CClinicalTrials.gg
Sign In
RecruitingNCT07712718Updated Jul 17, 2026

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

A Phase 1 interventional study of [14C]-MRM-3379 in Healthy Volunteers, sponsored by Mirum Pharmaceuticals, Inc.. Recruiting at 1 site in United States. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-17.

Sponsored by Mirum Pharmaceuticals, Inc. · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • MRM-3379
  • [14C]-MRM-3379
  • Mass balance
  • ADME
03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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 Have previously completed or withdrawn from this trial or any other trial investigating MRM-3379 or have previously received MRM-3379.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.
04

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (estimated)

Study arms

  • Experimental
    Healthy Male Volunteers

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

    Drug: [14C]-MRM-3379

Interventions

  • Drug[14C]-MRM-3379

    Oral capsule administered on Day 1 only.

    Also known as: MRM-3379

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 11 days post dose

  2. Maximum observed concentration (Cmax) of MRM-3379 and 2 metabolites in plasma

    Time frame: Up to 11 days post dose

  3. Time to maximum observed concentration (tmax) of MRM-3379 and 2 metabolites in plasma

    Time frame: up to 11 days post dose

  4. 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

  5. Maximum observed concentration (Cmax) of total radioactivity in plasma and whole blood

    Time frame: up to 11 days post dose

  6. Time to maximum observed concentration (tmax) of total radioactivity in plasma and whole blood

    Time frame: up to 11 days post dose

  7. 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

  8. Amount of MRM-3379 and 2 metabolites excreted in the urine (Ae) over sampling period

    Time frame: Up to 11 days post dose

  9. Fraction of MRM-3379 and 2 metabolites excreted in the urine (Fe) as Ae/dose

    Time frame: Up to 11 days post dose

  10. Renal clearance of MRM-3379 as Ae/AUC

    Time frame: Up to 11 days post dose

Secondary outcomes

  1. 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.

    Time frame: Up to 11 days post dose

  2. Number of subjects with treatment-related adverse events

    Time frame: Up to 11 days post dose

06

Study locations

1 of 1 sites recruiting
  • Fortrea Clinical Research Unit Inc
    Madison, Wisconsin 53704, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07712718
Lead sponsor
Mirum Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Jul 17, 2026
Start date
May 29, 2026
Primary completion
Jul 2026 (estimated)
Completion
Jul 2026 (estimated)
Last update
Jul 17, 2026

Study contacts

Clinical Trials Mirum
Contact
Clinicaltrials@mirumpharma.com
+16506674085
Medinfo Mirum
Contact
medinfo@mirumpharma.com
Kimberly Cruz, MD
principal investigator · Fortrea Clinical Research Unit Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Mirum Pharmaceuticals, Inc.

Start the discussion