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
  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:


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
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, see Learn About Clinical Studies.

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 September 18, 2014