ClinicalTrials.gg
CompletedNCT07800429Updated Nov 9, 2026

Effect of a Known P-glycoprotein (P-gp) Inhibitor, Itraconazole, on the Pharmacokinetics (PK) of Engasertib

A Phase 1 interventional study of Engasertib and Itraconazole in Healthy Participants, sponsored by Vaderis Therapeutics AG. Completed at 1 site in Germany. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Vaderis Therapeutics AG · Phase 1, Interventional, and Basic science

Updated Nov 9, 2026Now CompletedNow Active, not recruiting+4 moreGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
27
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The primary objective of this trial is to assess the effect of a known P-gp inhibitor, itraconazole, on the PK of engasertib in healthy adult participants.

02

Conditions studied

  • Healthy Participants

Keywords

  • Engasertib
  • VAD044
  • P-gp Inhibitor
  • Itraconazole
03

In context

Lead sponsor

Vaderis Therapeutics AG is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age of 18 to 55 years (both inclusive), at the time of signing the .
  2. Body weight ≥ 50 and \< 120 kg and a (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 /barrier as detailed in the protocol.
  4. Overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs, (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

Exclusion Criteria:

  1. Any history or evidence of any cardiovascular, hepatic, renal, gastrointestinal, pancreatic, endocrinologic, hematologic, immunologic, metabolic, and/or other major disease or 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 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. 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 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 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 virus (HBV) panel test (Hepatitis B virus surface antigen [HBsAg], Hepatitis B Core Antibody [HBcAb], Hepatitis B surface antibody [HBsAb]), virus (HCV) (RNA), (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 with clinically relevant abnormality.
  25. Elevations in (ALT) > 1.1 x , aspartate aminotransferase (AST) > 1.2 x ULN, serum > 1.2 x ULN, creatinine ≥ 1.1 x ULN at screening.
  26. Estimated (eGFR) according to the Chronic Kidney Disease Epidemiology Collaboration Creatinine Equation (2009) \< 90 mL/min at screening.
Terms in these criteria, in plain language(16)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    Engasertib 40 mg + Itraconazole 200 mg

    All participants will take a single oral dose of engasertib 40 mg on Day 1. Participants will then take itraconazole 200 mg orally once daily (QD) from Day 12 to Day 24. On Day 15, a single oral dose of engasertib 40 mg will be administered 1 hour after the itraconazole dose.

    Drug: Engasertib · Drug: Itraconazole

Interventions

  • Participants will take engasertib orally as capsules.

    Also known as: VAD044

  • DrugItraconazole

    Participants will take itraconazole as 20 mL of 10 mg/mL oral solution.

06

What researchers measure

Primary outcomes

  1. Area Under the Concentration-time Curve (AUC) from Zero to the Last Quantifiable Concentration (AUC0-tlast) of Engasertib

    Time frame: Day 1 up to Day 26

  2. AUC from Zero to Infinity (AUC0-inf) of Engasertib

    Time frame: Day 1 up to Day 26

  3. Maximum Plasma Concentration (Cmax) of Engasertib

    Time frame: Day 1 up to Day 26

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2026 to primary completion in Oct 2026, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 28, 2026
First posted
Sep 2, 2026
StartActual
Sep 18, 2026
Primary completionActual
Oct 28, 2026
CompletionActual
Oct 28, 2026
Last update
Nov 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Active, not recruiting→Completed
changed Oct 15, 2026 · changed Nov 9, 2026
Sites
2 sites added, 1 site removed — first site in Germany
Show 2 added (2 Germany)
  • Nuvisan GmbH · Neu-Ulm, Germany
  • Nuvisan GmbH · Neu-Ulm, Germany
Show 1 removed
  • Nuvisan GmbH · Neu-Ulm, Germany
across 2 updates, Oct 15, 2026 – Nov 9, 2026
Show all 2 updates
  1. Nov 9, 2026
    Active, not recruiting→Completed
    1 site added, 1 site removed
    Show site
    • Nuvisan GmbH · Neu-Ulm, Germany
    Show 1 removed
    • Nuvisan GmbH · Neu-Ulm, Germany
    + 2 other changes: verification date and date precision
  2. Oct 15, 2026
    Not yet recruiting→Active, not recruiting
    1 site added — first site in Germany
    Show site
    • Nuvisan GmbH · Neu-Ulm, Germany
    + 3 other changes: verification date, date precision and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07800429
Lead sponsor
Vaderis Therapeutics AG
Responsible party
Sponsor
First posted
Sep 2, 2026
Start date
Sep 18, 2026
Primary completion
Oct 28, 2026
Completion
Oct 28, 2026
Last update
Nov 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Engasertib

Start the discussion