CompletedPhase 1

Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects

A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Study of Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects

Lead sponsor

Alfasigma S.p.A.

Asset

Velusetrag

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 65-85

Primary endpoint

•Tolerability of repeat dosing of velusetrag

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

Org study ID0048

NCT IDNCT01467726

Timeline

Milestones

Study start2011-11 (month precision)

Study first posted2011-11-09estimated

Primary completion2012-01actual (month precision)

Study completion2012-01actual (month precision)

Last update posted2025-07-08actual

Assets

Drug assets

Velusetrag

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age65 Years

Maximum age85 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

• Is in reasonably good health as determined by the investigator based on a detailed medical history, full physical examination (PE), vital signs (VS) (including blood pressure and pulse rate measurement), 12-lead ECG, and clinical laboratory tests.

•Subjects with mild, chronic, stable disease (e.g., controlled hypertension, controlled hypercholesterolemia, non-insulin dependent diabetes, osteoarthritis) may be enrolled if well controlled and not anticipated to interfere with the objectives of the study.

•Mild deviations from normal limits in PE, VS, ECG parameters, lab tests are acceptable if associated with the stable condition or are age-related

Exclusion criteria

•Has a condition, which in the opinion of the investigator, would confound or interfere with evaluation of safety and tolerability or PK or PD of the investigational drug, or prevent compliance with the protocol

Endpoints (4)

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

2 endpoints

Primary/protocol endpoint

Tolerability of repeat dosing of velusetrag

Time frame:3 weeks

event count, event

Secondary/protocol endpoint

Profile of Plasma Pharmacokinetics (PK) of velusetrag and metabolite

Time frame:Days 1, 7, 8, 14, 15, 21 at predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose and 24 hours postdose (and 48 and 72 h post Day 21 dose)

concentration, descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Profile of urine PK of velusetrag and metabolite

Time frame:Days 1, 7, 8, 14, 15, 21 0-24h postdose and 24-72 h post Day 21 dose

descriptive

Secondary/protocol endpoint/low confidence

Pharmacodynamic effects of velusetrag

Time frame:3 weeks

event count, event

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.