Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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

Key facts

Study ID

NCT01467726

Run by

Alfasigma S.p.A.

People needed

40

Starts

2011-11-01

Expected to finish

2012-01-01

Last updated by the study team

2025-07-08

Who can join

Age: 65 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Comprehensive Clinical Development — Miramar, Florida, United States

Full record on ClinicalTrials.gov

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