NCT04446507

A Pharmacokinetic Study of Saroglitazar Magnesium in Subjects with Severe Renal Impairment and Normal Renal Function

A Phase 1, Open-label Study to Evaluate the Pharmacokinetics and Safety of Saroglitazar Magnesium in Participants with Normal Renal Function and Participants with Severe Renal Impairment.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Zydus Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This will be a Phase 1, Open-label Study of Participants with Normal Renal Function and Participants with Sever Renal Impairment.

Detailed description

A total of 32 participants will be enrolled: Group 1 (Severe renal impairment not on HD, eGFR \<30) - 16 subjects Subjects will be enrolled and dosed consecutively (i.e. first 8 subjects of group 1 will receive 2 mg dose, followed by another 8 subjects who will receive 4 mg dose). Group 2 (Normal renal function eGFR ≥90) - 16 subjects Subjects in this group will be matched according to age (± 10 years), sex, and weight (± 20 kg) with participants in Group 1 (Severe renal impairment not on HD) on a one to one basis based on demographic characteristic. In this group, 8 participants will be administered single dose of 2 mg Saroglitazar Magnesium and 8 participants will be administered single dose of 4 mg Saroglitazar Magnesium. To match the older population ranging from 65 years and above in the control group, the eGFR requirement can be set to 70 or above (by MDRD formula) without any signs of kidney damage (like proteinuria) and are otherwise healthy as per the investigator's discretion

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	Saroglitazar magnesium	1 dose of 2mg and 4 mg Saroglitazar magnesium will be given to subjects on Day 1

Timeline

• Start date: 2020-07-27
• Primary completion: 2024-05-28
• Completion: 2024-05-28
• First posted: 2020-06-25
• Last updated: 2024-09-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study