Healthy VolunteersPhase 1NCT07712718
A Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion of [14C]-MRM-3379
A Phase 1 study testing [14C]-MRM-3379 in people with Healthy Volunteers, run by Mirum Pharmaceuticals, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- [14C]-MRM-3379
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2026to 8 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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- Have previously completed or withdrawn from this trial or any other trial investigating MRM-3379 or have previously received MRM-3379.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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fortrea Clinical Research Unit Inc
Madison, Wisconsin, 53704
About this study
Official 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
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
- Being tested
- [14C]-MRM-3379
- Keywords
- MRM-3379, [14C]-MRM-3379, Mass balance, ADME
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-MRM-3379Drug
Also called MRM-3379
Oral capsule administered on Day 1 only.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Male Volunteers | Experimental | Participants in this arm will receive a single dose of 5 mg [14C]-MRM-3379. Receives: Drug: [14C]-MRM-3379 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 11 days post dose
Maximum observed concentration (Cmax) of MRM-3379 and 2 metabolites in plasma
Measured: Up to 11 days post dose
Time to maximum observed concentration (tmax) of MRM-3379 and 2 metabolites in plasma
Measured: 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
Measured: up to 11 days post dose
Maximum observed concentration (Cmax) of total radioactivity in plasma and whole blood
Measured: up to 11 days post dose
Time to maximum observed concentration (tmax) of total radioactivity in plasma and whole blood
Measured: 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
Measured: Up to 11 days post dose
Amount of MRM-3379 and 2 metabolites excreted in the urine (Ae) over sampling period
Measured: Up to 11 days post dose
Fraction of MRM-3379 and 2 metabolites excreted in the urine (Fe) as Ae/dose
Measured: Up to 11 days post dose
Renal clearance of MRM-3379 as Ae/AUC
Measured: 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
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.
Measured: Up to 11 days post dose
Number of subjects with treatment-related adverse events
Measured: Up to 11 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start29 May 2026
- Primary completion8 Jul 2026
- Study completion8 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mirum Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kimberly Cruz, MD, Principal investigator, Fortrea Clinical Research Unit Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712718
- Sponsor's protocol ID
- ENV-105
- Status last verified
- Oct 2026
- First submitted
- 26 Jun 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07712718
- Acronym / sponsor ID
- ENV-105
- Conditions
- Healthy Volunteers
- Keywords
- MRM-3379, [14C]-MRM-3379, Mass balance, ADME
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Mirum Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 May 2026 (actual)
- Primary completion
- 8 Jul 2026 (actual)
- Study completion
- 8 Jul 2026 (actual)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Male Volunteers | Experimental | Drug: [14C]-MRM-3379Participants in this arm will receive a single dose of 5 mg [14C]-MRM-3379. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]-MRM-3379Also: MRM-3379Oral capsule administered on Day 1 only. | Drug | Healthy Male Volunteers |
Primary outcome
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.
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
2 secondary outcomes
Assessment of metabolites in plasma and excreta by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Time frame: Up to 11 days post dose
Number of subjects with treatment-related adverse events
Time frame: Up to 11 days post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly Cruz, MD principal investigator
Fortrea Clinical Research Unit Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]-MRM-3379 in people with Healthy Volunteers, run by Mirum Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total radioactivity recovery of MRM-3379 in urine and feces (time frame: Up to 11 days post dose). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.