A Study to Evaluate the Effects of KP-001 on the QT/QTc Intervals in Healthy Adults
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.
Timeline
- Start
- 2024-10-01
- Primary completion
- 2025-03-24
- Completion
- 2025-03-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | KP-001 | Unknown | 100 mg | Oral |
| Subject | KP-001 | Unknown | 400 mg | Oral |
| Comparator | Moxifloxacin | Small molecule | 400 mg | Oral |
Indications
No indication recorded.