Menu
Recruiting NCT07712718

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

Phase I Interventional Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: [14C]-MRM-3379.
Who it may be relevant to
Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 55 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug [14C]-MRM-3379
    Oral capsule administered on Day 1 only.

Primary outcome measures

  • 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]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Fortrea Clinical Research Unit Inc — Madison

Identifiers

NCT: NCT07712718 · ENV-105

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗