Safety and Pharmacokinetics of SNX-001 in Healthy Aged Volunteers
|ClinicalTrials.gov Identifier: NCT01269476|
Recruitment Status : Completed
First Posted : January 4, 2011
Last Update Posted : January 4, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Safety||Drug: SNX-001 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||August 2010|
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
- 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) ]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 ]Pharmacokinetic parameters after single and multiple dose administration of SNX-001 (3.6, 7.2 and 10.8 mg)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01269476
|Scope Life Sciences GmbH|
|Principal Investigator:||Jorg Sahlmann, MD||Scope Life Sciences GmbH|