A Study to Evaluate How Multiple Doses of Itraconazole Interacts With Nacresertib in Healthy Adult Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nacresertib, Itraconazole.
- Who it may be relevant to
- Registry conditions: Healthy Volunteer. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug Nacresertib
Oral Tablet - Drug Itraconazole
Oral Capsule
Primary outcome measures
- Maximum Observed Plasma Concentration (Cmax) of Nacresertib [Time frame: Up to Day 12]
- Time to Cmax (Tmax) of Nacresertib [Time frame: 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 [Time frame: Up to Day 12]
- AUC From Time 0 to the Time Infinity (AUCinf) of Nacresertib [Time frame: Up to Day 12]
- Terminal Phase Elimination Rate Constant (Beta) of Nacresertib [Time frame: Up to Day 12]
- Terminal Phase Elimination Half-Life (t1/2) of Nacresertib [Time frame: Up to Day 12]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Acpru /Id# 282339 — Grayslake
Identifiers
NCT: NCT07649954 · M25-472