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Healthy ParticipantsPhase 1NCT07919314

A Study to Evaluate the Effects of Therapeutic and Supratherapeutic Doses of KRP-S124 Compared to Placebo With Moxifloxacin on QTc Interval in Healthy Participants

A Phase 1 study testing KRP-S124 Low Dose, Moxifloxacin and KRP-S124 Medium Dose in people with Healthy Participants, run by Kyorin Pharmaceutical Co.,Ltd at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is being done to see how KRP-S124 affects the electrical activity of the heart (known as the QTc interval [QT interval corrected for heart rate]) in healthy volunteers. This helps researchers check the heart safety of the study drug. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
KRP-S124 Low Dose, Moxifloxacin and KRP-S124 Medium Dose
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteCanada
Study dates
14 Oct 2026to 12 Feb 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male or non-childbearing potential female, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), greater than or equal to (>=) 18 and less than or equal to (<=) 55 years of age, with body mass index (BMI) greater than (>) 18.5 and less than (<) 30.0 kilograms per square meter (kg/m^2) and body weight >=50.0 kilograms (kg) for males and >=45.0 kg for females.
  • Female participants of non-childbearing potential should not donate ova for 90 days after the last dose.
  • Male participants (including men who have had a vasectomy) with a pregnant partner must agree to use a condom from the first dose and for 90 days after the last dose.
  • Male participants must be willing not to donate sperm for 90 days after the last dose.
  • Able to understand the study procedures and provide signed informed consent to participate in the study.

Who cannot join

  • Any clinically significant abnormal finding at physical examination at screening or Baseline (Day -1 of Period 1).
  • Clinically significant abnormal laboratory test results or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody at screening.
  • Any of the following laboratory parameters above the upper limit of normal (ULN) values at Screening or Baseline (Day -1 of Period 1): alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl-transpeptidase (GGT), direct bilirubin and total bilirubin. Only abnormal values between 1-1.5 * ULN may be repeated once for confirmation to below ULN.
  • Known allergic reactions to KRP-S124 or other related drugs, or to any excipient in the formulation.
  • Clinically significant vital signs abnormalities (systolic blood pressure lower than 90 or over 140 millimeters of mercury [mmHg], diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 beats per minute [bpm]) at screening or Baseline (Day -1 of Period 1).
  • History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to screening.
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  • History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 10 units for women or 15 units for men of alcohol per week (1 unit = 340 mL of beer 5 percent (%), 140 mL of wine 12%, or 45 mL of distilled alcohol 40%).
  • Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing (or 5 half-lives, whichever is longer), administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing (or 5 half-lives, whichever is longer), or concomitant participation in an investigational study involving no drug or device administration.
  • History of sustained and non-sustained cardiac arrhythmias (ECG demonstrated), family history of sudden cardiac death, and history of additional risk factors for Torsade-de-pointes, (e.g. [for example]: heart failure, hypokalemia, unexplained syncope, family history of Long QT Syndrome).
  • Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Development Center Kyorin Pharmaceutical Co., Ltd. contact

+81-3-6368-4834

ml-kyorin_clinicaltrials.gov@mb.kyorin-pharm.co.jp

Canada1 site, 1 recruiting
  • Syneos Health

    Québec, Quebec

    Recruiting

Other trials in Canada

About this study

Official title: A Randomized, Partially Double-Blind, Five-Period, Five-Treatment, Crossover Study to Assess the Effects of KRP-S124 on QTc Interval Using Therapeutic and Supratherapeutic Doses Compared to Placebo, With Moxifloxacin as a Positive Control, in Healthy Participants: A Thorough QTc Study

This study is being done to see how KRP-S124 affects the electrical activity of the heart (known as the QTc interval [QT interval corrected for heart rate]) in healthy volunteers. This helps researchers check the heart safety of the study drug.

Being tested
KRP-S124 Low Dose, Placebo, Moxifloxacin, KRP-S124 Medium Dose, KRP-S124 High Dose
Keywords
Thorough QT Study, KRP-S124

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KRP-S124 Low DoseDrug

    Orally.

  • PlaceboOther

    Orally.

  • MoxifloxacinDrug

    Orally.

  • KRP-S124 Medium DoseDrug

    Orally.

  • KRP-S124 High DoseDrug

    Orally.

Study groups in NCT07919314
Study groupRoleWhat they receive
Treatment T (Therapeutic Dose)ExperimentalParticipants will receive a single oral dose of Therapeutic dose (T) (KRP-S124 [low dose]) and placebo matched to KRP-S124.
Receives: Drug: KRP-S124 Low Dose; Other: Placebo
Treatment ST1 (Supratherapeutic Dose 1)ExperimentalParticipants will receive a single oral dose of Supratherapeutic dose 1 (ST1) (KRP-S124 [medium dose]) and placebo matched to KRP-S124.
Receives: Other: Placebo; Drug: KRP-S124 Medium Dose
Treatment ST2 (Supratherapeutic Dose 2)ExperimentalParticipants will receive a single oral dose of Supratherapeutic dose 2 (ST2) (KRP-S124 [high dose]).
Receives: Drug: KRP-S124 High Dose
Treatment P (Placebo)Placebo comparatorParticipants will receive a single oral dose of placebo matched to KRP-S124.
Receives: Other: Placebo
Treatment M (Moxifloxacin)Active comparatorParticipants will receive a single oral dose of moxifloxacin (M).
Receives: Drug: Moxifloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Placebo-corrected Change From Baseline in Fridericia's Corrected QT interval (delta delta [ΔΔ]QTcF) for KRP-S124

    Placebo-corrected change from baseline QTcF will be reported using a linear mixed-effects model analysis.

    Measured: Baseline (pre-dose at -1.5, -1, -0.5 hours) up to 24 hours post-dose

Secondary outcomes (19)
  1. Placebo-corrected Change From Baseline in Heart Rate (ΔΔHR) for KRP-S124

    Placebo-corrected change from baseline HR will be reported using a linear mixed-effects model analysis.

    Measured: Baseline (pre-dose at -1.5, -1, -0.5 hours) up to 24 hours post-dose

  2. Placebo-corrected Change From Baseline in PR interval (ΔΔPR) for KRP-S124

    Placebo-corrected change from baseline PR interval will be reported using a linear mixed-effects model analysis.

    Measured: Baseline (pre-dose at -1.5, -1, -0.5 hours) up to 24 hours post-dose

  3. Placebo-corrected Change From Baseline in QRS interval (ΔΔQRS) for KRP-S124

    Placebo-corrected change from baseline in QRS interval will be reported using a linear mixed-effects model analysis.

    Measured: Baseline (pre-dose at -1.5, -1, -0.5 hours) up to 24 hours post-dose

  4. Number of Participants With Categorical Outliers for QTcF, HR, PR and QRS

    HR, PR, QRS, and QTc will be measured by continuous electrocardiogram (ECG) recordings. Number of participants with categorical outliers for QTcF, HR, PR and QRS will be reported.

    Measured: Baseline (pre-dose at -1.5, -1, -0.5 hours) up to 24 hours post-dose

  5. Number of Participants With Treatment-emergent Changes in ECG Morphology for KRP-S124

    Measured: Baseline (pre-dose at -1.5, -1, -0.5 hours) up to 24 hours post-dose

  6. Area Under the Plasma Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC0-t) for KRP-S124 and Moxifloxacin

    Measured: Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2

  7. Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) for KRP-S124 and Moxifloxacin

    Measured: Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2

  8. Percentage of AUC0-inf Due to Extrapolation From the Time of the Last Observed Concentration to Infinity (Residual Area) for KRP-S124 and Moxifloxacin

    Residual area will be calculated as [1 - (AUC0-t divided by AUC0-inf)] multiplied by 100.

    Measured: Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2

  9. Maximum Observed Plasma Concentration (Cmax) for KRP-S124 and Moxifloxacin

    Measured: Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2

  10. Time to Reach Maximum Observed Plasma Concentration (Tmax) for KRP-S124 and Moxifloxacin

    Measured: Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2

  11. Terminal Elimination Half-life (T1/2 el) for KRP-S124 and Moxifloxacin

    Measured: Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2

  12. Terminal Elimination Rate Constant (Kel) for KRP-S124 and Moxifloxacin

    Measured: Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2

  13. Apparent Clearance (Cl/F) for KRP-S124 and Moxifloxacin

    Measured: Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2

  14. Apparent Volume of Distribution (Vz/F) for KRP-S124 and Moxifloxacin

    Measured: Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2

  15. Number of Participants With Adverse Events

    Measured: Up to approximately 10 weeks

  16. Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Values

    Measured: Up to approximately 10 weeks

  17. Number of Participants With Clinically Significant Changes From Baseline in Vital Signs Measurements

    Measured: Up to approximately 10 weeks

  18. Number of Participants With Clinically Significant Changes From Baseline in 12-lead Safety ECG Measurements

    Measured: Up to approximately 10 weeks

  19. Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Findings

    Measured: Up to approximately 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2026
  2. Study start14 Oct 2026
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion12 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07919314
Sponsor's protocol ID
KRPS124-T101
Status last verified
Oct 2026
First submitted
31 Oct 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KRP-S124 Low Dose, Moxifloxacin and KRP-S124 Medium Dose in people with Healthy Participants, run by Kyorin Pharmaceutical Co.,Ltd at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Development Center Kyorin Pharmaceutical Co., Ltd. (+81-3-6368-4834, ml-kyorin_clinicaltrials.gov@mb.kyorin-pharm.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Placebo-corrected Change From Baseline in Fridericia's Corrected QT interval (delta delta [ΔΔ]QTcF) for KRP-S124 (time frame: Baseline (pre-dose at -1.5, -1, -0.5 hours) up to 24 hours post-dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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