Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2026-01-02 @ 4:55 AM
Study NCT ID:
NCT04045769
Status:
COMPLETED
Last Update Posted:
2020-04-21
First Post:
2019-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effect of Saroglitazar Magnesium on the QTc Interval in Healthy Volunteers
Sponsor:
Zydus Therapeutics Inc.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: