NCT01269476

Safety and Pharmacokinetics of SNX-001 in Healthy Aged Volunteers

Phase 1 Safety and Pharmacokinetics of Methane Sulfonylfluoride (MSF or SNX-001) After Single and Multiple Oral Dose Administration in Healthy Adult Aged Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: SeneXta Therapeutics SA · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Safety

Interventions

Type	Name	Description
DRUG	SNX-001	3.6, 7.2, or 10.8 mg single dose or t.i.w.
DRUG	Placebo	Same volumes and frequency as active.

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-06-01
• Completion: 2010-08-01
• First posted: 2011-01-04
• Last updated: 2011-01-04

Locations

1 site across 1 country: Germany