Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects

Alfasigma

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: Placebo; Drug: Velusetrag

Study type: Interventional

Funder types: Industry

Identifiers

NCT01467726

0048

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 65 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 3 patient groups

Dose regimen 1

Experimental group

Description:

Varied doses

Treatment:

Drug: Velusetrag

Drug: Velusetrag

Dose regimen 2

Experimental group

Description:

Varied doses

Treatment:

Drug: Velusetrag

Drug: Velusetrag

Placebo

Experimental group

Description:

Matching placebo

Treatment:

Drug: Placebo