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NCT Number: NCT07649954

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

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.

Recruiting

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Acpru /Id# 282339

Grayslake, Illinois, 60030, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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:

  • 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 criteria

  • 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.

Treatment and study plan

nacresertib

Drug

Oral Tablet

Itraconazole

Drug

Oral Capsule

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of Nacresertib

    Time frame: Up to Day 12

    Cmax of Nacresertib

  2. Time to Cmax (Tmax) of Nacresertib

    Time frame: Up to Day 12

    Tmax of Nacresertib

  3. 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

  4. AUC From Time 0 to the Time Infinity (AUCinf) of Nacresertib

    Time frame: Up to Day 12

    AUCinf of Nacresertib

  5. Terminal Phase Elimination Rate Constant (Beta) of Nacresertib

    Time frame: Up to Day 12

    Beta of Nacresertib

  6. Terminal Phase Elimination Half-Life (t1/2) of Nacresertib

    Time frame: Up to Day 12

    t1/2 of Nacresertib

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 16, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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