Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-01-31

Brief Summary

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

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Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dose regimen 1

Varied doses

Group Type EXPERIMENTAL

Velusetrag

Intervention Type DRUG

Capsules

Dose regimen 2

Varied doses

Group Type EXPERIMENTAL

Velusetrag

Intervention Type DRUG

Capsules

Placebo

Matching placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Capsules

Interventions

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Velusetrag

Capsules

Intervention Type DRUG

Velusetrag

Capsules

Intervention Type DRUG

Placebo

Capsules

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes