Phase 1 Placebo Controlled Study of the Safety, Activity and Pharmacokinetics of HQK-1001 in Healthy Subjects
NCT00717262 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41
Last updated 2009-01-16
Summary
The purpose of this study is to evaluate the safety, activity and pharmacokinetics of a new investigational drug (HQK-1001) in healthy human volunteers. This study will also evaluate if there are differences in these parameters when HQK-1001 is administered in a fed versus a fasted state.
Conditions
- Healthy
Interventions
- DRUG
-
HQK-1001
HQK-1001 (5, 10 or 15 mg/kg) capsules administered once a day, orally, for 14 days.
- DRUG
-
Matching placebo capsules administered once a day, orally, for 14 days.
Sponsors & Collaborators
-
HemaQuest Pharmaceuticals Inc.
lead INDUSTRY
Principal Investigators
-
Robin Downey, MD · Charles River Clinical Services Northwest
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2008-05-31
- Primary Completion
- 2008-08-31
- Completion
- 2008-09-30
Countries
- United States
Study Locations
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