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Also known as [14C]-MRM-3379, MRM-3379
Low dose of MRM-3379 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1: Low Dose of MRM-3379 | EXPERIMENTAL | Participants 16-45 years of age randomized to this arm will receive the low dose of MRM-3379 |
| Arm 2: Middle dose of MRM-3379 | EXPERIMENTAL | Participants 16-45 years of age randomized to this arm will receive the middle dose of MRM-3379 |
| Arm 3: High dose of MRM-3379 | EXPERIMENTAL | Participants 16-45 years of age randomized to this arm will receive the high dose of MRM-3379 |
| Arm 4 :Placebo | PLACEBO_COMPARATOR | Participants 16-45 years of age randomized to this arm will receive Placebo |
| Arm 5: Low dose of MRM-3379 Open-Label | EXPERIMENTAL | Participants 13 to \< 16 years of age will receive the low dose of MRM-3370 Open-Label |
| Name | Type | Description |
|---|---|---|
| Low dose of MRM-3379 | DRUG | Oral capsule |
| Middle Dose of MRM-3379 | DRUG | Oral capsule |
| High dose of MRM-3379 | DRUG | Oral capsule |
| Placebo | DRUG | Capsules matched to study drug without the active pharmaceutical ingredient |
| Low dose of MRM-3379 Open-Label | DRUG | Oral capsule |
Inclusion Criteria: * Willing and able to provide signed informed consent/assent. Where local regulations permit inclusion of participants deemed unable to provide informed consent, a legally authorized representative must provide informed consent on the participant's behalf, and the participant mu...
MRM-3379 is an investigational small molecule being studied for Fragile X Syndrome, a rare genetic condition. It is currently in Phase 2 clinical development, with an active trial evaluating its effects in male participants aged 13 years and older with Fragile X Syndrome.
MRM-3379 targets PDE4D, an enzyme involved in cellular signaling pathways. By inhibiting PDE4D, the drug aims to modulate these pathways, which may be relevant to the treatment of Fragile X Syndrome.
MRM-3379 is being developed by Mirum Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol MIRM. The company is conducting clinical trials to evaluate the drug's safety and efficacy.
MRM-3379 is in Phase 2 clinical development for Fragile X Syndrome. It is also being studied in a Phase 1 trial in healthy volunteers to evaluate its absorption, distribution, metabolism, and excretion. The drug is investigational and not yet approved.
MRM-3379 is being studied in two clinical trials. NCT07209462 is a Phase 2 study in male participants with Fragile X Syndrome, and NCT07712718 is a Phase 1 study of [14C]-MRM-3379 in healthy male volunteers to assess its pharmacokinetics.
MRM-3379 and [14C]-MRM-3379 are related forms of the same drug. [14C]-MRM-3379 is a radiolabeled version used in a Phase 1 study to track the drug's absorption, distribution, metabolism, and excretion in healthy volunteers.