Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Varegacestat Reference Formulation
Varegacestat · 5 trials · 3 indications
AUC0-t varegacestat and metabolite
AUC0-t for varegacestat administered with and without itraconazole.
| Arm | Type | Description |
|---|---|---|
| Reference Formulation, then Test Formulation | EXPERIMENTAL | - |
| Test Formulation, then Reference Formulation | EXPERIMENTAL | - |
| Treatment Arm | EXPERIMENTAL | Single oral dose of varegacestat administered on study day 1 |
| Drug: varegacestat | EXPERIMENTAL | Single oral dose of varegacestat administered on study Day 1 |
| Varegacestat | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Moxifloxacin | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Varegacestat Reference Formulation | DRUG | Oral administration |
| Varegacestat Test Formulation | DRUG | Oral administration |
| varegacestat | DRUG | experimental intervention |
| Placebo | DRUG | Single oral dose of placebo |
| Moxifloxacin 400 mg | DRUG | Single oral dose of moxifloxacin |
| Itraconazole (200 mg) | DRUG | Intervention to evaluate DDI with experimental intervention |
Inclusion Criteria: * Healthy, adult, female of non childbearing potential or male, 18 to 55 years of age, inclusive, at the screening visit * Male participants must follow protocol-specified contraception guidance * Continuous non-smoker who has not used nicotine and tobacco containing products fo...
Varegacestat Reference Formulation is an investigational small molecule being studied in healthy volunteers. It is being evaluated in Phase 1 clinical trials to assess its bioavailability, bioequivalence, cardiac liability, mass balance, and effects in people with hepatic impairment. It is not approved for any disease and remains in early clinical development.
Varegacestat Reference Formulation targets gamma-secretase, an enzyme involved in protein processing. As a gamma-secretase inhibitor, it is being studied in healthy participants to understand its pharmacokinetic and safety profile. The drug is in Phase 1 development by Immunome, Inc.
Varegacestat Reference Formulation is being developed by Immunome, Inc., a biopharmaceutical company traded on NASDAQ under the ticker IMNM. The company is conducting Phase 1 clinical trials of this investigational small molecule in healthy volunteers in the United States.
Varegacestat Reference Formulation is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Four Phase 1 trials have been conducted, with one currently recruiting and three completed, all involving healthy participants.
Varegacestat Reference Formulation has four Phase 1 trials. NCT07610005 is a recruiting relative bioavailability and bioequivalence study in 20 healthy participants. NCT06855264 is a completed cardiac liability study in 32 participants. NCT06845852 is a completed mass balance study in 6 males. NCT06841315 is a completed hepatic impairment study in 35 participants.
Varegacestat Reference Formulation is a specific formulation of the drug varegacestat, developed by Immunome, Inc. It is being tested in healthy volunteers to evaluate its bioavailability, cardiac safety, mass balance, and effects in hepatic impairment. The reference formulation is the version used in these Phase 1 clinical trials.