ACTRN12620001292965
Completed
Phase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses and Food Effect of PRAX-562 in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Praxis Precision Medicines
- Enrollment
- 112
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Female or male and between the ages of 18 and 55 years, inclusive.
- •\- Weight of at least 50 kg with body mass index (BMI) between 18 and 30 kg/m2 (inclusive).
- •\- Medically healthy (without significant medical issues, e.g. high blood pressure)
Exclusion Criteria
- •\- Ongoing or history of any psychiatric, medical or surgical condition that might jeopardize the participant’s safety or interfere with the absorption, distribution, metabolism or excretion of the study drug.
- •\- Any abnormal ECG findings, laboratory value or physical examination findings
- •\- Positive ethanol, drug screen or cotinine test
- •\- Use of systemic prescription medications or over\-the\-counter (OTC) medication, including multivitamins, and dietary and herbal supplement within 2 weeks
- •\- Use of any experimental or investigational drug or device within 30 days
- •\- Donation or loss of 400 mL or more of blood within 8 weeks and/or donation of plasma within 7 days
Outcomes
Primary Outcomes
Not specified
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