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

QurAlis

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: QRL-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT06877624

QRL-101-06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 6 patient groups

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

Experimental group

Description:

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:

Drug: QRL-101

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

Experimental group

Description:

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:

Drug: QRL-101

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

Experimental group

Description:

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:

Drug: QRL-101

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

Experimental group

Description:

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:

Drug: QRL-101

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

Experimental group

Description:

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:

Drug: QRL-101

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

Experimental group

Description:

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.

Treatment:

Drug: QRL-101