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

NCT04045769 | Completed Phase 1 FDA Drug

• 1 other identifier: SARO.17.006
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• QTcF change-from-baseline

  Linear-mixed model will be used to assess the effect of saroglitazar magnesium on cardiac repolarization on Day 1 to evaluate whether saroglitazar magnesium prolongs the QTcF when orally administered to healthy volunteers

  Pre-dose (-1.0 hr) to 24 hours post dose

• Saroglitazar and its metabolite saroglitazar sulfoxide plasma concentrations and placebo-corrected change-from-baseline QTcF

  Quantification of the relationship between saroglitazar and its metabolite saroglitazar sulfoxide plasma concentrations and QTcF, using concentration-effect modeling

  Pre-dose (-1.0 hr) to 24 hours post dose

Secondary Outcomes (1)

• Observed and change-from-baseline HR, PR, RR, QRS, and QT and ECG morphological abnormalities

  Pre-dose (-1.0 hr) to 24 hours post dose

Study Arms (4)

Study Treatment 1

EXPERIMENTAL

Saroglitazar magnesium 4 mg

Drug: Saroglitazar magnesium 4mg

Study treatment 2

EXPERIMENTAL

Saroglitazar magnesium 20 mg

Drug: Saroglitazar magnesium 20 mg

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebos

Active Control

ACTIVE COMPARATOR

Moxifloxacin 400 mg

Drug: Moxifloxacin 400mg

Interventions

Saroglitazar magnesium 4mg DRUG

1 tablet of 4 mg Saroglitazar magnesium; 4 tablets of placebo to be administered orally

Also known as: not any

Study Treatment 1

Placebos DRUG

5 tablets of placebo to be administered orally

Also known as: not any

Placebo

Moxifloxacin 400mg DRUG

1 tablet of 400 mg Moxifloxacin to be administered orally

Also known as: not any

Active Control

Saroglitazar magnesium 20 mg DRUG

5 tablets of 4 mg Saroglitazar magnesium to be administered orally

Also known as: not any

Study treatment 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of signed and dated written informed consent prior to any study-specific procedures
• Willing and able to comply with the study procedures, restrictions, and requirements.
• At least (≥) 18 years of age and no more than (≤) 45 years of age a
• Body mass index of 19.0 to 25.0 kg/m² (inclusive) with a body weight of 50 to 100 kg
• non-smokers and must not drink alcohol (teetotal).
• Subjects who, in the opinion of the Investigator, are healthy as determined by their pre-study medical history, physical examination, and 12-lead ECG, and clinical laboratory tests within the institutional normal range or judged as not clinically significant by the Investigator, including the following parameters: hematology, serum biochemistry, urinalysis, and serology.
• Male subjects and female subjects of childbearing potential must practice highly effective contraception during the study and be willing and able to continue contraception for 90 days after their last administration of study treatment.
• Systemic blood pressure with a systolic blood pressure of 100 to 140 mmHg and a diastolic blood pressure of 60 to 90 mmHg.

You may not qualify if:

• History of cardiovascular disease (eg, hypertension, arrhythmia, heart failure, long QT syndrome, or other conditions/diseases causing prolongation of the QT/QTc interval), in the opinion of the Investigator.
• A prolongation of the QT interval corrected for HR using Fridericia's correction (QTcF) interval (eg, repeated demonstration of a QTcF interval \>450 msec) before study treatment administration.
• Any clinically important abnormalities in the ECG at screening, check-in (Day -1), or predose on Day 1. This includes subjects with any of the following:
• PR interval \>210 msec;
• QRS \>110 msec; or
• HR \<45 beats per minute (bpm) or \>100 bpm.
• A QRS and/or T-wave value that the Investigator judges to be unfavorable for consistently accurate QT measurements (eg, indistinct QRS onset, low amplitude T-wave, inverted or terminally-inverted T-wave, merged T/U-waves, indistinct T-wave offset, or prominent U-wave that affects QT measurement).
• History of additional risk factors for Torsades de Pointes or the presence of a family history of short QT syndrome, long QT syndrome, sudden unexplained death at a young age (≤40 years), drowning or sudden infant death syndrome in a first degree relative (ie, biological parent, sibling, or child).
• Use of medications in the 90 days before Day -1 of Period 1 that are known to prolong the QT/QTc interval.
• Has used prescription drugs and other substances (eg, dietary or herbal supplements such as St John's Wort) known to be either significant enzyme inducers or enzyme inhibitors within 4 weeks of Day 1 of Period 1, or use of grapefruit or similar substances (Seville oranges or marmalade, grapefruit juice, grapefruit hybrids, pomelos, exotic citrus fruits or fruit juices) within 7 days of Day 1 of Period 1.
• Has used prescription or over-the-counter medication, excluding routine vitamins but including megadose vitamin therapy (intake of 20 to 600 times the recommended daily dose), within 7 days of Day 1 of Period 1, unless agreed as not clinically relevant by the Investigator and Sponsor.
• Any history of malignant disease, including solid tumors, hematologic malignancies, and including any carcinoma in situ.
• Clinically significant allergies, as determined by the Investigator.
• History of any clinically significant endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major diseases, as determined by the Investigator.
• History of unexplained syncopal or hypotensive episodes.

Sponsors & Collaborators

• Zydus Therapeutics Inc.: lead

Study Sites (1)

Cliantha Research Limited

Ahmedabad, Gujarat, 380 054, India

Location

MeSH Terms

Interventions

saroglitazar; Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Dr. Deven V Parmar, MD,FCP

  Zydus Therapeutics Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 6, 2019
• Study Start: August 19, 2019
• Primary Completion: November 27, 2019
• Study Completion: December 2, 2019
• Last Updated: April 21, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)