NCT04112446

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

A Phase I, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Saroglitazar Following a Single Oral Dose of [14C]-Saroglitazar Magnesium in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Zydus Therapeutics Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the dose administration. Subjects will be admitted into the Clinical Research Unit (CRU) on Day -1 and be confined to the CRU until at least Day 8. On Day 1, subjects will receive a single oral dose of \[14C\]-saroglitazar magnesium. Subjects will be discharged if the following discharge criteria are met: plasma radioactivity levels below the limit of quantitation for 2 consecutive collections and ≥ 90% mass balance recovery, or ≤ 1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 3 consecutive 24-hour periods in which both are collected. If discharge criteria are not met by Day 8, subjects will remain in the CRU up to Day 12.

Conditions

• Healthy

Interventions

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

Timeline

• Start date: 2019-09-20
• Primary completion: 2019-10-29
• Completion: 2019-10-29
• First posted: 2019-10-02
• Last updated: 2019-11-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study