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Safety and Pharmacokinetics of SNX-001 in Healthy Aged Volunteers

Sponsor
SeneXta Therapeutics SA (Industry)
Overall Status
Completed
CT.gov ID
NCT01269476
Collaborator
(none)
27
Enrollment
1
Location
2
Arms
8
Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
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 Design

Study Type:
Interventional
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 :
Dec 1, 2009
Actual Primary Completion Date :
Jun 1, 2010
Actual Study Completion Date :
Aug 1, 2010

Arms and Interventions

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 Names:
  • Oil vehicle

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Scope Life Sciences GmbH Hamburg Germany

    Sponsors and Collaborators

    • SeneXta Therapeutics SA

    Investigators

    • Principal Investigator: Jorg Sahlmann, MD, Scope Life Sciences GmbH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01269476
    Other Study ID Numbers:
    • SNX-001-PH1-09
    • 2009-011335-13
    First Posted:
    Jan 4, 2011
    Last Update Posted:
    Jan 4, 2011
    Last Verified:
    Dec 1, 2010
    Additional relevant MeSH terms:
    Fluorides
    Methanesulfonyl fluoride

    Study Results

    No Results Posted as of Jan 4, 2011