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NCT06649942 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Effects of KP-001 on the QT/QTc Intervals in Healthy Adults
A Phase 1 study, sponsored by Kaken Pharmaceutical.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT06649942 is a Phase 1 study that has completed, run by Kaken Pharmaceutical. The registered enrollment target is 40 participants.
The verdict
NCT06649942, a Phase 1 study, has completed, sponsored by Kaken Pharmaceutical.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
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.
Interventions
- DRUG Placebo
- DRUG Moxifloxacin 400 mg
- DRUG KP-001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-10-01 |
| Est. Completion | 2025-03-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06649942
The ClinicalTrials.gov registry entry for NCT06649942 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kaken Pharmaceutical, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT06649942 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06649942 about?
NCT06649942 is a clinical study titled "A Study to Evaluate the Effects of KP-001 on the QT/QTc Intervals in Healthy Adults". 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 volunteer...
What is the current status of trial NCT06649942?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2024-10-01. Estimated completion is 2025-03-24.
What interventions are being tested in trial NCT06649942?
The interventions under investigation include: Placebo (DRUG), Moxifloxacin 400 mg (DRUG), KP-001 (DRUG).
Who is sponsoring clinical trial NCT06649942?
This trial is sponsored by Kaken Pharmaceutical, which has 5 total clinical trials registered on ClinicalTrials.gov.
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