Celerion, Inc 2420
Tempe, Arizona, 85283, United States
NCT Number: NCT05924815
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.
Looking for future studies?
Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Tempe, Arizona, 85283, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral Tablet
Oral Tablet
Oral Tablet
Time frame: Baseline to End of Study, up to 8 weeks
To determine the dose for Part B based on Part A PK and safety data.
Time frame: Baseline to End of Study, up to 14.5 weeks
To evaluate the effect of a single oral dose of aficamten on the QTc interval in healthy participants.
Time frame: Baseline to End of Study, up to 14.5 weeks
To demonstrate assay sensitivity of the study to detect a small QTc effect using moxifloxacin as a positive control in healthy participants.
Cytokinetics
Industry
A Randomized, 2-Part, Single-Dose, Crossover Study to Evaluate the Effect of Aficamten Administration on QT/QTc Interval in Healthy Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05870072
Balance, Postural, Behavior
Kütahya, Centre, Turkey (Türkiye)
View Trial DetailsNCT07241065
Healthy Participants
Berlin, Germany
View Trial DetailsNCT07214766
Healthy Participants
Anaheim, California, United States
View Trial DetailsNCT07444424
Body Weight, Diabetes Mellitus
Fukuoka, Japan
View Trial Details