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

NCT07712718 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ENV-105
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

MRM-3379; [14C]-MRM-3379; Mass balance; ADME

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (2)

• Assessment of metabolites in plasma and excreta by liquid chromatography-radiochemical-detection and subsequent mass spectrometry

  Up to 11 days post dose

• Number of subjects with treatment-related adverse events

  Up to 11 days post dose

Study Arms (1)

Healthy Male Volunteers

EXPERIMENTAL

Participants in this arm will receive a single dose of 5 mg \[14C\]-MRM-3379.

Drug: [14C]-MRM-3379

Interventions

[14C]-MRM-3379 DRUG

Oral capsule administered on Day 1 only.

Also known as: MRM-3379

Healthy Male Volunteers

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• History of or current medical condition that would place the participant at risk from study participation.
• Administration of any vaccine within 30 days prior to dosing.
• 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).
• 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.
• Have previously completed or withdrawn from this trial or any other trial investigating MRM-3379 or have previously received MRM-3379.
• 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.
• 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.
• Participants who, in the opinion of the investigator (or designee), should not participate in this trial.

Sponsors & Collaborators

• Mirum Pharmaceuticals, Inc.: lead

Study Sites (1)

Fortrea Clinical Research Unit Inc

Madison, Wisconsin, 53704, United States

RECRUITING

Study Officials

• Kimberly Cruz, MD

  Fortrea Clinical Research Unit Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Mirum

CONTACT

+16506674085; Clinicaltrials@mirumpharma.com

Medinfo Mirum

CONTACT

medinfo@mirumpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 17, 2026
• Study Start: May 29, 2026
• Primary Completion: July 1, 2026
• Study Completion: July 1, 2026
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)