A Study to Assess Adverse Events, Tolerability and How Single and Ascending Oral Doses of Nacresertib Move Through the Body In Healthy Adult Participants
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · Triple · Basic science
Enrollment
93actual
Sites
1
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 | 2025-04-18 | actual | When the study began enrolling |
| Primary completion | 2026-05-07 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-05-07 | actual | The whole study's end, after follow-up |
| First posted | 2026-05-04 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-04 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Healthy Volunteers
Interventions
- Drug: nacresertib
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFMaximum Observed Plasma Concentration (Cmax) of nacresertib
measured Up to Day 19
Time to Cmax (Tmax) of nacresertib
measured Up to Day 19
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of nacresertib
measured Up to Day 19
AUC From Time 0 to the Time Infinity (AUCinf) of nacresertib
measured Up to Day 19
Part 2 Only: Area under the Plasma Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau) of nacresertib
measured Up to Day 14
Terminal Phase Elimination Rate Constant (Beta) of nacresertib
measured Up to Day 19
Terminal Phase Elimination Half-Life (t1/2) of nacresertib
measured Up to Day 19
Dose Normalized Cmax
measured Up to Day 19
Dose Normalized AUCs
measured Up to Day 19
Number of Participants Experiencing Adverse Events (AEs)
measured 74 Days
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