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Completed

NCT Number: NCT01269476

Safety and Pharmacokinetics of SNX-001 in Healthy Aged Volunteers

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.

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Key information

Conditions

Safety

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Scope Life Sciences GmbH

Hamburg, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SNX-001

Drug

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

Other names: methanesulfonyl fluoride, MSF

Placebo

Drug

Same volumes and frequency as active.

Other names: Oil vehicle

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

SeneXta Therapeutics SA

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 4, 2011
Registry last updated
Jan 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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