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

NCT ID: NCT06877624

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-10
• Study Completion Date: 2025-05-15

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment Sequence 1 (Formulation 1, 2, and 3)

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.

Group Type: EXPERIMENTAL

QRL-101

Intervention Type: DRUG

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.

Treatment Sequence 2 (Formulation 2, 3, and 1)

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.

Group Type: EXPERIMENTAL

QRL-101

Intervention Type: DRUG

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.

Treatment Sequence 3 (Formulation 3, 1, and 2)

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.

Group Type: EXPERIMENTAL

QRL-101

Intervention Type: DRUG

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.

Treatment Sequence 4 (Formulation 2, 1, and 3)

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.

Group Type: EXPERIMENTAL

QRL-101

Intervention Type: DRUG

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.

Treatment Sequence 5 (Formulation 2, 1, and 3)

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.

Group Type: EXPERIMENTAL

QRL-101

Intervention Type: DRUG

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.

Treatment Sequence 6 (Formulation 3, 2, and 1)

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.

Group Type: EXPERIMENTAL

QRL-101

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

QurAlis Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Salah Hadi, MD

Role: PRINCIPAL_INVESTIGATOR

ICON plc

Locations

ICON plc. Van Swietenlaan 6

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

QRL-101-06

Identifier Type: -

Identifier Source: org_study_id