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NCT Number: NCT06681441

A 3-way Cross-over Study on the Effects of QRL-101 on Transcranial Magnetic Stimulation and Nerve Excitability in Healthy Participants

This is a phase I, prospective, single-center, randomized, double-blind, placebo-controlled, three-way cross-over study to evaluate the safety and tolerability of QRL-101 and investigate the pharmacodynamic effects of two dose levels of QRL-101 on transcranial magnetic stimulation (TMS) and nerve excitability threshold tracking (NETT) in healthy participants.

After screening and training, participants will be randomized to one of six treatment sequences of William's square balanced for first-order carry-over design consisting of two doses of QRL-101 or placebo, with at least seven days between each treatment.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre for Human Drug Research

Leiden, 2333, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Males and postmenopausal women between the ages ≥ 18 and ≤ 55.
  • BMI ≥ 18.0 and ≤ 32.0 kg/m2, and body weight ≥ 50 kg, at screening.
  • Willing and able to practice effective contraception from the screening through at least 2 days after their last dose of study treatment.
  • Participants must be able to communicate effectively (in Dutch) with the study personnel and be willing to comply with the requirements of the study.

Exclusion criteria

  • Evidence of any acute or chronic disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study.
  • History or presence of conditions which, in the judgment of the investigator, are known to interfere with drug absorption, distribution, metabolism, or excretion.
  • History or presence of conditions which might increase the risk of performing TMS (e.g., epilepsy, febrile seizures, intracranial mass lesion, hydrocephalus, clinically significant head injury or trauma, metal objects in the brain or skull, cochlear implant or a deep brain stimulation device)
  • Any condition that could interfere with the quality of, or ability to perform, TMS (e.g., an abnormal sleeping pattern, unremovable dreadlocks or hairpieces, or a resting motor threshold (rMT) of more than 75%.

*Other inclusion and exclusion criteria may apply*

Treatment and study plan

QRL-101 Dose A

Drug

All participants will receive three single-dose oral administrations in randomized order, scheduled across three separate study visits, with a 7-day washout period between each visit.

QRL-101 Dose B

Drug

All participants will receive three single-dose oral administrations in randomized order, scheduled across three separate study visits, with a 7-day washout period between each visit.

Placebo

Drug

All participants will receive three single-dose oral administrations in randomized order, scheduled across three separate study visits, with a 7-day washout period between each visit.

Primary outcomes

  1. Single pulse TMS-EMG motor evoked potential (MEP) amplitude (μV) compared to placebo

    Time frame: 3 study periods, with a washout period of at least 7 days between each visit. Each study period consists of 2 nights and 1 study day.

    To compare two dose levels of QRL-101 versus placebo on cortical excitability

  2. mNETT strength-duration time constant (SDTC) compared to placebo SDTC

    Time frame: 3 study periods, with a washout period of at least 7 days between each visit. Each study period consists of 2 nights and 1 study day.

    To compare two dose levels of QRL-101 versus placebo on peripheral motor nerve excitability

Secondary outcomes

  1. Other Single pulse TMS-EMG MEP parameters

    Time frame: 3 study periods, with a washout period of at least 7 days between each visit. Each study period consists of 2 nights and 1 study day.

    To compare two dose levels of QRL-101 versus placebo on cortical excitability

  2. pEEG: power in the alpha frequency bands in resting state with eyes open and closed

    Time frame: 3 study periods, with a washout period of at least 7 days between each visit. Each study period consists of 2 nights and 1 study day.

    To compare two dose levels of QRL-101 versus placebo on spontaneous brain activity measured by resting state pharmaco-encephalography (pEEG)

  3. Incidence of AEs and SAEs

    Time frame: 3 study periods, with a washout period of at least 7 days between each visit. Each study period consists of 2 nights and 1 study day.

    Absolute values and changes from baseline values in vital signs, clinical laboratory tests, and ECG parameters

  4. Plasma QRL-101 concentrations

    Time frame: 3 study periods, with a washout period of at least 7 days between each visit. Each study period consists of 2 nights and 1 study day.

    AUC0-24

Sponsors and collaborators

Lead sponsor

QurAlis Corporation

Industry

Collaborators

  • Centre for Human Drug Research, Netherlands

Registry information

Official study title

A Phase I, Randomized, Double-blind, Placebo-controlled, 3-way Cross-over Study to Assess the Pharmacodynamic Effects of Two-dose Levels of QRL-101 on Transcranial Magnetic Stimulation and Nerve Excitability Threshold Tracking in Healthy Participants

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 8, 2024
Registry last updated
Mar 25, 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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