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

NCT07649954 | Recruiting Phase 1 FDA Drug

• 1 other identifier: M25-472
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Healthy Volunteer

Outcome Measures

Primary Outcomes (6)

• Maximum Observed Plasma Concentration (Cmax) of Nacresertib

  Cmax of Nacresertib

  Up to Day 12

• Time to Cmax (Tmax) of Nacresertib

  Tmax of Nacresertib

  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

  Up to Day 12

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

  AUCinf of Nacresertib

  Up to Day 12

• Terminal Phase Elimination Rate Constant (Beta) of Nacresertib

  Beta of Nacresertib

  Up to Day 12

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

  t1/2 of Nacresertib

  Up to Day 12

Study Arms (2)

Period 1: Nacresertib Only

EXPERIMENTAL

Participant receives single dose of Nacresertib administered on Day 1

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.

Drug: Nacresertib; Drug: Itraconazole

Interventions

Nacresertib DRUG

Oral Tablet

Period 1: Nacresertib Only; Period 2: Nacresertib and Itraconazole

Itraconazole DRUG

Oral Capsule

Period 2: Nacresertib and Itraconazole

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Acpru /Id# 282339

Grayslake, Illinois, 60030, United States

RECRUITING

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 16, 2026
• Study Start: June 23, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)