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

Phase 1

Active, not recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: QRL-101

• Registration Number: NCT06877624
• Lead Sponsor: QurAlis Corporation

Brief 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.

Study Timeline

• Study Start: 2025-01-10
• Study First Submitted: 2025-03-05
• Study First Submitted QC: 2025-03-11
• Study First Posted: 2025-03-14
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-04
• Primary Completion: 2025-05-25
• Study Completion: 2025-05-25

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Age 18 to 70 years of age inclusive at the time of signing the informed consent.
2. Clinical chemistry laboratory values within acceptable range for the population, as per investigator judgment.
3. Body mass index of 18 to 32 kg/m2 (inclusive).
4. Willing and able to practice effective contraception.

Exclusion Criteria

1. Currently enrolled in any other clinical trial involving a study drug or off-label use of a drug or device, or any other type of medical research judged not to be scientifically or medically compatible with this study.
2. Any participant in >4 studies a year and/or has participated in a clinical trial within 1 month of the expected dosing date.
3. History or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric, or neurological disease, convulsions, or any clinically significant laboratory abnormality that, in the judgment of the investigator, indicate a medical problem that would preclude study participation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Sequence 1 (Formulation 1, 2, and 3)	QRL-101	Participants randomized to Treatment Sequence 1 will receive Formulation 1 in the fasted condition in Treatment Period 1, followed by Formulation 1, 2, and 3 in the presence of a high-fat meal in Treatment Periods 2 through 4, respectively.
Treatment Sequence 2 (Formulation 2, 3, and 1)	QRL-101	Participants randomized to Treatment Sequence 2 will receive Formulation 2 in the fasted condition in Treatment Period 1, followed by Formulation 2, 3, and 1 in the presence of a high-fat meal in Treatment Periods 2 through 4, respectively.
Treatment Sequence 3 (Formulation 3, 1, and 2)	QRL-101	Participants randomized to Treatment Sequence 3 will receive Formulation 3 in the fasted condition in Treatment Period 1, followed by Formulation 3, 1, and 2 in the presence of a high-fat meal in Treatment Periods 2 through 4, respectively.
Treatment Sequence 4 (Formulation 2, 1, and 3)	QRL-101	Participants randomized to Treatment Sequence 4 will receive Formulation 1 in the fasted condition in Treatment Period 1, followed by Formulation 1, 3, and 2 in the presence of a high-fat meal in Treatment Periods 2 through 4, respectively.
Treatment Sequence 5 (Formulation 2, 1, and 3)	QRL-101	Participants randomized to Treatment Sequence 5 will receive Formulation 2 in the fasted condition in Treatment Period 1, followed by Formulation 2, 1, and 3 in the presence of a high-fat meal in Treatment Periods 2 through 4, respectively.
Treatment Sequence 6 (Formulation 3, 2, and 1)	QRL-101	Participants randomized to Treatment Sequence 6 will receive Formulation 3 in the fasted condition in Treatment Period 1, followed by Formulation 3, 2, and 1 in the presence of a high-fat meal in Treatment Periods 2 through 4, respectively.

Primary Outcome Measures

Name	Time	Method
Plasma PK profile (AUCinf)	Baseline through Follow up (Day 9)	The area under the curve to infinity
Plasma PK profile (AUClast)	Baseline through Follow up (Day 9)	The area under the curve to the last measurable time point
Plasma PK profile (Cmax)	Baseline through Follow up (Day 9)	Maximum concentration observed
Plasma PK profile (Ctrough)	Baseline through Follow up (Day 9)	Trough level concentration for defined dose regimen
Plasma PK profile (Tmax)	Baseline through Follow up (Day 9)	The time to peak drug concentration

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability	Baseline through Follow up (Day 9)	Adverse events (AEs) and serious adverse events (SAEs)

Trial Locations

Locations (1)

ICON plc. Van Swietenlaan 6; 🇳🇱 Groningen, Netherlands