NCT06840925

A Clinical Trial to Evaluate the Relative Bioavailability of PRAX-628

A Phase 1, Randomized, Open-Label, 2-Way Crossover Clinical Trial in Healthy Participants to Evaluate the Relative Bioavailability of PRAX-628 Tablet Formulation Compared to Capsule Formulation

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Praxis Precision Medicines · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A phase I clinical trial to evaluate the relative bioavailability of PRAX-628 tablet formulation compared to capsule formulation

Detailed description

This Phase 1, randomized, open-label, 2-way crossover clinical trial is designed to investigate the relative bioavailability, pharmacokinetics (PK), safety, and tolerability of PRAX628 tablet formulation and PRAX-628 capsule formulation in healthy male or female participants.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	PRAX-628	Once daily oral

Timeline

• Start date: 2025-03-24
• Primary completion: 2025-05-30
• Completion: 2025-06-30
• First posted: 2025-02-21
• Last updated: 2025-02-21

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study