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Completed

NCT Number: NCT06877624

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

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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON plc. Van Swietenlaan 6

Groningen, 9728 NZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Plasma PK profile (AUCinf)

    Time frame: Baseline through Follow up (Day 9)

    The area under the curve to infinity

  2. Plasma PK profile (AUClast)

    Time frame: Baseline through Follow up (Day 9)

    The area under the curve to the last measurable time point

  3. Plasma PK profile (Cmax)

    Time frame: Baseline through Follow up (Day 9)

    Maximum concentration observed

  4. Plasma PK profile (Ctrough)

    Time frame: Baseline through Follow up (Day 9)

    Trough level concentration for defined dose regimen

  5. Plasma PK profile (Tmax)

    Time frame: Baseline through Follow up (Day 9)

    The time to peak drug concentration

Secondary outcomes

  1. Safety and tolerability

    Time frame: Baseline through Follow up (Day 9)

    Adverse events (AEs) and serious adverse events (SAEs)

Sponsors and collaborators

Lead sponsor

QurAlis Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 14, 2025
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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