A Phase 1 interventional study of KRP-S124 Low Dose and Placebo in Healthy Participants, sponsored by Kyorin Pharmaceutical Co.,Ltd. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Kyorin Pharmaceutical Co.,Ltd · Phase 1, Interventional, and Treatment
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.
Kyorin Pharmaceutical Co.,Ltd is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a single oral dose of Therapeutic dose (T) (KRP-S124 \[low dose\]) and placebo matched to KRP-S124.
Drug: KRP-S124 Low Dose · Other: Placebo
Participants will receive a single oral dose of Supratherapeutic dose 1 (ST1) (KRP-S124 \[medium dose\]) and placebo matched to KRP-S124.
Other: Placebo · Drug: KRP-S124 Medium Dose
Participants will receive a single oral dose of Supratherapeutic dose 2 (ST2) (KRP-S124 \[high dose\]).
Drug: KRP-S124 High Dose
Participants will receive a single oral dose of placebo matched to KRP-S124.
Other: Placebo
Participants will receive a single oral dose of moxifloxacin (M).
Drug: Moxifloxacin
Orally.
Orally.
Orally.
Orally.
Orally.
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.
Time frame: Baseline (pre-dose at -1.5, -1, -0.5 hours) up to 24 hours post-dose
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.
Time frame: Baseline (pre-dose at -1.5, -1, -0.5 hours) up to 24 hours post-dose
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.
Time frame: Baseline (pre-dose at -1.5, -1, -0.5 hours) up to 24 hours post-dose
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.
Time frame: Baseline (pre-dose at -1.5, -1, -0.5 hours) up to 24 hours post-dose
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.
Time frame: Baseline (pre-dose at -1.5, -1, -0.5 hours) up to 24 hours post-dose
Number of Participants With Treatment-emergent Changes in ECG Morphology for KRP-S124
Time frame: Baseline (pre-dose at -1.5, -1, -0.5 hours) up to 24 hours post-dose
Area Under the Plasma Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC0-t) for KRP-S124 and Moxifloxacin
Time frame: Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) for KRP-S124 and Moxifloxacin
Time frame: Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2
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.
Time frame: Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2
Maximum Observed Plasma Concentration (Cmax) for KRP-S124 and Moxifloxacin
Time frame: Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2
Time to Reach Maximum Observed Plasma Concentration (Tmax) for KRP-S124 and Moxifloxacin
Time frame: Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2
Terminal Elimination Half-life (T1/2 el) for KRP-S124 and Moxifloxacin
Time frame: Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2
Terminal Elimination Rate Constant (Kel) for KRP-S124 and Moxifloxacin
Time frame: Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2
Apparent Clearance (Cl/F) for KRP-S124 and Moxifloxacin
Time frame: Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2
Apparent Volume of Distribution (Vz/F) for KRP-S124 and Moxifloxacin
Time frame: Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2
Number of Participants With Adverse Events
Time frame: Up to approximately 10 weeks
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Values
Time frame: Up to approximately 10 weeks
Number of Participants With Clinically Significant Changes From Baseline in Vital Signs Measurements
Time frame: Up to approximately 10 weeks
Number of Participants With Clinically Significant Changes From Baseline in 12-lead Safety ECG Measurements
Time frame: Up to approximately 10 weeks
Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Findings
Time frame: Up to approximately 10 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Feb 2027, 3 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Kyorin Pharmaceutical Co.,Ltd