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NCT Number: NCT07712718

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

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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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit Inc

Madison, Wisconsin, 53704, United States

Location status: Recruiting

Location contact

Hunter Walton

CONTACT

[email protected]

608-210-5454

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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  • Have previously completed or withdrawn from this trial or any other trial investigating MRM-3379 or have previously received MRM-3379.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

Treatment and study plan

[14C]-MRM-3379

Drug

Oral capsule administered on Day 1 only.

Other names: MRM-3379

Primary outcomes

  1. Total radioactivity recovery of MRM-3379 in urine and feces

    Time frame: Up to 11 days post dose

    Evaluate the cumulative and total radioactivity in urine and feces following administration of a single oral dose of radiolabeled MRM-3379.

  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

    Time frame: Up to 11 days post dose

    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.

  2. Number of subjects with treatment-related adverse events

    Time frame: Up to 11 days post dose

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Mirum

CONTACT

[email protected]

+16506674085

Medinfo Mirum

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Mirum Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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