Can common drugs change how a cancer therapy works?

NCT ID NCT07783503

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This Phase 1 trial is testing whether two common medications—phenytoin, a seizure drug, and itraconazole, an antifungal—change how the body processes pelabresib, an experimental cancer drug. Healthy adults aged 18 to 55 will receive a single dose of pelabresib alone and then again with either phenytoin or itraconazole. The study measures drug levels in the blood to see if these interactions affect how much pelabresib stays in the body and how it is cleared. The goal is to understand potential dosing adjustments needed when pelabresib is used with other drugs.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pelabresib (also called DAK539), given alone or with phenytoin or itraconazole
What this could lead to
If successful, this study could help determine the right dosing of pelabresib when taken with other medications, potentially improving its safety and effectiveness in future cancer treatments.
What could go wrong
This is an early-phase study in healthy volunteers, not patients, so results may not predict effects in people with cancer. The drug interactions could also alter pelabresib levels in unexpected ways, requiring dose adjustments.

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 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Nov 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. Participants willing to adhere to the protocol requirements and to provide written informed consent prior to participation in the study. 2. Healthy male and non-childbearing potential female participants between 18 and 55 years of age, inclusive. 3. In good health as determined by no clinically significant findings from medical history, physical examination, vital signs, electrocardiograms (ECG) and laboratory tests. 4. Body Mass Index (BMI) within the range of 18.5 to 29.9 kg/m2, inclusive, with body weight at least 50.0 kg at screening. 5. Vital signs after being supine for 5 minutes in a quiet environment must be within the following ranges: * oral temperature ≤ 37.5°C. * systolic blood pressure between 90 and 139 mmHg. * diastolic blood pressure between 45 and 89 mmHg. * pulse rate between 50 and 100 bpm. 6. Able to read, speak, and understand the local language, to understand and comply with the requirements of the study. Exclusion Criteria: 1. History or current diagnosis of ECG or cardiac abnormalities indicating significant risk of safety for participants. 2. History of clinically significant cardiovascular, renal, hepatic, testicular, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the Investigator. 3. Clinically significant abnormal clinical chemistry, hematology, coagulation, or urinalysis as judged by the Investigator at screening or first baseline (admission). 4. Evidence of renal impairment as indicated by creatinine or blood urea level \> 1.0 × upper limit of normal (ULN) or clinically significant microalbuminuria or hematuria or clinically significant elevated cystatin-C at screening; evidence of urinary obstruction, or difficulty in voiding at screening; evidence of congenital renal abnormalities with known effect on renal function; calculated estimated glomerular filtration rate (eGFR) \< 80 mL/min using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula for adults at Screening. 5. Any single parameter of amylase or lipase \> 1.2 × ULN, or any history or presence of clinical symptoms suggestive of pancreatitis. 6. History of malignancy in any organ system (excluding localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of evidence of local recurrence or metastases. 7. Participants who have received other investigational drugs within 5 half-lives or within 90 days or until the expected pharmacodynamic effect has returned to baseline prior to first dose of study treatment, whichever is longer. 8. Positive hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) 1 and 2 antibody results. 9. Any surgical or medical condition (impaired GI function, inflammatory bowel disease, peptic ulcers, GI bleeding including rectal bleeding, GI surgeries such as gastrectomy, cholecystectomy, gastroenterostomy, or bowel resection) which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs, or which may jeopardize the participant in case of participation in the study. 10. History of malignancy in any organ system (excluding localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of evidence of local recurrence or metastases. Other protocol-defined inclusion/exclusion criteria may apply.

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