drugset / Trial / NCT05924815
Study to Evaluate the Effect of Aficamten Administration on QT/QTc Interval
RandomizedCrossoverDouble-blindBasic science
Summary
This is a single-center, 2-part (Part A and Part B) study in healthy participants. Part A (Dose Finding) is an open-label, SAD study to identify the dose for Part B. Part B (TQT Study) is a randomized, double-blind (with respect to aficamten and matching placebo), positive- and placebo-controlled, single-dose, 3-way crossover study to evaluate the effect of aficamten administration on QT/QTc interval.
Timeline
- Start
- 2023-05-15
- Primary completion
- 2023-11-14
- Completion
- 2023-11-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aficamten | Small molecule | 50 mg | Oral |
| Subject | Aficamten | Small molecule | 75 mg | Oral |
| Subject | Aficamten | Small molecule | 100 mg | Oral |
| Comparator | Moxifloxacin | Small molecule | 400 mg | Oral |
Indications
No indication recorded.