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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01269476

Enrollment

Registered

2011-01-04

Start date

2009-12-31

Completion date

2010-08-31

Last updated

2011-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Safety

Brief 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.

Interventions

DRUGSNX-001

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

DRUGPlacebo

Same volumes and frequency as active.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Relationship of clinical safety measurements to dose	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

Secondary

Measure	Time frame	Description
Effect of dose on pharmacokinetic (PK) parameters	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)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026