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This is a Phase 1, open label study in healthy male participants to study the Absorption, Distribution, Metabolism, and Excretion of [14C]-MRM-3379 drug following a single oral dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Male Volunteers | Experimental | Participants in this arm will receive a single dose of 5 mg [14C]-MRM-3379. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-MRM-3379 | Drug | Oral capsule administered on Day 1 only. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total radioactivity recovery of MRM-3379 in urine and feces | Evaluate the cumulative and total radioactivity in urine and feces following administration of a single oral dose of radiolabeled MRM-3379. | Up to 11 days post dose |
| Maximum observed concentration (Cmax) of MRM-3379 and 2 metabolites in plasma | Up to 11 days post dose | |
| Time to maximum observed concentration (tmax) of MRM-3379 and 2 metabolites in plasma | up to 11 days post dose | |
| Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-tlast) of MRM-3379 and 2 metabolites in plasma | up to 11 days post dose | |
| Maximum observed concentration (Cmax) of total radioactivity in plasma and whole blood | up to 11 days post dose | |
| Time to maximum observed concentration (tmax) of total radioactivity in plasma and whole blood | up to 11 days post dose | |
| Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-tlast) of total radioactivity in plasma and whole blood | Up to 11 days post dose | |
| Amount of MRM-3379 and 2 metabolites excreted in the urine (Ae) over sampling period | Up to 11 days post dose | |
| Fraction of MRM-3379 and 2 metabolites excreted in the urine (Fe) as Ae/dose |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of metabolites in plasma and excreta by liquid chromatography-radiochemical-detection and subsequent mass spectrometry | Evaluate the quantitative metabolic profile of MRM-3379 in plasma, urine, and feces via radiochromatographic profiles and identify associated metabolites following administration of a single oral dose of radiolabeled MRM-3379. | Up to 11 days post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Mirum | Contact | +16506674085 | Clinicaltrials@mirumpharma.com | |
| Medinfo Mirum | Contact | medinfo@mirumpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Kimberly Cruz, MD | Fortrea Clinical Research Unit Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit Inc | Recruiting | Madison | Wisconsin | 53704 | United States |
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| Up to 11 days post dose |
| Renal clearance of MRM-3379 as Ae/AUC | Up to 11 days post dose |
| Number of subjects with treatment-related adverse events | Up to 11 days post dose |