Healthy VolunteerPhase 1NCT07600762
A Study to Assess Adverse Events, Tolerability and How a Single Oral Dose of Nacresertib Moves Through the Body In Healthy Adult Japanese Participants
A Phase 1 study testing Nacresertib in people with Healthy Volunteer, run by AbbVie at 1 site in United States.
Trial summary
A Study to Assess Adverse Events, Tolerability and How a Single Oral Dose of Nacresertib Moves Through the Body In Healthy Adult Japanese Participants Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Nacresertib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2026to 17 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Japanese male or female; 18 to 65 years of age at the time of screening.
- Japanese participant must be first-or second-generation Japanese of full Japanese parentage. First-generation participants will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent.
- BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenth decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
Who cannot join
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- History of any clinically significant sensitivity or allergy to any medication or food.
- History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption [e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.].
Trial locations and contacts
1 site in 1 country.
United States1 site
CenExel ACT- Anaheim Clinical Trials /ID# 282482
Anaheim, California, 92801
About this study
Official title: A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Nacresertib in Healthy Adult Japanese Subjects
A Study to Assess Adverse Events, Tolerability and How a Single Oral Dose of Nacresertib Moves Through the Body In Healthy Adult Japanese Participants
- Conditions
- Healthy Volunteer
- Being tested
- Nacresertib, Placebo for Nacresertib
- Keywords
- Healthy Volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NacresertibDrug
Oral tablet
Placebo for NacresertibDrug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Nacresertib | Experimental | Participants will receive a single dose of Nacresertib Receives: Drug: Nacresertib |
| Placebo for Nacresertib | Placebo comparator | Participants will receive a single dose of Placebo for Nacresertib Receives: Drug: Placebo for Nacresertib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of Nacresertib
Cmax of Nacresertib
Measured: Up to 9 Days
Time to Cmax (Tmax) of Nacresertib
Tmax of Nacresertib
Measured: Up to 9 Days
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of Nacresertib
AUCt of Nacresertib
Measured: Up to 9 Days
AUC From Time 0 to the Time Infinity (AUCinf) of Nacresertib
AUCinf of Nacresertib
Measured: Up to 9 Days
Terminal Phase Elimination Rate Constant (Beta) of Nacresertib
Beta of Nacresertib
Measured: Up to 9 Days
Terminal Phase Elimination Half-Life (t1/2) of Nacresertib
t1/2 of Nacresertib
Measured: Up to 9 Days
Number of Participants Experiencing Adverse Events (AEs)
Any untoward medical occurrence in a participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment
Measured: Up to 42 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start21 Apr 2026
- Primary completion17 Jun 2026
- Study completion17 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600762
- Sponsor's protocol ID
- M25-765
- Status last verified
- Jul 2026
- First submitted
- 14 May 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Nacresertib in Healthy Adult Japanese Subjects
- ClinicalTrials.gov ID
- NCT07600762
- Acronym / sponsor ID
- M25-765
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- 17 Jun 2026 (actual)
- Study completion
- 17 Jun 2026 (actual)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Study to Assess Adverse Events, Tolerability and How a Single Oral Dose of Nacresertib Moves Through the Body In Healthy Adult Japanese Participants
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nacresertib | Experimental | Drug: NacresertibParticipants will receive a single dose of Nacresertib |
| Placebo for Nacresertib | Placebo comparator | Drug: Placebo for NacresertibParticipants will receive a single dose of Placebo for Nacresertib |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy Japanese male or female; 18 to 65 years of age at the time of screening.
- Japanese participant must be first-or second-generation Japanese of full Japanese parentage. First-generation participants will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent.
- BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenth decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
Key exclusion criteria (3 listed)
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- History of any clinically significant sensitivity or allergy to any medication or food.
- History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption [e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.].
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NacresertibOral tablet | Drug | Nacresertib |
| Placebo for NacresertibOral tablet | Drug | Placebo for Nacresertib |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of Nacresertib
Time frame: Up to 9 Days
Cmax of Nacresertib
Time to Cmax (Tmax) of Nacresertib
Time frame: Up to 9 Days
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
Time frame: Up to 9 Days
AUCt of Nacresertib
AUC From Time 0 to the Time Infinity (AUCinf) of Nacresertib
Time frame: Up to 9 Days
AUCinf of Nacresertib
Terminal Phase Elimination Rate Constant (Beta) of Nacresertib
Time frame: Up to 9 Days
Beta of Nacresertib
Terminal Phase Elimination Half-Life (t1/2) of Nacresertib
Time frame: Up to 9 Days
t1/2 of Nacresertib
Number of Participants Experiencing Adverse Events (AEs)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteer
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
RecruitingEarly Phase 1
Study Brain Mechanisms of Frustration With Magnetoencephalography in Healthy Volunteers
Irritability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nacresertib in people with Healthy Volunteer, run by AbbVie at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) of Nacresertib (time frame: Up to 9 Days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.