Recruiting
Phase 1

MRM-3379

Sponsor:

Mirum Pharmaceuticals, Inc.

Code:

NCT07712718

Conditions

Healthy Volunteers

Eligibility Criteria

Sex: Male

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

[14C]-MRM-3379

Study Details

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

Study ID

NCT07712718

Start date

May 29, 2026

Status verified date

Jul, 2026

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 55

Healthy Volunteers: Accepted

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 Have previously completed or withdrawn from this trial or any other trial investigating MRM-3379 or have previously received MRM-3379.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 Design

Enrollment

8 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Healthy Male Volunteers

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

Interventions

[14C]-MRM-3379

Oral capsule administered on Day 1 only.

Primary outcome measure

  • Total radioactivity recovery of MRM-3379 in urine and feces [ Time Frame: Up to 11 days post dose ]
  • Maximum observed concentration (Cmax) of MRM-3379 and 2 metabolites in plasma [ Time Frame: Up to 11 days post dose ]
  • Time to maximum observed concentration (tmax) of MRM-3379 and 2 metabolites in plasma [ Time Frame: 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 [ Time Frame: up to 11 days post dose ]
  • Maximum observed concentration (Cmax) of total radioactivity in plasma and whole blood [ Time Frame: up to 11 days post dose ]
  • Time to maximum observed concentration (tmax) of total radioactivity in plasma and whole blood [ Time Frame: 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 [ Time Frame: Up to 11 days post dose ]
  • Amount of MRM-3379 and 2 metabolites excreted in the urine (Ae) over sampling period [ Time Frame: Up to 11 days post dose ]
  • Fraction of MRM-3379 and 2 metabolites excreted in the urine (Fe) as Ae/dose [ Time Frame: Up to 11 days post dose ]
  • Renal clearance of MRM-3379 as Ae/AUC [ Time Frame: Up to 11 days post dose ]

Central Contacts and Locations

Central contacts

Locations

Fortrea Clinical Research Unit Inc

Recruiting

Madison, Wisconsin, United States, 53704

Contacts

More Information

Sponsor

Mirum Pharmaceuticals, Inc.

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mirum Pharmaceuticals, Inc. on 2026-07-17.