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Nacresertib

Phase 1

Healthy Volunteer | Small molecule | Other |AbbVie Inc.|Last Updated: Jul 23, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

Nacresertib · 3 trials · 2 indications

Phase 1 3
NCT07649954A Study to Evaluate How Multiple Doses of Itraconazole Interacts With Nacresertib in Healthy Adult ParticipantsHealthy Volunteer
RECRUITING12 Analytics
NCT07600762A Study to Assess Adverse Events, Tolerability and How a Single Oral Dose of Nacresertib Moves Through the Body In Healthy Adult Japanese ParticipantsHealthy Volunteer
COMPLETED12 Analytics
NCT07566130A Study to Assess Adverse Events, Tolerability and How Single and Ascending Oral Doses of Nacresertib Move Through the Body In Healthy Adult ParticipantsHealthy Volunteers
COMPLETED93 Analytics
PHASE1RECRUITING
A Study to Evaluate How Multiple Doses of Itraconazole Interacts With Nacresertib in Healthy Adult Participants
Healthy VolunteerUnlock trial analytics
PHASE1COMPLETED
A Study to Assess Adverse Events, Tolerability and How a Single Oral Dose of Nacresertib Moves Through the Body In Healthy Adult Japanese Participants
Healthy VolunteerUnlock trial analytics
PHASE1COMPLETED
A Study to Assess Adverse Events, Tolerability and How Single and Ascending Oral Doses of Nacresertib Move Through the Body In Healthy Adult Participants
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Observed Plasma Concentration (Cmax) of Nacresertib
Up to Day 12

Cmax of Nacresertib

Time to Cmax (Tmax) of Nacresertib
Up to Day 12

Tmax of Nacresertib

Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of Nacresertib
Up to Day 12

AUCt of Nacresertib

AUC From Time 0 to the Time Infinity (AUCinf) of Nacresertib
Up to Day 12

AUCinf of Nacresertib

Terminal Phase Elimination Rate Constant (Beta) of Nacresertib
Up to Day 12

Beta of Nacresertib

Terminal Phase Elimination Half-Life (t1/2) of Nacresertib
Up to Day 12

t1/2 of Nacresertib

Number of Participants Experiencing Adverse Events (AEs)
Up to 42 Days

Any untoward medical occurrence in a participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment

Part 2 Only: Area under the Plasma Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau) of nacresertib
Up to Day 14

AUCtau of nacresertib

Dose Normalized Cmax
Up to Day 19
Dose Normalized AUCs
Up to Day 19
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Period 1: Nacresertib OnlyEXPERIMENTALParticipant receives single dose of Nacresertib administered on Day 1
Period 2: Nacresertib and ItraconazoleEXPERIMENTALParticipant will receive itraconazole multiple times on Day 1, followed by a single dose of itraconazole on Days 2 through 11. Participants will also receive a single oral dose of Nacresertib on Day 4.
NacresertibEXPERIMENTALParticipants will receive a single dose of Nacresertib
Placebo for NacresertibPLACEBO_COMPARATORParticipants will receive a single dose of Placebo for Nacresertib
Part 1: Dose AEXPERIMENTALParticipants will receive a single dose of nacresertib or Placebo
Part 1: Dose BEXPERIMENTALParticipants will receive a single dose of nacresertib or Placebo
Part 1: Dose CEXPERIMENTALParticipants will receive a single dose of nacresertib or Placebo
Part 1: Dose DEXPERIMENTALParticipants will receive a single dose of nacresertib or Placebo
Part 1: Dose EEXPERIMENTALParticipants will receive a single dose of nacresertib or Placebo
Part 2: Dose FEXPERIMENTALParticipants will receive multiple doses of nacresertib or Placebo
Part 2: Dose GEXPERIMENTALParticipants will receive multiple doses of nacresertib or Placebo
Part 2: Dose HEXPERIMENTALParticipants will receive multiple doses of nacresertib or Placebo

Interventions

NameTypeDescription
NacresertibDRUGOral Tablet
ItraconazoleDRUGOral Capsule
Placebo for NacresertibDRUGOral tablet
PlaceboDRUGOral
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participants must voluntarily sign and date an informed consent, approved by an IEC/IRB, prior to the initiation of any screening or study-specific procedures. * Individuals 18 to 65 years of age at the time of screening. * Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m2 after...

Countries:United States
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Recent Changes (Last 90 Days)

MEDIUMAug 20, 2026NCT07600762TRIAL_REMOVED: changed
MEDIUMAug 20, 2026NCT07600762TRIAL_REMOVED: changed
MEDIUMAug 20, 2026NCT07600762TRIAL_REMOVED: changed
MEDIUMAug 20, 2026NCT07600762TRIAL_REMOVED: changed
LOWJul 24, 2026NCT07649954Status: NOT_YET_RECRUITING → RECRUITING
LOWJul 24, 2026NCT07649954Status: NOT_YET_RECRUITING → RECRUITING
HIGHJul 20, 2026NCT07600762Status: NOT_YET_RECRUITING → COMPLETED
HIGHJul 20, 2026NCT07600762Status: NOT_YET_RECRUITING → COMPLETED
MEDIUMJul 5, 2026NCT07566130TRIAL_REMOVED: changed
MEDIUMJul 5, 2026NCT07566130TRIAL_REMOVED: changed
MEDIUMJul 5, 2026NCT07566130TRIAL_REMOVED: changed
LOWJun 16, 2026NCT07649954NEW_TRIAL: changed
LOWJun 16, 2026NCT07649954NEW_TRIAL: changed
LOWJun 16, 2026NCT07649954NEW_TRIAL: changed

Frequently asked questions about Nacresertib

What is Nacresertib used for?

Nacresertib is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is in Phase 1 clinical development to assess its safety, tolerability, and how it moves through the body. Its intended therapeutic use has not been established.

Who makes Nacresertib?

Nacresertib is being developed by AbbVie Inc. (NYSE: ABBV). The company is conducting Phase 1 clinical trials to evaluate the drug's safety and pharmacokinetics in healthy adult participants.

What phase is Nacresertib in?

Nacresertib is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All ongoing and completed studies are early-stage trials in healthy volunteers.

What clinical trials is Nacresertib in?

Nacresertib has three Phase 1 trials. NCT07566130 and NCT07600762 are completed studies assessing single and ascending oral doses in healthy adults and Japanese participants. NCT07649954 is recruiting to evaluate how multiple doses of itraconazole interact with Nacresertib.

Is Nacresertib the same as any other drug?

No alternative names for Nacresertib have been reported. It is identified solely by its investigational name in clinical trial registries and is not known to be marketed under any other brand or chemical name.