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Study to Evaluate Absorption, Metabolism and Excretion of Single-dose [14C]-Saroglitazar in Healthy Male Subjects

NCT04112446 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-11-13

No results posted yet for this study

Summary

This will be a Phase I, open-label, nonrandomized, single-dose study in healthy male subjects.

Conditions

  • Healthy

Interventions

DRUG

Saroglitazar magnesium

On Day 1, subjects will receive a single oral dose of \[14C\]-saroglitazar magnesium

Sponsors & Collaborators

  • Zydus Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • John E. Blanchard, MD · Covance

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-20
Primary Completion
2019-10-29
Completion
2019-10-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04112446 on ClinicalTrials.gov