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

NCT06877624 | Completed Phase 1 DMC

• 1 other identifier: QRL-101-06
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (5)

• Plasma PK profile (AUCinf)

  The area under the curve to infinity

  Baseline through Follow up (Day 9)

• Plasma PK profile (AUClast)

  The area under the curve to the last measurable time point

  Baseline through Follow up (Day 9)

• Plasma PK profile (Cmax)

  Maximum concentration observed

  Baseline through Follow up (Day 9)

• Plasma PK profile (Ctrough)

  Trough level concentration for defined dose regimen

  Baseline through Follow up (Day 9)

• Plasma PK profile (Tmax)

  The time to peak drug concentration

  Baseline through Follow up (Day 9)

Secondary Outcomes (1)

• Safety and tolerability

  Baseline through Follow up (Day 9)

Study Arms (6)

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

EXPERIMENTAL

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.

Drug: QRL-101

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

EXPERIMENTAL

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.

Drug: QRL-101

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

EXPERIMENTAL

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.

Drug: QRL-101

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

EXPERIMENTAL

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.

Drug: QRL-101

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

EXPERIMENTAL

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.

Drug: QRL-101

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

EXPERIMENTAL

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.

Drug: QRL-101

Interventions

QRL-101 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 1 (Formulation 1, 2, and 3); Treatment Sequence 2 (Formulation 2, 3, and 1); Treatment Sequence 3 (Formulation 3, 1, and 2); Treatment Sequence 4 (Formulation 2, 1, and 3); Treatment Sequence 5 (Formulation 2, 1, and 3); Treatment Sequence 6 (Formulation 3, 2, and 1)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Any participant in \>4 studies a year and/or has participated in a clinical trial within 1 month of the expected dosing date.
• 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.

Sponsors & Collaborators

• QurAlis Corporation: lead

Study Sites (1)

ICON plc. Van Swietenlaan 6

Groningen, 9728 NZ, Netherlands

Location

Study Officials

• Salah Hadi, MD

  ICON plc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: A participant and investigator-blinded, randomized, open-label, single-dose, cross-over design will be used to minimize bias in this study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study will be a randomized, open-label, single-dose, cross-over study to evaluate the pharmacokinetics of 3 QRL-101 formulations in a fasted condition or in the presence of a high-fat meal in healthy participants.

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 14, 2025
• Study Start: January 10, 2025
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)