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NCT05628636
AC-OLE-01-VA Tolerability Study in Healthy Participants Under Different Dosing Conditions
Conditions: Alzheimer Disease
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 18
Sponsor: Cerecin
Location: Australia
Summary
This is an open-label, 3-arm study to compare tolerability of three different titration and dosing schedules of the AC-OLE-01-VA formulation of tricaprilin.Following a screening of up to 28 days, eligible participants will be initially randomised to one of 2 arms (Arm 1 or Arm 2).
Arms 1 and 2 will be completed in advance of Arm 3 with all subsequent participants allocated to Arm 3.
Eligibility Criteria
Inclusion Criteria:Participants who are overtly healthy (in the opinion of the Investigator) as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.Body weight ≥45 kg and body mass index (BMI) within the range 18.0 - 32.0 kg/m2 (inclusive).Exclusion Criteria:History of, or current gastrointestinal (GI) conditions constituting a risk when taking the study treatment; or interfering with the interpretation of data, based on the Investigator's judgement.Participants on a ketogenic diet, low-fat diet or actively using medium chain triglycerides, ketone esters, or other ketogenic products within 3 months prior to screening.
Source: ClinicalTrials.gov (NCT05628636). StuddyBuddy aggregates publicly available trial information.