Safety and Pharmacokinetics of SNX-001 in Healthy Aged Volunteers

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

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-08-31

Brief Summary

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This is a randomised, double-blind, group-sequential, placebo-controlled, safety and pharmacokinetic study in healthy, aged volunteers.

Objectives:

1. to confirm the previously reported safety profile of oral SNX-001 after single and multiple doses of 3.6, 7.2 or 10.8 mg compared to placebo
2. to establish SNX-001 pharmacokinetic profile.

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Detailed Description

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This study is an exploratory study designed as a group sequential single and multiple escalating dose, double-blind within cohort, randomized, placebo controlled study to investigate the safety and tolerability as well as the pharmacokinetics and pharmacodynamics of SNX-001 given as oral doses in aged volunteers.

Conditions

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Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SNX-001

Group Type EXPERIMENTAL

SNX-001

Intervention Type DRUG

3.6, 7.2, or 10.8 mg single dose or t.i.w.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Same volumes and frequency as active.

Interventions

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SNX-001

3.6, 7.2, or 10.8 mg single dose or t.i.w.

Intervention Type DRUG

Placebo

Same volumes and frequency as active.

Intervention Type DRUG

Other Intervention Names

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methanesulfonyl fluoride MSF Oil vehicle

Eligibility Criteria

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Inclusion Criteria

* Healthy males or females
* Physically and mentally healthy subjects
* Body weight \>60 kg and body weight ≤ 100 kg

Exclusion Criteria

* Evidence of any clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary, haematological, psychiatric, neurological or other significant acute or chronic abnormalities
* History of general malignant diseases
* Evidence of myasthenic weakness
* Acute infection or any other febrile illness

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes