Healthy VolunteerPhase 1NCT07649954
A Study to Evaluate How Multiple Doses of Itraconazole Interacts With Nacresertib in Healthy Adult Participants
A Phase 1 study testing Nacresertib and Itraconazole in people with Healthy Volunteer, run by AbbVie at 1 site in United States.
Trial summary
This study will evaluate how multiple doses of Itraconazole Impacts the performance of Nacresertib in healthy adult participants The goal of this study is to assess the safety and drug to drug interaction between Itraconazole and Nacresertib. 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 and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2026to Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- 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 rounding to the tenths decimal at screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG.
- Female participants meet the following criteria.
- Non-Childbearing Potential due to meeting at least one of the following criteria:
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- Permanent sterility due to a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.
- Non-surgical permanent infertility due to Mullerian agenesis, androgen insensitivity, or gonadal dysgenesis; investigator discretion should be applied to determining study entry.
- Postmenopausal female who is age ≤ 55 years with no menses for 12 or more months without an alternative medical cause AND a follicle-stimulating hormone (FSH) level ≥ 30 IU/L.
- Postmenopausal female who is age > 55 years with no menses for 12 or more months without an alternative medical cause.
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.
- Participant has any clinically significant ECG abnormalities including the following:
- Evidence of 2nd or 3rd degree atrioventricular (AV) block at screening visit or upon initial confinement
- QT interval corrected for heart rate (QTc) using Fridericia's correction formula (QTcF) ˃ 450 msec (males) or ˃ 460 msec (females) at screening visit or upon initial confinement.
- 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.].
- Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma, or localized carcinoma in situ of the cervix.
- History or evidence of active tuberculosis (TB) disease or latent TB infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Open-Label, Two-Period Study to Evaluate the Impact of Multiple Doses of Itraconazole on the Pharmacokinetics of Nacresertib in Healthy Adult Subjects
This study will evaluate how multiple doses of Itraconazole Impacts the performance of Nacresertib in healthy adult participants
The goal of this study is to assess the safety and drug to drug interaction between Itraconazole and Nacresertib.
There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
- Conditions
- Healthy Volunteer
- Being tested
- Nacresertib, Itraconazole
- 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
ItraconazoleDrug
Oral Capsule
| Study group | Role | What they receive |
|---|---|---|
| Period 1: Nacresertib Only | Experimental | Participant receives single dose of Nacresertib administered on Day 1 Receives: Drug: Nacresertib |
| Period 2: Nacresertib and Itraconazole | Experimental | Participant 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. Receives: Drug: Nacresertib; Drug: Itraconazole |
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 Day 12
Time to Cmax (Tmax) of Nacresertib
Tmax of Nacresertib
Measured: Up to Day 12
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 Day 12
AUC From Time 0 to the Time Infinity (AUCinf) of Nacresertib
AUCinf of Nacresertib
Measured: Up to Day 12
Terminal Phase Elimination Rate Constant (Beta) of Nacresertib
Beta of Nacresertib
Measured: Up to Day 12
Terminal Phase Elimination Half-Life (t1/2) of Nacresertib
t1/2 of Nacresertib
Measured: Up to Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start23 Jun 2026
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- 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
- NCT07649954
- Sponsor's protocol ID
- M25-472
- Status last verified
- Sep 2026
- First submitted
- 11 Jun 2026
- Last updated
- 18 Sep 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 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-Label, Two-Period Study to Evaluate the Impact of Multiple Doses of Itraconazole on the Pharmacokinetics of Nacresertib in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT07649954
- Acronym / sponsor ID
- M25-472
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 16 Jun 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.
This study will evaluate how multiple doses of Itraconazole Impacts the performance of Nacresertib in healthy adult participants
The goal of this study is to assess the safety and drug to drug interaction between Itraconazole and Nacresertib.
There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period 1: Nacresertib Only | Experimental | Drug: NacresertibParticipant receives single dose of Nacresertib administered on Day 1 |
| Period 2: Nacresertib and Itraconazole | Experimental | Drug: Nacresertib, Drug: ItraconazoleParticipant 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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 rounding to the tenths decimal at screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG.
- Female participants meet the following criteria.
Key exclusion criteria (8 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.
- Participant has any clinically significant ECG abnormalities including the following:
- 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.].
- Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma, or localized carcinoma in situ of the cervix.
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 | Period 1: Nacresertib Only, Period 2: Nacresertib and Itraconazole |
| ItraconazoleOral Capsule | Drug | Period 2: Nacresertib and Itraconazole |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of Nacresertib
Time frame: Up to Day 12
Cmax of Nacresertib
Time to Cmax (Tmax) of Nacresertib
Time frame: 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
Time frame: Up to Day 12
AUCt of Nacresertib
AUC From Time 0 to the Time Infinity (AUCinf) of Nacresertib
Time frame: Up to Day 12
AUCinf of Nacresertib
Terminal Phase Elimination Rate Constant (Beta) of Nacresertib
Time frame: Up to Day 12
Beta of Nacresertib
Terminal Phase Elimination Half-Life (t1/2) of Nacresertib
Time frame: Up to Day 12
t1/2 of Nacresertib
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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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 and Itraconazole 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 10 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 18 Sep 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. 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?
This study is still under way. Results are not available in the source record yet.
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 Day 12). The study lists 6 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 18 Sep 2026.