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An Study to Determine the Bioavailability of E2609 Tablets Compared to Capsules and the Effect of Food on Absorption
A Randomized, Open-label, 3-treatment Crossover Study to Determine the Bioavailability of E2609 Tablets Compared to Capsules and the Effect of Food on Absorption in Healthy Caucasian Male Adults
Lead sponsor
Asset
Elenbecestat
Listed sites
1
Recruiting sites
-
Enrollment
18
actual
Study population
Alzheimer’s disease
Key I/E criteria
•Age 30-55•Male
Primary endpoints
•AUC(0-inf) ratio, new tablet•AUC(0-inf) ratio, fed state•Cmax ratio, new tablet
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Caucasian males defined as persons of a European or Latin American descent
2. Healthy male 30 to 55 years inclusive at the time of informed consent
3. Body mass index (BMI) of 18 to 32 kg/m2 at Screening
4. Subjects must have had a successful vasectomy (confirmed azoospermia), or they and their female partners must not be of childbearing potential or must be practicing highly effective contraception throughout the study period and for 30 days after study drug discontinuation. No sperm donation is allowed during the study period and for 30 days after study drug discontinuation
Exclusion criteria
1. Any history of seizures or epilepsy (not including a history of simple febrile seizures in childhood) or disturbance of consciousness likely to be due to seizures
2. Any medical condition which, in the opinion of the investigator has high risk of seizures (e.g., history of traumatic brain injury associated with loss of consciousness or amnesia, alcohol abuse, substance abuse) at Screening or within past 5 years
3. Any history of cerebrovascular disease (stroke or transient ischemic attack)
4. A history of prolonged QT/QTc interval or prolonged period from the beginning of the QRS complex to the end of the T wave on an ECG (QT)/ QT corrected for heart rate using Fridericia?s formula (QTcF) interval (QTcF \> 450 ms) as demonstrated by the mean of triplicate electrocardiogram (ECGs) (recorded at least 1 min apart) at Screening or Baseline Period
5. Any other clinically significant ECG abnormalities at Screening or Baseline Periods, e.g. component of the ECG cycle from onset of atrial depolarization to onset of ventricular depolarization (PR)\>220 ms, component of ECG wave representing ventricular depolarization (QRS)\>110 ms
6. Hypersensitivity to the study drugs or any of their excipients
Endpoints (5)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Safety / tolerability / PK
5 endpointsAUC(0-inf) ratio, new tablet vs. capsule
Time frame:0 -144 hours
concentration, descriptive
AUC(0-inf) ratio, fed state vs. fasted state, both after administration of new tablet
Time frame:0 - 144 hours
concentration, descriptive
Cmax ratio, new tablet vs. capsule
Time frame:0 - 144 hours
concentration, descriptive
Cmax ratio, fed state vs. fasted state, both after administration of new tablet
Time frame:0 - 144 hours
concentration, descriptive
incidence of Adverse events
Time frame:5.5 weeks
event count, event
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.