NCT06649942

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

A Randomized, Single-blind, Placebo-controlled, Four-way Crossover Thorough QT Study to Investigate the Effect of KP-001 on the QT/QTc Interval Using Open-label Moxifloxacin as an Active Control, in Adult Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Kaken Pharmaceutical · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. The study will comprise the following: * Treatment Periods 1, 2, 3, and 4: For each period, participants will be residential at the Clinical Unit from the day before the dose of study intervention (Day 1 of each treatment period) until 3 days after the dose of study intervention (Day 4 of each treatment period). Participants will receive a single dose of study intervention each period, in accordance with the assigned treatment sequence . * Washout: at least 7 days between administrations of each study intervention. Total duration of study participation for each participant is approximately 8 weeks. On Day 1 of Treatment Period 1, participants will be randomly assigned in a 1:1:1:1 ratio to one of the four treatment sequences and administrated a single oral dose of one of the following four treatments under fasting condition: * KP-001 therapeutic dose (T): KP-001 100 mg + placebo * KP-001 supratherapeutic dose (ST): KP-001 400 mg * Placebo (P): placebo dry syrup * Moxifloxacin (M): moxifloxacin 400 mg tablet 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

Type	Name	Description
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

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-03-24
• Completion: 2025-03-24
• First posted: 2024-10-21
• Last updated: 2025-09-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study