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A Study to Evaluate the Effects of KP-001 on the QT/QTc Intervals in Healthy Adults

NCT06649942 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-09-17

No results posted yet for this study

Summary

This is a Phase 1, single-center, randomized, single-blind (participants are blinded), placebo controlled, four-way cross over TQT study (4×4 Williams square design) to investigate the effect of KP-001 on the QTc interval using open-label moxifloxacin as an active control, in adult healthy volunteers.

KP-001 and placebo (dry syrup) will be administered in blinded manner to participants, and the moxifloxacin (tablet) will be administered in open-label manner.Total duration of study participation for each participant is approximately 8 weeks.

Cardiodynamic ECG evaluations will be performed at separate locations and cardiodynamic ECG evaluators will be blinded to treatment group analyzed, ie, blinded to each of the study interventions including moxifloxacin.

Conditions

  • Healthy Volunteers - Male and Female

Interventions

DRUG

KP-001

KP-001 100 mg + placebo

DRUG

KP-001

KP-001 400 mg

DRUG

Moxifloxacin 400 mg

moxifloxacin 400 mg tablet

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Kaken Pharmaceutical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2025-03-24
Completion
2025-03-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06649942 on ClinicalTrials.gov