A Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion of [14C]-MRM-3379

A Phase 1, Open-label, Trial of the Absorption, Distribution, Metabolism, and Excretion of [14C]-MRM-3379 Following a Single Oral Dose in Healthy Male Participants

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: [14C]-MRM-3379

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Clinical Trials Mirum; Phone Number: +16506674085; Email: clinicaltrials@mirumpharma.com
• Study Contact Backup: Name: Medinfo Mirum; Email: medinfo@mirumpharma.com

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Recruiting
      • Fortrea Clinical Research Unit Inc
      • Contact: Hunter Walton; Phone Number: 608-210-5454; Email: Hunter.Walton2@fortrea.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male of any race, between 18 and 55 years of age, inclusive.
2. Body mass index between 18.0 and 32.0 kg/m2, inclusive, and a body weight between 50 and 110 kg, inclusive.
3. In good health, as determined by medical history, and as assessed by the investigator (or designee).
4. Able to comprehend and are willing to sign the ICF and abide by the trial restrictions.

Exclusion Criteria:

1. History of or current medical condition that would place the participant at risk from study participation.
2. Administration of any vaccine within 30 days prior to dosing.
3. Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing, considered to potentially impact participant safety or the objectives of the trial, as determined by the investigator (or designee).
4. Participation in a clinical trial involving administration of an IMP (new chemical entity) in the past 30 days or 5 half-lives of that drug (if known) prior to dosing, whichever is longer.
5. Have previously completed or withdrawn from this trial or any other trial investigating MRM-3379 or have previously received MRM-3379.
6. Participants who have previously been dosed in >2 radiolabeled drug studies in the last 12 months. For participants who have previously been dosed in ≤2 radiolabeled drug studies within the last 12 months, the previous radiolabeled dose must be at least 4 months prior to check-in to the trial site where exposures are known to the investigator or 6 months prior to check-in to the trial site for a radiolabeled drug trial where exposures are not known to the investigator. The total 12-month exposure from this trial and a maximum of 2 other previous radiolabeled studies must be within the CFR recommended levels considered safe, per US Title 21 CFR 361.1.
7. Participants with exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
8. Participants who, in the opinion of the investigator (or designee), should not participate in this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Male Volunteers; Participants in this arm will receive a single dose of 5 mg [14C]-MRM-3379.	Drug: [14C]-MRM-3379; Oral capsule administered on Day 1 only.; Other Names: MRM-3379

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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		Up to 11 days post dose
Renal clearance of MRM-3379 as Ae/AUC		Up to 11 days post dose

Secondary Outcome Measures

Outcome Measure	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
Number of subjects with treatment-related adverse events		Up to 11 days post dose

Collaborators and Investigators

• Sponsor: Mirum Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Kimberly Cruz, MD, Fortrea Clinical Research Unit Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: June 26, 2026
• First Submitted That Met QC Criteria: July 14, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: ADME; Mass balance; MRM-3379; [14C]-MRM-3379
• Other Study ID Numbers: ENV-105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No