Safety and Pharmacokinetics of SNX-001 in Healthy Aged Volunteers
NCT01269476 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2011-01-04
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.
Conditions
- Safety
Interventions
- DRUG
-
SNX-001
3.6, 7.2, or 10.8 mg single dose or t.i.w.
- DRUG
-
Same volumes and frequency as active.
Sponsors & Collaborators
-
SeneXta Therapeutics SA
lead INDUSTRY
Principal Investigators
-
Jorg Sahlmann, MD · Scope Life Sciences GmbH
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-12-31
- Primary Completion
- 2010-06-30
- Completion
- 2010-08-31
Countries
- Germany
Study Locations
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