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

Alfasigma S.p.A.1 site in 1 country40 target enrollmentNovember 1, 2011

ConditionsAlzheimer's Disease

InterventionsVelusetrag Placebo

DrugsVelusetrag Placebo

Overview

Phase: Phase 1
Intervention: Velusetrag
Conditions: Alzheimer's Disease
Sponsor: Alfasigma S.p.A.
Enrollment: 40
Locations: 1
Primary Endpoint: Tolerability of repeat dosing of velusetrag
Status: Completed
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

November 1, 2011

End Date

January 1, 2012

Last Updated

9 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Alfasigma S.p.A.

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Dose regimen 1

Varied doses

Intervention: Velusetrag

Dose regimen 2

Varied doses

Intervention: Velusetrag

Placebo

Matching placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Tolerability of repeat dosing of velusetrag

Time Frame: 3 weeks

Number of subjects who complete the treatment period and are not withdrawn due to adverse events (AEs) or clinically significant findings on vital signs or ECGs

Secondary Outcomes

Pharmacodynamic effects of velusetrag(3 weeks)
Profile of urine PK of velusetrag and metabolite(Days 1, 7, 8, 14, 15, 21 0-24h postdose and 24-72 h post Day 21 dose)
Profile of Plasma Pharmacokinetics (PK) of velusetrag and metabolite(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))