Safety and Pharmacokinetics of SNX-001 in Healthy Aged Volunteers

SeneXta Therapeutics

Status and phase: Completed; Phase 1

Conditions: Safety

Treatments: Drug: Placebo; Drug: SNX-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT01269476

SNX-001-PH1-09

2009-011335-13 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 27 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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27 participants in 2 patient groups, including a placebo group

SNX-001

Experimental group

Treatment:

Drug: SNX-001

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo