A Study to Evaluate the Effect of Saroglitazar Magnesium on the QTc Interval in Healthy Volunteers

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2019
Primary Objective: This is a Phase 1, single‐center, blinded (with respect to saroglitazar magnesium and placebo administration), randomized, placebo‐ and active‐controlled, 4‐period crossover study to investigate the effect of single therapeutic and supra‐therapeutic (5×) doses of saroglitazar magnesium on the corrected QT (QTc) interval in healthy subjects in compliance with the current version of the International Council for Harmonisation E14 Guidelines. After confirmation of eligibility, 52 subjects (at least 16 will be females) will be randomly assigned to 1 of 4 treatment sequences using a William's design prior to study treatment administration on Day 1 of Period 1. Randomized subjects will receive each of the 4 study treatments across the 4 treatment periods separated by at least a 7‐day washout period.
Epistemonikos ID: 5dc2c75384a797410b9de1e04b7b567cb2e81295
First added on: May 22, 2024