NCT07649954 A Study to Evaluate How Multiple Doses of Itraconazole Interacts With Nacresertib in Healthy Adult Participants
| NCT ID | NCT07649954 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | AbbVie |
| Condition | Healthy Volunteer |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2026-06-23 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2026-06-23 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
ABBVIE INC.
STUDY DIRECTOR
AbbVie
Frequently Asked Questions
Who can join the NCT07649954 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Healthy Volunteer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07649954 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07649954 currently recruiting?
Yes, NCT07649954 is actively recruiting participants. Contact the research team at abbvieclinicaltrials@abbvie.com for enrollment information.
Where is the NCT07649954 trial being conducted?
This trial is being conducted at Grayslake, United States.
Who is sponsoring the NCT07649954 clinical trial?
NCT07649954 is sponsored by AbbVie. The principal investigator is ABBVIE INC. at AbbVie. The trial plans to enroll 12 participants.