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Safety and Pharmacokinetics of SNX-001 in Healthy Aged Volunteers

This study has been completed.
Sponsor:
Information provided by:
SeneXta Therapeutics SA
ClinicalTrials.gov Identifier:
NCT01269476
First received: September 22, 2010
Last updated: December 31, 2010
Last verified: December 2010
History of Changes
  Purpose

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.

Condition Intervention Phase
Safety
 Drug: SNX-001
Drug: Placebo
 Phase 1

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by SeneXta Therapeutics SA:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Enrollment: 27
Study Start Date: December 2009
Study Completion Date: August 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269476

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

No publications provided

Responsible Party: Dr. Enrico Braglia, SeneXta Therapeutics SA
ClinicalTrials.gov Identifier: NCT01269476     History of Changes
Other Study ID Numbers: SNX-001-PH1-09, 2009-011335-13
Study First Received: September 22, 2010
Last Updated: December 31, 2010
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on May 16, 2013