Single-Dose Safety Study of APD791 in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Registration Number
- NCT00529646
- Lead Sponsor
- Arena Pharmaceuticals
- Brief Summary
The APD791-001 study is designed primarily to evaluate the safety and tolerability of APD791 when administered as a single oral dose to healthy adult subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
- Healthy adult men and women, ages 19-45
- Non smokers
Exclusion Criteria
- History of a bleeding disorder
- Recently donated blood or had significant blood loss
- Current use of a prescription medication
- Pregnant females
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety measures to include adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical lab parameters
- Secondary Outcome Measures
Name Time Method Pharmacokinetic and pharmacodynamic assessments
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of APD791 in modulating its target in phase 1 trials?
How does APD791 compare to other APD compounds in tolerability and pharmacokinetics profiles?
What adverse events are associated with APD791 in single-dose phase 1 studies?
Are there specific biomarkers identified for APD791 response in healthy volunteers?
What is the therapeutic potential of APD791 in relation to Arena Pharmaceuticals' other drug candidates?
Trial Locations
- Locations (1)
MDS Pharma Services
🇺🇸Lincoln, Nebraska, United States
MDS Pharma Services🇺🇸Lincoln, Nebraska, United States