NCT01269476

Brief Summary

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

  1. 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. 2.to establish SNX-001 pharmacokinetic profile.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 4, 2011

Completed
Last Updated

January 4, 2011

Status Verified

December 1, 2010

Enrollment Period

6 months

First QC Date

September 22, 2010

Last Update Submit

December 31, 2010

Conditions

Safety

Outcome Measures

Primary Outcomes (1)

  • Relationship of clinical safety measurements to dose

    Adverse events (AEs), vital signs, electrocardiogram (ECG), Acetylcholinesterase (AChE) inhibition, laboratory parameters after single and multiple dose administration

    Throughout 14-day study period (Days 1, 2, 3, 10, 12, 13, 14) and 7 days after last dose (Day 21)

Secondary Outcomes (1)

  • Effect of dose on pharmacokinetic (PK) parameters

    After single (Day 1) and multiple (Day 12) doses

Study Arms (2)

SNX-001

EXPERIMENTAL
Drug: SNX-001

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

SNX-001DRUG

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

Also known as: methanesulfonyl fluoride, MSF
SNX-001
PlaceboDRUG

Same volumes and frequency as active.

Also known as: Oil vehicle
Placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy males or females
  • Physically and mentally healthy subjects
  • Body weight \>60 kg and body weight ≤ 100 kg

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scope Life Sciences GmbH

Hamburg, Germany

Location

MeSH Terms

Interventions

methanesulfonyl fluorideOils

Intervention Hierarchy (Ancestors)

Lipids

Study Officials

  • Jorg Sahlmann, MD

    Scope Life Sciences GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 22, 2010

First Posted

January 4, 2011

Study Start

December 1, 2009

Primary Completion

June 1, 2010

Study Completion

August 1, 2010

Last Updated

January 4, 2011

Record last verified: 2010-12

Locations

DE(1)