021
Est. completion
18 March 2022

Where this trial is recruiting

🇦🇺 Australia

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Area under the concentration-time curve (AUC) of total ketones (β-hydroxybutyrate and acetoacetate) after single-dose administration of tricaprilin and placebo formulations (Part 1, Part 2); Maximum observed concentration (Cmax) of total ketones (β-hydroxybutyrate and acetoacetate) after single-dose administration of tricaprilin and placebo formulations (Part 1, Part 2); Time of maximum concentration (Tmax) of total ketones (β-hydroxybutyrate and acetoacetate) after single-dose administration of tricaprilin and placebo formulations (Part 1, Part 2)

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: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov