Healthy ParticipantsPhase 1NCT07800429
Effect of a Known P-glycoprotein (P-gp) Inhibitor, Itraconazole, on the Pharmacokinetics (PK) of Engasertib
A Phase 1 study testing Engasertib and Itraconazole in people with Healthy Participants, run by Vaderis Therapeutics AG at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Engasertib and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteGermany
- Study dates
- 18 Sep 2026to Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age of 18 to 55 years (both inclusive), at the time of signing the informed consent.
- 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.
- 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.
- Overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs, electrocardiogram (ECG).
- Clinically acceptable clinical laboratory test results at screening.
- 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.
- Capable of giving signed informed consent.
- 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.
Who cannot join
- 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.
- Any clinically important illness, medical/surgical procedure, or condition, which, in the opinion of the investigator, is likely to interfere with the study conduct.
- Known or suspected hypersensitivity to engasertib, or itraconazole, or any components of the formulation used.
- History of significant or uncontrolled skin disorders, per the Investigator's judgement.
- 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).
- History or presence of disorders of glucose metabolism.
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- Known or suspected thyroid disorders as evidenced by assessment of thyroid-stimulating hormone (TSH) levels outside the normal reference range at screening.
- Known or suspected liver disorders (e.g., Morbus Gilbert / Meulengracht) and bile secretion/flow (cholestasis, also history of it).
- Difficulty in swallowing.
- History or evidence of malabsorption or any gastrointestinal surgery except appendectomy and herniotomy.
- History of any chronic disease which might interfere with the absorption, distribution, metabolism or excretion of the study drug.
- Lactose intolerance.
- Contraindications for the use of itraconazole.
- Tendency for vasovagal reactions (e.g., after venipuncture) or history of syncope.
- Febrile illness within 1 week before first dosing.
- Diagnosis or history of immunodeficiency or increased susceptibility to severe infection, or a clinically significant infection within 4 weeks prior to screening.
- 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.
- 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.
- Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to screening.
- 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.
- 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.
- Positive screen for alcohol, drugs of abuse and cotinine test at screening.
- 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.
- 12-lead ECG with clinically relevant abnormality.
- 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.
- Estimated glomerular filtration rate (eGFR) according to the Chronic Kidney Disease Epidemiology Collaboration Creatinine Equation (2009) < 90 mL/min at screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label Study to Evaluate the Effect of a Known P-gp Inhibitor, Itraconazole, on the Pharmacokinetics of Engasertib in Healthy Adult Participants
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.
- Conditions
- Healthy Participants
- Being tested
- Engasertib, Itraconazole
- Keywords
- Engasertib, VAD044, P-gp Inhibitor, Itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EngasertibDrug
Also called VAD044
Participants will take engasertib orally as capsules.
ItraconazoleDrug
Participants will take itraconazole as 20 mL of 10 mg/mL oral solution.
| Study group | Role | What they receive |
|---|---|---|
| Engasertib 40 mg + Itraconazole 200 mg | Experimental | 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. Receives: Drug: Engasertib; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-time Curve (AUC) from Zero to the Last Quantifiable Concentration (AUC0-tlast) of Engasertib
Measured: Day 1 up to Day 26
AUC from Zero to Infinity (AUC0-inf) of Engasertib
Measured: Day 1 up to Day 26
Maximum Plasma Concentration (Cmax) of Engasertib
Measured: Day 1 up to Day 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start18 Sep 2026
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vaderis Therapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800429
- Sponsor's protocol ID
- ENG-101
- Other IDs
- 2026-526311-11-00
- Status last verified
- Oct 2026
- First submitted
- 28 Aug 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study to Evaluate the Effect of a Known P-gp Inhibitor, Itraconazole, on the Pharmacokinetics of Engasertib in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07800429
- Acronym / sponsor ID
- ENG-101
- Conditions
- Healthy Participants
- Keywords
- Engasertib, VAD044, P-gp Inhibitor, Itraconazole
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Vaderis Therapeutics AGIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Engasertib 40 mg + Itraconazole 200 mg | Experimental | Drug: Engasertib, Drug: ItraconazoleAll 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age of 18 to 55 years (both inclusive), at the time of signing the informed consent.
- 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.
- 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.
- Overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs, electrocardiogram (ECG).
- Clinically acceptable clinical laboratory test results at screening.
Key exclusion criteria (26 listed)
- 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.
- Any clinically important illness, medical/surgical procedure, or condition, which, in the opinion of the investigator, is likely to interfere with the study conduct.
- Known or suspected hypersensitivity to engasertib, or itraconazole, or any components of the formulation used.
- History of significant or uncontrolled skin disorders, per the Investigator's judgement.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EngasertibAlso: VAD044Participants will take engasertib orally as capsules. | Drug | Engasertib 40 mg + Itraconazole 200 mg |
| ItraconazoleParticipants will take itraconazole as 20 mL of 10 mg/mL oral solution. | Drug | Engasertib 40 mg + Itraconazole 200 mg |
Primary outcome
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
AUC from Zero to Infinity (AUC0-inf) of Engasertib
Time frame: Day 1 up to Day 26
Maximum Plasma Concentration (Cmax) of Engasertib
Time frame: Day 1 up to Day 26
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Engasertib and Itraconazole in people with Healthy Participants, run by Vaderis Therapeutics AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.