Can a common fungal drug change how a new cancer drug acts?

NCT ID NCT07800429

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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As listed by the trial registrant

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