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
NCT07919314, Phase 1, Recruiting, Kyorin Pharmaceutical Co.,Ltd
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | 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 | ClinicalTrials.gov |
| NCT number | NCT07919314 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 1 | ClinicalTrials.gov |
| Enrollment | 40 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Kyorin Pharmaceutical Co.,Ltd | ClinicalTrials.gov |
| Conditions | Healthy Participants | ClinicalTrials.gov |
| Interventions | KRP-S124 Low Dose, Placebo, Moxifloxacin, KRP-S124 Medium Dose, KRP-S124 High Dose | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Placebo-corrected Change From Baseline in Fridericia's Corrected QT interval (delta delta [ΔΔ]QTcF) for KRP-S124 | Baseline (pre-dose at -1.5, -1, -0.5 hours) up to 24 hours post-dose | Placebo-corrected change from baseline QTcF will be reported using a linear mixed-effects model analysis. | ClinicalTrials.gov |
| Secondary | Placebo-corrected Change From Baseline in Heart Rate (ΔΔHR) for KRP-S124 | Baseline (pre-dose at -1.5, -1, -0.5 hours) up to 24 hours post-dose | Placebo-corrected change from baseline HR will be reported using a linear mixed-effects model analysis. | ClinicalTrials.gov |
| Secondary | Placebo-corrected Change From Baseline in PR interval (ΔΔPR) for KRP-S124 | Baseline (pre-dose at -1.5, -1, -0.5 hours) up to 24 hours post-dose | Placebo-corrected change from baseline PR interval will be reported using a linear mixed-effects model analysis. | ClinicalTrials.gov |
| Secondary | Placebo-corrected Change From Baseline in QRS interval (ΔΔQRS) for KRP-S124 | Baseline (pre-dose at -1.5, -1, -0.5 hours) up to 24 hours post-dose | Placebo-corrected change from baseline in QRS interval will be reported using a linear mixed-effects model analysis. | ClinicalTrials.gov |
| Secondary | Number of Participants With Categorical Outliers for QTcF, HR, PR and QRS | Baseline (pre-dose at -1.5, -1, -0.5 hours) up to 24 hours post-dose | 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. | ClinicalTrials.gov |
| Secondary | Number of Participants With Treatment-emergent Changes in ECG Morphology for KRP-S124 | Baseline (pre-dose at -1.5, -1, -0.5 hours) up to 24 hours post-dose | ClinicalTrials.gov | |
| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC0-t) for KRP-S124 and Moxifloxacin | Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2 | ClinicalTrials.gov | |
| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) for KRP-S124 and Moxifloxacin | Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2 | ClinicalTrials.gov | |
| Secondary | Percentage of AUC0-inf Due to Extrapolation From the Time of the Last Observed Concentration to Infinity (Residual Area) for KRP-S124 and Moxifloxacin | Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2 | Residual area will be calculated as \[1 - (AUC0-t divided by AUC0-inf)\] multiplied by 100. | ClinicalTrials.gov |
| Secondary | Maximum Observed Plasma Concentration (Cmax) for KRP-S124 and Moxifloxacin | Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2 | ClinicalTrials.gov | |
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) for KRP-S124 and Moxifloxacin | Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2 | ClinicalTrials.gov | |
| Secondary | Terminal Elimination Half-life (T1/2 el) for KRP-S124 and Moxifloxacin | Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2 | ClinicalTrials.gov | |
| Secondary | Terminal Elimination Rate Constant (Kel) for KRP-S124 and Moxifloxacin | Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2 | ClinicalTrials.gov | |
| Secondary | Apparent Clearance (Cl/F) for KRP-S124 and Moxifloxacin | Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2 | ClinicalTrials.gov | |
| Secondary | Apparent Volume of Distribution (Vz/F) for KRP-S124 and Moxifloxacin | Pre-dose up to 12 hours post-dose on Day 1 and 24 hours post-dose on Day 2 | ClinicalTrials.gov | |
| Secondary | Number of Participants With Adverse Events | Up to approximately 10 weeks | ClinicalTrials.gov | |
| Secondary | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Values | Up to approximately 10 weeks | ClinicalTrials.gov | |
| Secondary | Number of Participants With Clinically Significant Changes From Baseline in Vital Signs Measurements | Up to approximately 10 weeks | ClinicalTrials.gov | |
| Secondary | Number of Participants With Clinically Significant Changes From Baseline in 12-lead Safety ECG Measurements | Up to approximately 10 weeks | ClinicalTrials.gov | |
| Secondary | Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Findings | Up to approximately 10 weeks | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)