Study to Evaluate the Safety and Pharmacokinetics of SPI-1005
NCT01452607 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2016-06-29
Summary
A study to determine the safety, tolerability, and pharmacokinetics of SPI-1005 capsules in healthy adults.
Conditions
Interventions
- DRUG
-
SPI-1005
200 mg Ebselen oral capsules (SPI-1005), single dose
- DRUG
-
0 mg Ebselen oral capsules (SPI-1000), single dose
Sponsors & Collaborators
-
Sound Pharmaceuticals, Incorporated
lead INDUSTRY
Principal Investigators
-
James C. Kisicki, M.D. · MDS Pharma Services
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2006-05-31
- Primary Completion
- 2006-08-31
- Completion
- 2006-08-31
Countries
- United States
Study Locations
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