Antifungal drug may alter levels of experimental cancer pill
NCT ID NCT07649954
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 3 times
Summary
This study tests whether taking the antifungal drug itraconazole changes how the body processes nacresertib, an experimental cancer medication. Healthy adults aged 18 to 65 will receive nacresertib alone and then again with itraconazole to compare drug levels in the blood. The goal is to understand potential drug interactions and ensure safety before testing nacresertib in patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Nacresertib and Itraconazole
- What this could lead to
- If successful, this study could help determine safe dosing of nacresertib when taken with common antifungal medications.
- What could go wrong
- This is a very early, small study in healthy volunteers, not patients. Results may not predict effects in people with cancer or other illnesses.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
12 people
The number who actually took part.
- Started
-
Jun 2026
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Acpru /Id# 282339
Grayslake, Illinois, 60030, United States
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