NCT04045769

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

A Single-center, Randomized, Blinded, Placebo- and Active-controlled Crossover Study to Evaluate the Effect of Saroglitazar Magnesium on the QTc Interval in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Zydus Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A Single-center, Randomized, Blinded, Placebo- and Active-controlled Crossover Study to Evaluate the Effect of Saroglitazar Magnesium on the QTc Interval in Healthy Volunteers

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Saroglitazar magnesium 4mg	1 tablet of 4 mg Saroglitazar magnesium; 4 tablets of placebo to be administered orally
DRUG	Placebos	5 tablets of placebo to be administered orally
DRUG	Moxifloxacin 400mg	1 tablet of 400 mg Moxifloxacin to be administered orally
DRUG	Saroglitazar magnesium 20 mg	5 tablets of 4 mg Saroglitazar magnesium to be administered orally

Timeline

• Start date: 2019-08-19
• Primary completion: 2019-11-27
• Completion: 2019-12-02
• First posted: 2019-08-06
• Last updated: 2020-04-21

Locations

1 site across 1 country: India

Regulatory

• FDA-regulated drug study