Back to search results

Study on Itraconazole and Nacresertib Interaction in Healthy Adults

This study is looking for healthy adult volunteers to understand how two medications, Itraconazole (an oral capsule) and Nacresertib (an oral tablet), interact with each other. The main goal is to see how Itraconazole affects the levels of Nacresertib in your body and to check for any safety concerns when taken together. Researchers will measure the highest level of Nacresertib in your blood, how long it takes to reach that level, and the overall amount of Nacresertib in your system over about 12 days. This study is currently recruiting a small group of 12 participants, aged 18 to 65, with a Body Mass Index (BMI) between 18.0 and 32.0.

Study design
This is an interventional study involving 12 healthy adult participants. The phase of the study is not specified.
What's involved
You will attend regular visits at a hospital or clinic, which could be weekly or monthly. These visits will include medical assessments, blood tests, checking for side effects, and completing questionnaires.
Compensation
Not stated in the trial record.
Follow-up
The main measurements for drug levels will be taken for up to 12 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07649954

A Study to Evaluate How Multiple Doses of Itraconazole Interacts With Nacresertib in Healthy Adult Participants

Recruiting
PHASE1Ages 18–65InterventionalBasic science
AbbVie
~12 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:NacresertibItraconazole

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Observed Plasma Concentration (Cmax) of Nacresertib
Measured over Up to Day 12
+5 more outcomes measured

Conditions

Healthy Volunteer

Explore related trials

Healthy Volunteer

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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.
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.

Exclusion

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.

What this trial measures

  • Maximum Observed Plasma Concentration (Cmax) of NacresertibUp to Day 12

    Cmax of Nacresertib

  • Time to Cmax (Tmax) of NacresertibUp 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 NacresertibUp to Day 12

    AUCt of Nacresertib

  • AUC From Time 0 to the Time Infinity (AUCinf) of NacresertibUp to Day 12

    AUCinf of Nacresertib

  • Terminal Phase Elimination Rate Constant (Beta) of NacresertibUp to Day 12

    Beta of Nacresertib

  • Terminal Phase Elimination Half-Life (t1/2) of NacresertibUp to Day 12

    t1/2 of Nacresertib