Safety and Pharmacokinetics of SNX-001 in Healthy Aged Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01269476
Recruitment Status : Completed
First Posted : January 4, 2011
Last Update Posted : January 4, 2011
Information provided by:
SeneXta Therapeutics SA

Brief Summary:

This is a randomised, double-blind, group-sequential, placebo-controlled, safety and pharmacokinetic study in healthy, aged volunteers.


  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.

Condition or disease Intervention/treatment Phase
Safety Drug: SNX-001 Drug: Placebo Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : August 2010

Arm Intervention/treatment
Experimental: SNX-001 Drug: SNX-001
3.6, 7.2, or 10.8 mg single dose or t.i.w.
Other Names:
  • methanesulfonyl fluoride
  • MSF

Placebo Comparator: Placebo Drug: Placebo
Same volumes and frequency as active.
Other Name: Oil vehicle

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01269476

Scope Life Sciences GmbH
Hamburg, Germany
Sponsors and Collaborators
SeneXta Therapeutics SA
Principal Investigator: Jorg Sahlmann, MD Scope Life Sciences GmbH

Responsible Party: Dr. Enrico Braglia, SeneXta Therapeutics SA Identifier: NCT01269476     History of Changes
Other Study ID Numbers: SNX-001-PH1-09
2009-011335-13 ( EudraCT Number )
First Posted: January 4, 2011    Key Record Dates
Last Update Posted: January 4, 2011
Last Verified: December 2010

Additional relevant MeSH terms:
Methanesulfonyl fluoride
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs