Safety and Pharmacokinetics of SNX-001 in Healthy Aged Volunteers
This is a randomised, double-blind, group-sequential, placebo-controlled, safety and pharmacokinetic study in healthy, aged volunteers.
- 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
- to establish SNX-001 pharmacokinetic profile.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase 1 Safety and Pharmacokinetics of Methane Sulfonylfluoride (MSF or SNX-001) After Single and Multiple Oral Dose Administration in Healthy Adult Aged Volunteers|
- Relationship of clinical safety measurements to dose [ Time Frame: Throughout 14-day study period (Days 1, 2, 3, 10, 12, 13, 14) and 7 days after last dose (Day 21) ] [ Designated as safety issue: Yes ]Adverse events (AEs), vital signs, electrocardiogram (ECG), Acetylcholinesterase (AChE) inhibition, laboratory parameters after single and multiple dose administration
- Effect of dose on pharmacokinetic (PK) parameters [ Time Frame: After single (Day 1) and multiple (Day 12) doses ] [ Designated as safety issue: No ]Pharmacokinetic parameters after single and multiple dose administration of SNX-001 (3.6, 7.2 and 10.8 mg)
|Study Start Date:||December 2009|
|Study Completion Date:||August 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
3.6, 7.2, or 10.8 mg single dose or t.i.w.
|Placebo Comparator: Placebo||
Same volumes and frequency as active.
Other Name: Oil vehicle
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.