Can a common fungal drug change how a new cancer drug acts?
NCT ID NCT07800429
First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time
Summary
Researchers are testing whether itraconazole, a known drug that blocks certain liver enzymes, changes how the body processes engasertib, an experimental drug. Healthy adults aged 18 to 55 will take engasertib alone and then with itraconazole. The study measures engasertib levels in the blood to see if the combination alters its absorption or breakdown. This information helps guide safe dosing for future trials.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Engasertib (also called VAD044), taken as oral capsules, with itraconazole as an oral solution
- What this could lead to
- If it works, this could help researchers set the right dose of engasertib for future studies in people with disease.
- What could go wrong
- This is an early, small trial in healthy volunteers, not patients. It only measures drug levels, not whether engasertib works for any condition.
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
-
About 27 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Sep 2026
An estimate. Start dates often move.
- Expected to finish
-
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 55 years
- Sex
-
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: 1. Age of 18 to 55 years (both inclusive), at the time of signing the informed consent. 2. Body weight ≥ 50 and \< 120 kg and a body mass index (BMI) within the range 18 to 30 kg/m\^2 (both inclusive) at screening. 3. Male and female participants are eligible to participate if they are not fertile or if they agree to either be abstinent from intercourse where pregnancy can occur or use contraception/barrier as detailed in the protocol. 4. Overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs, electrocardiogram (ECG). 5. Clinically acceptable clinical laboratory test results at screening. 6. Non-smoker, former smoker or stable non-smoker (= 0 cigarettes, pipes, cigars, or others) for at least 3 months prior to screening. Participants must also have abstained from use of other nicotine containing products (e.g., nicotine patch, chewing gum or e-cigarettes) for at least 3 months before screening. 7. Capable of giving signed informed consent. 8. Re-admission: overtly healthy as determined by medical evaluation including check of changes in medical history compared to screening, clinical laboratory test results, abbreviated physical examination, vital signs, and ECG. Exclusion Criteria: 1. Any history or evidence of any clinically relevant cardiovascular, hepatic, renal, gastrointestinal, pancreatic, endocrinologic, hematologic, immunologic, metabolic, and/or other major disease or malignancy as determined by medical evaluation (including physical examination) capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data. 2. Any clinically important illness, medical/surgical procedure, or condition, which, in the opinion of the investigator, is likely to interfere with the study conduct. 3. Known or suspected hypersensitivity to engasertib, or itraconazole, or any components of the formulation used. 4. History of significant or uncontrolled skin disorders, per the Investigator's judgement. 5. Any clinically significant history of allergic conditions (including allergies to more than 3 allergens, drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). 6. History or presence of disorders of glucose metabolism. 7. Known or suspected thyroid disorders as evidenced by assessment of thyroid-stimulating hormone (TSH) levels outside the normal reference range at screening. 8. Known or suspected liver disorders (e.g., Morbus Gilbert / Meulengracht) and bile secretion/flow (cholestasis, also history of it). 9. Difficulty in swallowing. 10. History or evidence of malabsorption or any gastrointestinal surgery except appendectomy and herniotomy. 11. History of any chronic disease which might interfere with the absorption, distribution, metabolism or excretion of the study drug. 12. Lactose intolerance. 13. Contraindications for the use of itraconazole. 14. Tendency for vasovagal reactions (e.g., after venipuncture) or history of syncope. 15. Febrile illness within 1 week before first dosing. 16. Diagnosis or history of immunodeficiency or increased susceptibility to severe infection, or a clinically significant infection within 4 weeks prior to screening. 17. Use of any concomitant medication or any drugs / medicines (including dietary supplements, natural and herbal remedies, and hormone replacement therapy) within 2 weeks or 5 times the half-life of the respective drug, whichever is longer, prior to screening. Occasional use of paracetamol (2 grams/day; medicinal products in their original packaging, approved and marketed in Germany) is permitted. Oral, injectable, implantable, and topical contraceptives are permitted. 18. Administration of live, attenuated, replication-competent vaccine(s) and vector-based or mRNA COVID-19 vaccine(s) within 1 month prior to screening or plans to receive such vaccines during the study. 19. Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to screening. 20. Use of any investigational drug or participation in any clinical study within 30 days or 5 half-life times of study intervention administered in a previous trial, whichever is longer, prior to the expected date of first administration of study intervention or planning to take other investigational drugs during the study. 21. Positive for hepatitis B virus (HBV) panel test (Hepatitis B virus surface antigen \[HBsAg\], Hepatitis B Core Antibody \[HBcAb\], Hepatitis B surface antibody \[HBsAb\]), hepatitis C virus (HCV) (RNA), human immunodeficiency virus (HIV) 1+2 antibodies and HIV-1 p24 antigen combined at screening. 22. Positive screen for alcohol, drugs of abuse and cotinine test at screening. 23. Supine systolic blood pressure \> 140 mmHg or \< 90 mmHg; diastolic blood pressure \> 90 mmHg or \< 50 mmHg and pulse rate \< 50 bpm or \> 90 bpm (measurements taken after participant has been resting in supine position for 5 min), and tympanic body temperature of \< 35.9 and \> 37.6°C at screening. 24. 12-lead ECG with clinically relevant abnormality. 25. Elevations in alanine transaminase (ALT) \> 1.1 x ULN, aspartate aminotransferase (AST) \> 1.2 x ULN, serum bilirubin \> 1.2 x ULN, creatinine ≥ 1.1 x ULN at screening. 26. Estimated glomerular filtration rate (eGFR) according to the Chronic Kidney Disease Epidemiology Collaboration Creatinine Equation (2009) \< 90 mL/min at screening.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Healthy participants are added.
By submitting, you agree to our Terms of use
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
By submitting, you agree to our Terms of use
Study contacts
-
Contact
Email: •••••@•••••
-
Contact
Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Will a cheaper blood thinner work the same as xarelto?
- Can a CBD and THC mix pave the way for a new migraine therapy?
- Can a pill tame obesity? new oral drug heads to early human tests
- Can a copycat drug match Dupixent's effects?
- Snack bars as a secret weapon against hunger?
- Can common drugs change how a cancer therapy works?