NCT06877624

A Study Evaluating the Pharmacokinetics of Three QRL-101 Formulations in Healthy Participants

A Randomized, Open-Label, Single Dose, Cross-Over Study to Evaluate the Pharmacokinetics of Three QRL-101 Formulations in a Fasted Condition or in the Presence of a High Fat Meal in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: QurAlis Corporation · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the pharmacokinetics of three QRL-101 formulations in a fasted condition or in the presence of a high-fat meal in healthy participants.

Detailed description

This is a randomized, open-label, single-dose, crossover study to evaluate the PK of three formulations of QRL-101 beginning in a fasted condition before moving to a fed cross-over design. Approximately 24 healthy participants will be enrolled in a 3-formulation, 4-period, 6-sequence crossover study design to evaluate the PK characteristics of three formulations of QRL-101.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	QRL-101	This cross-over design study will evaluate three formulations (Formulations 1, 2, and 3) of QRL-101, beginning in a fasted condition before moving to a fed cross-over design.

Timeline

• Start date: 2025-01-10
• Primary completion: 2025-05-15
• Completion: 2025-05-15
• First posted: 2025-03-14
• Last updated: 2025-08-26

Locations

1 site across 1 country: Netherlands