Recruiting
Phase 1

KRP-S124

Sponsor:

Kyorin Pharmaceutical Co.,Ltd

Code:

NCT07919314

Conditions

Healthy Participants

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

KRP-S124 Low Dose

Placebo

Moxifloxacin

KRP-S124 Medium Dose

KRP-S124 High Dose

Study Details

Brief 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.

Conditions

Healthy Participants

Study ID

NCT07919314

Start date

Oct 14, 2026

Status verified date

Oct, 2026

Completion date

Feb 12, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment T (Therapeutic Dose)

Participants will receive a single oral dose of Therapeutic dose (T) (KRP-S124 \[low dose\]) and placebo matched to KRP-S124.

experimental: Treatment ST1 (Supratherapeutic Dose 1)

Participants will receive a single oral dose of Supratherapeutic dose 1 (ST1) (KRP-S124 \[medium dose\]) and placebo matched to KRP-S124.

experimental: Treatment ST2 (Supratherapeutic Dose 2)

Participants will receive a single oral dose of Supratherapeutic dose 2 (ST2) (KRP-S124 \[high dose\]).

placebo comparator: Treatment P (Placebo)

Participants will receive a single oral dose of placebo matched to KRP-S124.

active comparator: Treatment M (Moxifloxacin)

Participants will receive a single oral dose of moxifloxacin (M).

Interventions

KRP-S124 Low Dose

Orally.

Placebo

Orally.

Moxifloxacin

Orally.

KRP-S124 Medium Dose

Orally.

KRP-S124 High Dose

Orally.

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 ]

Central Contacts and Locations

Central contacts

Clinical Development Center Kyorin Pharmaceutical Co., Ltd.

+81-3-6368-4834ml-kyorin_clinicaltrials.gov@mb.kyorin-pharm.co.jp

Locations

Syneos Health

Recruiting

Québec, Quebec, Canada

More Information

Sponsor

Kyorin Pharmaceutical Co.,Ltd

Last update posted

Nov 5, 2026

Last verified

Oct, 2026

Keywords

  • Thorough QT Study
  • KRP-S124

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-06. This information was provided to ClinicalTrials.gov by Kyorin Pharmaceutical Co.,Ltd on 2026-11-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.