A Study to Investigate the Effects of Multiple Doses of Rezatapopt on the Pharmacokinetics of Metformin, Rosuvastatin, Repaglinide, and Midazolam in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation.
← catalyst calendarNCT07372625 · readout ≤ 224 d
Sponsored by PMV Pharmaceuticals, Inc (industry) · PMVP — their whole pipeline →. With SCRI Development Innovations, LLC.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
14estimated
Sites
5
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-02-04 | actual | When the study began enrolling |
| Primary completion | Mar 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jan 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2026-01-28 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-12 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- TP53 Y220C Mutation
- Advanced Solid Tumors
Interventions
- Drug: metformin hydrochloride 500 mg tablet
- Drug: rosuvastatin 10 mg tablet
- Drug: repaglinide 0.5 mg tablet
- Drug: midazolam hydrochloride syrup
- Drug: rezatapopt
Primary outcomes
what the primary-completion date above is the date OFMetformin Cmax geometric mean ratio
measured Day 1 to Day 24 of Part A
Rosuvastatin Cmax geometric mean ratio
measured Day 1 to Day 24 of Part A
Repaglinide Cmax geometric mean ratio
measured Day 1 to Day 24 of Part A
Midazolam Cmax geometric mean ratio
measured Day 1 to Day 24 of Part A
Metformin AUC0-t geometric mean ratio
measured Day 1 to Day 24 of Part A
Rosuvastatin AUC0-t geometric mean ratio
measured Day 1 to Day 24 of Part A
Repaglinide AUC0-t geometric mean ratio
measured Day 1 to Day 24 of Part A
Midazolam AUC0-t geometric mean ratio
measured Day 1 to Day 24 of Part A
PK profile of metformin - area under the concentration-time curve from pre-dose (time 0) to 24 h post-dose (AUC0-24)
measured Day 1 to Day 24 of Part A
PK profile of rosuvastatin - area under the concentration-time curve from pre-dose (time 0) to 24 h post-dose (AUC0-24)
measured Day 1 to Day 24 of Part A
PK profile of repaglinide - area under the concentration-time curve from pre-dose (time 0) to 24 h post-dose (AUC0-24)
measured Day 1 to Day 24 of Part A
PK profile of midazolam - area under the concentration-time curve from pre-dose (time 0) to the time 24 h post-dose (AUC0-24)
measured Day 1 to Day 24 of Part A
PK profile of metformin - area under the concentration-time curve from pre-dose (time 0) to 48 h post-dose (AUC0-48)
measured Day 1 to Day 24 of Part A
PK profile of rosuvastatin - area under the concentration-time curve from pre-dose (time 0) to 48 h post-dose (AUC0-48)
measured Day 1 to Day 24 of Part A
PK Profile of Metformin - Time of Peak Concentration (Tmax)
measured Day 1 to Day 24 of Part A
PK Profile of Rosuvastatin - Time of Peak Concentration (Tmax)
measured Day 1 to Day 24 of Part A
PK Profile of Repaglinide - Time of Peak Concentration (Tmax)
measured Day 1 to Day 24 of Part A
PK Profile of Midazolam - Time of Peak Concentration (Tmax)
measured Day 1 to Day 24 of Part A
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