Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06397872
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-07
First Post:
2024-04-30
Brief Title:
A Study to Evaluate the Pharmacokinetics Safety and Tolerability of Multiple Oral Doses 6 Days of 100 mg Resmetirom in Subjects With Severe Renal Impairment and in Matched Healthy Control Subjects With Normal Renal Function
Sponsor:
Madrigal Pharmaceuticals Inc
Organization:
Madrigal Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 1 Multi-center Open-label Study to Evaluate the Pharmacokinetics Safety and Tolerability of Multiple Oral Doses 6 Days of 100 mg Resmetirom in Subjects With Severe Renal Impairment and in Matched Healthy Control Subjects With Normal Renal Function
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to directly characterize the pharmacokinetic PK profiles of resmetirom and its major metabolite MGL-3623 following oral administration of 100 mg resmetirom QD x 6 days in subjects with severe renal impairment RI compared to healthy matched control subjects with normal renal function
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None