Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Severe renal impairment | Experimental |
| |
| Normal Healthy Match | Experimental | Matched to severe renal impairment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 100 mg Resmetirom Tablet | Drug | Once daily oral dose for 6 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma pharmacokinetics - Cmax | Cmax after administration | 8 days |
| Plasma pharmacokinetics - Tmax | Tmax after administration | 8 days |
| Plasma pharmacokinetics - AUC(0-Last) | AUC(0-Last) after administration | 8 days |
| Plasma pharmacokinetics - t1/2 | t1/2 after administration | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on the incidence of adverse events | 13 days |
Not provided
Inclusion Criteria:
Subjects with Severe Renal Impairment
Matched Healthy Control Subjects
Exclusion Criteria:
All Subjects
Subjects with Severe Renal Impairment
Healthy Matched Control Subjects
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Geoff Rezvani | Madrigal Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madrigal Research Center | Orlando | Florida | 32809 | United States | ||
| Madrigal Research Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tampa |
| Florida |
| 33603 |
| United States |
| Madrigal Research Center | Chicago | Illinois | 60643 | United States |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C588408 | resmetirom |
Not provided
Not provided
Not provided