Electrophysiological Effects of Potential QT Prolonging Drugs
Status:
Not yet recruiting
Trial end date:
2023-05-01
Target enrollment:
Participant gender:
Summary
Since 2005, FDA has required almost all new drugs be tested for their ability to prolong the
QT interval through clinical studies. This requirement stems from the increased TdP risk QT
interval prolongation can cause. However, the QT interval is an imperfect biomarker, as there
are multiple drugs that can prolong the QT interval, without causing increased TdP
occurrence. As such, numerous drugs labeled as causing QT prolongation, may in fact have no
impact on TdP occurrence.
To address this problem, FDA, in collaboration with multiple external partners, has led an
initiative to combine novel preclinical in vitro experiments within silico modeling and
simulation followed by pharmacodynamic electrocardiographic (ECG) biomarkers. The goal is to
use these novel computational and analytical tools to better predict TdP risk (beyond just
the QT interval) by focusing on understanding the underlying mechanisms and applying an
integrated biological systems approach.
This clinical study consists of 2 parts: a 3-arm, 22-subject crossover study (Part 1) and a
4-arm, 22-subject crossover study (Part 2). These parts are included in the same protocol and
study due to the similarity of the inclusion and exclusion criteria, similar procedures, and
similar primary goals.
Phase:
Phase 1
Details
Lead Sponsor:
Food and Drug Administration (FDA)
Collaborator:
Spaulding Clinical Research LLC
Treatments:
Clarithromycin Cobicistat Moxifloxacin Norgestimate, ethinyl estradiol drug combination Pimozide