Evaluating the Safety and Relative Bioavailability of Three SPN-817 Treatments (A, B and C) in Healthy Adult Subjects
Early Phase 1
Completed
- Conditions
- Healthy Volunteer
- Interventions
- Drug: SPN-817, Treatment BDrug: SPN-817, Treatment CDrug: BIS-001, Treatment A
- Registration Number
- NCT05102552
- Lead Sponsor
- Supernus Pharmaceuticals, Inc.
- Brief Summary
Randomized, Open-Label, Multiple Dose study to evaluate the relative bioavailability of Treatment A, Treatment B, and Treatment C
- Detailed Description
A Single-Center, Randomized, Open-label, Multiple-Dose, Single-Sequence Crossover Study, Evaluating the Safety and Relative Bioavailability of Three SPN-817 Treatments (A, B and C) in Healthy Adult Subjects
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cohort 1 SPN-817, Treatment B BIS-001: Treatment A and SPN-817: Treatment B Cohort 2 BIS-001, Treatment A BIS-001: Treatment A and SPN-817: Treatment C Cohort 1 BIS-001, Treatment A BIS-001: Treatment A and SPN-817: Treatment B Cohort 2 SPN-817, Treatment C BIS-001: Treatment A and SPN-817: Treatment C
- Primary Outcome Measures
Name Time Method Relative Bioavailability 22 days Peak (Cmax) plasma concentration
- Secondary Outcome Measures
Name Time Method To assess the safety and tolerability of multiple oral administration of SPN-817 in healthy adult subjects. 25 days Adverse Events (occurrence/incidence, seriousness, severity, and causality assessment)
Trial Locations
- Locations (1)
Nucleus Network
🇦🇺Melbourne, Victoria, Australia