CompletedPhase 1

Single Dose Study of ALZ-801 Prototype Tablets

Four-Period, Single-Dose, Sequential Study in Healthy Adults, to Assess Pharmacokinetics of ALZ-801 and Tramiprosate From ALZ-801 Prototype Tablets and Effect of Food on Bioavailability of ALZ-801 and Tramiprosate for Selected Prototype Tablet

Lead sponsor

Alzheon Inc.

Asset

ALZ-801

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 18-65

Primary endpoints

•Cmax for ALZ-801, tramiprosate, and NRM5074•Tmax for ALZ-801, tramiprosate, and NRM5074•AUC for ALZ-801, tramiprosate, and NRM5074

Identifiers

Registered as

Org study IDALZ-801-104

NCT IDNCT04585347

Timeline

Milestones

Study start2015-09-16actual

Primary completion2015-11-13actual

Study completion2015-11-13actual

Study first posted2020-10-14actual

Last update posted2020-10-14actual

Assets

Drug assets

ALZ-801

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Healthy males and females

•Females must be of non-childbearing potential

•Body mass index (BMI) of 18.0 to 35.0 kg/m2

Exclusion criteria

•History of any drug or alcohol abuse in the past 2 years

•Subjects known to have a creatinine clearance of <60 mL/min

•Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results

•History of cardiovascular, renal, hepatic, neurological, psychiatric, chronic respiratory or gastrointestinal disease as judged by the investigator

Endpoints (7)

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.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

Cmax for ALZ-801, tramiprosate, and NRM5074

Time frame:72 hours after dosing

concentration, descriptive

Primary/protocol endpoint

Tmax for ALZ-801, tramiprosate, and NRM5074

Time frame:72 hours after dosing

concentration, descriptive

Primary/protocol endpoint

AUC for ALZ-801, tramiprosate, and NRM5074

Time frame:72 hours after dosing

concentration, descriptive

Primary/protocol endpoint

Frel for ALZ-801 and tramiprosate

Time frame:72 hours after dosing

concentration, descriptive

Primary/protocol endpoint

Frel (test to literature reference)

Time frame:72 hours after dosing

concentration, descriptive

Secondary/protocol endpoint

Number of participants with adverse events

Time frame:72 hours

event count, event

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

T1/2 for ALZ-801, tramiprosate, and NRM5074

Time frame:72 hours after dosing

concentration, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Hey JA, Yu JY, Versavel M, Abushakra S, Kocis P, Power A, Kaplan PL, Amedio J, Tolar M. Clinical Pharmacokinetics and Safety of ALZ-801, a Novel Prodrug of Tramiprosate in Development for the Treatment of Alzheimer's Disease. Clin Pharmacokinet. 2018 Mar;57(3):315-333. doi: 10.1007/s40262-017-0608-3.
PMID29063518via RESULT

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

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.