A Pharmacokinetic Study of Saroglitazar Magnesium in Subjects With Severe Renal Impairment and Normal Renal Function
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Renal Impairment
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
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 ren...
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 (± 10 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.
Tracking Information
- NCT #
- NCT04446507
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Dr. Eric Lawitz, MD American Research Corporation @ Texas Liver Institute
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