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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: Completed Phase 1 study, sponsored by Kaken Pharmaceutical.
NCT06649942 is a Phase 1 study that has completed, run by Kaken Pharmaceutical. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To evaluate the effect of KP-001 as single therapeutic and supratherapeutic dose on the QTcF interval
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 |
What the finished NCT06649942 record still lists
NCT06649942 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT06649942 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06649942's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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