Safety and Pharmacokinetics of SNX-001 in Healthy Aged Volunteers

Safety Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01269476
• Other study ID #: SNX-001-PH1-09
• Secondary ID: 2009-011335-13
• Status: Completed
• Phase: Phase 1
• First received: September 22, 2010
• Last updated: December 31, 2010
• Start date: December 2009
• Est. completion date: August 2010

Study information

• Verified date: December 2010
• Source: SeneXta Therapeutics SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Safety

Intervention

Drug:
• SNX-001
3.6, 7.2, or 10.8 mg single dose or t.i.w.
• Placebo
Same volumes and frequency as active.

Locations

Country	Name	City	State
Germany	Scope Life Sciences GmbH	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
SeneXta Therapeutics SA

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	Effect of dose on pharmacokinetic (PK) parameters	Pharmacokinetic parameters after single and multiple dose administration of SNX-001 (3.6, 7.2 and 10.8 mg)	After single (Day 1) and multiple (Day 12) doses	No