Healthy ParticipantsPhase 1NCT07783503
A Drug-drug Interaction Study to Assess the Effect of Phenytoin and Itraconazole on the Pharmacokinetics of Pelabresib in Healthy Participants
A Phase 1 study testing Pelabresib, Phenytoin and Itraconazole in people with Healthy Participants, run by Novartis Pharmaceuticals at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess the effect of multiple doses of phenytoin, a strong cytochrome P450 (CYP)3A4 inducer, and itraconazole, a strong CYP3A4 inhibitor, on the pharmacokinetic (PK) profile of DAK539 (hereafter referred to as pelabresib) after a single dose in healthy 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?
- Pelabresib, Phenytoin and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Sep 2026to 15 Nov 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
- Participants willing to adhere to the protocol requirements and to provide written informed consent prior to participation in the study.
- Healthy male and non-childbearing potential female participants between 18 and 55 years of age, inclusive.
- In good health as determined by no clinically significant findings from medical history, physical examination, vital signs, electrocardiograms (ECG) and laboratory tests.
- 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.
- Vital signs after being supine for 5 minutes in a quiet environment must be within the following ranges:
- oral temperature ≤ 37.5°C.
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- systolic blood pressure between 90 and 139 mmHg.
- diastolic blood pressure between 45 and 89 mmHg.
- pulse rate between 50 and 100 bpm.
- Able to read, speak, and understand the local language, to understand and comply with the requirements of the study.
Who cannot join
- History or current diagnosis of ECG or cardiac abnormalities indicating significant risk of safety for participants.
- History of clinically significant cardiovascular, renal, hepatic, testicular, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the Investigator.
- Clinically significant abnormal clinical chemistry, hematology, coagulation, or urinalysis as judged by the Investigator at screening or first baseline (admission).
- 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.
- Any single parameter of amylase or lipase > 1.2 × ULN, or any history or presence of clinical symptoms suggestive of pancreatitis.
- 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.
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- 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.
- Positive hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) 1 and 2 antibody results.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
United Kingdom1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Nottingham, NG11 6JS
About this study
Official title: A Phase 1, Two-part, Open-label, Drug-drug Interaction Study to Assess the Effect of Phenytoin and Itraconazole on the Pharmacokinetics of Pelabresib in Healthy Participants
The purpose of this study is to assess the effect of multiple doses of phenytoin, a strong cytochrome P450 (CYP)3A4 inducer, and itraconazole, a strong CYP3A4 inhibitor, on the pharmacokinetic (PK) profile of DAK539 (hereafter referred to as pelabresib) after a single dose in healthy participants. In addition, the safety and tolerability of a single dose of pelabresib with and without the co-administration of itraconazole or phenytoin will be evaluated.
Read the detailed description
This is a 2-part, open-label, drug-drug interaction (DDI) study to assess the effect of phenytoin (a strong CYP3A4 inducer) and itraconazole (a strong CYP3A4 inhibitor) on the pharmacokinetics of pelabresib in healthy participants.
The study includes two parts, each with two treatment periods. In Part 1, participants will be administered pelabresib in Treatment Period 1 and pelabresib and phenytoin in Treatment Period 2.
In Part 2, participants will be administered pelabresib in Treatment Period 1 and pelabresib and itraconazole in Treatment Period 2.
- Conditions
- Healthy Participants
- Being tested
- Pelabresib, Phenytoin, Itraconazole
- Keywords
- drug-drug interaction study, DDI study, Healthy participants, Pelabresib, DAK539, Phenytoin, Itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PelabresibDrug
Also called DAK539
Oral dosing
PhenytoinDrug
Oral dosing
ItraconazoleDrug
Oral dosing
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Pelabresib + Phenytoin | Experimental | Single dose of pelabresib (Treatment Period 1), followed by a single dose of pelabresib plus repeated doses of phenytoin (Treatment Period 2) Receives: Drug: Pelabresib; Drug: Phenytoin |
| Part 2: Pelabresib + Itraconazole | Experimental | Single dose of pelabresib (Treatment Period 1), followed by a single dose of pelabresib plus repeated doses of itraconazole (Treatment Period 2) Receives: Drug: Pelabresib; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 and 2: Maximum observed plasma concentration (Cmax) of pelabresib
Pharmacokinetic (PK) parameters determined using the actual recorded sampling times and non- compartmental method(s) from the pelabresib plasma concentration-time data.
Measured: From pre-dose up to 48 or 72 hours after pelabresib administration
Part 1 and 2: Area under the plasma concentration-time curve from time 0 to the last measurable concentration sampling time (AUClast) of pelabresib
PK parameters determined using the actual recorded sampling times and non- compartmental method(s) from the pelabresib plasma concentration-time data.
Measured: From pre-dose up to 48 or 72 hours after pelabresib administration
Part 1 and 2: Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of pelabresib
PK parameters determined using the actual recorded sampling times and non- compartmental method(s) from the pelabresib plasma concentration-time data.
Measured: From pre-dose up to 48 or 72 hours after pelabresib administration
Part 1 and 2: Time to reach maximum plasma concentration (Tmax) of pelabresib
PK parameters determined using the actual recorded sampling times and non- compartmental method(s) from the pelabresib plasma concentration-time data.
Measured: From pre-dose up to 48 or 72 hours after pelabresib administration
Secondary outcomes (4)
Part 1 and 2: Apparent plasma clearance (CL/F) of pelabresib
Pharmacokinetic (PK) parameters determined using the actual recorded sampling times and non- compartmental method(s) from the pelabresib plasma concentration-time data.
Measured: From pre-dose up to 48 or 72 hours after pelabresib administration
Part 1 and 2: Apparent volume of distribution during the terminal elimination phase (Vz/F) of pelabresib
Pharmacokinetic (PK) parameters determined using the actual recorded sampling times and non- compartmental method(s) from the pelabresib plasma concentration-time data.
Measured: From pre-dose up to 48 or 72 hours after pelabresib administration
Part 1 and 2: Terminal elimination half-life (T1/2) of pelabresib
Pharmacokinetic (PK) parameters determined using the actual recorded sampling times and non- compartmental method(s) from the pelabresib plasma concentration-time data.
Measured: From pre-dose up to 48 or 72 hours after pelabresib administration
Part 1 and 2: Incidence of adverse events (AEs) and serious adverse events (SAEs)
Number of participants with AEs and SAEs, including changes in vital signs, electrocardiograms and laboratory values qualifying and reported as AEs.
Measured: Up to approximately 30 days after the last dose of study drug (Day 48 in Part 1 and Day 40 in Part 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start2 Sep 2026
- Primary completion13 Nov 2026 (estimated)
- Study completion15 Nov 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.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783503
- Sponsor's protocol ID
- CDAK539A12101
- Status last verified
- Sep 2026
- First submitted
- 18 Aug 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Two-part, Open-label, Drug-drug Interaction Study to Assess the Effect of Phenytoin and Itraconazole on the Pharmacokinetics of Pelabresib in Healthy Participants
- ClinicalTrials.gov ID
- NCT07783503
- Acronym / sponsor ID
- CDAK539A12101
- Conditions
- Healthy Participants
- Keywords
- drug-drug interaction study, DDI study, Healthy participants, Pelabresib, DAK539, Phenytoin, Itraconazole
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2026 (actual)
- Primary completion
- 13 Nov 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 24 Aug 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 purpose of this study is to assess the effect of multiple doses of phenytoin, a strong cytochrome P450 (CYP)3A4 inducer, and itraconazole, a strong CYP3A4 inhibitor, on the pharmacokinetic (PK) profile of DAK539 (hereafter referred to as pelabresib) after a single dose in healthy participants. In addition, the safety and tolerability of a single dose of pelabresib with and without the co-administration of itraconazole or phenytoin will be evaluated.
Detailed description
This is a 2-part, open-label, drug-drug interaction (DDI) study to assess the effect of phenytoin (a strong CYP3A4 inducer) and itraconazole (a strong CYP3A4 inhibitor) on the pharmacokinetics of pelabresib in healthy participants.
The study includes two parts, each with two treatment periods. In Part 1, participants will be administered pelabresib in Treatment Period 1 and pelabresib and phenytoin in Treatment Period 2.
In Part 2, participants will be administered pelabresib in Treatment Period 1 and pelabresib and itraconazole in Treatment Period 2.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Pelabresib + Phenytoin | Experimental | Drug: Pelabresib, Drug: PhenytoinSingle dose of pelabresib (Treatment Period 1), followed by a single dose of pelabresib plus repeated doses of phenytoin (Treatment Period 2) |
| Part 2: Pelabresib + Itraconazole | Experimental | Drug: Pelabresib, Drug: ItraconazoleSingle dose of pelabresib (Treatment Period 1), followed by a single dose of pelabresib plus repeated doses of itraconazole (Treatment Period 2) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Participants willing to adhere to the protocol requirements and to provide written informed consent prior to participation in the study.
- Healthy male and non-childbearing potential female participants between 18 and 55 years of age, inclusive.
- In good health as determined by no clinically significant findings from medical history, physical examination, vital signs, electrocardiograms (ECG) and laboratory tests.
- 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.
- Vital signs after being supine for 5 minutes in a quiet environment must be within the following ranges:
Key exclusion criteria (11 listed)
- History or current diagnosis of ECG or cardiac abnormalities indicating significant risk of safety for participants.
- History of clinically significant cardiovascular, renal, hepatic, testicular, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the Investigator.
- Clinically significant abnormal clinical chemistry, hematology, coagulation, or urinalysis as judged by the Investigator at screening or first baseline (admission).
- 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.
- Any single parameter of amylase or lipase > 1.2 × ULN, or any history or presence of clinical symptoms suggestive of pancreatitis.
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 |
|---|---|---|
| PelabresibAlso: DAK539Oral dosing | Drug | Part 1: Pelabresib + Phenytoin, Part 2: Pelabresib + Itraconazole |
| PhenytoinOral dosing | Drug | Part 1: Pelabresib + Phenytoin |
| ItraconazoleOral dosing | Drug | Part 2: Pelabresib + Itraconazole |
Primary outcome
Part 1 and 2: Maximum observed plasma concentration (Cmax) of pelabresib
Time frame: From pre-dose up to 48 or 72 hours after pelabresib administration
Pharmacokinetic (PK) parameters determined using the actual recorded sampling times and non- compartmental method(s) from the pelabresib plasma concentration-time data.
Part 1 and 2: Area under the plasma concentration-time curve from time 0 to the last measurable concentration sampling time (AUClast) of pelabresib
Time frame: From pre-dose up to 48 or 72 hours after pelabresib administration
PK parameters determined using the actual recorded sampling times and non- compartmental method(s) from the pelabresib plasma concentration-time data.
Part 1 and 2: Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of pelabresib
Time frame: From pre-dose up to 48 or 72 hours after pelabresib administration
PK parameters determined using the actual recorded sampling times and non- compartmental method(s) from the pelabresib plasma concentration-time data.
Part 1 and 2: Time to reach maximum plasma concentration (Tmax) of pelabresib
Time frame: From pre-dose up to 48 or 72 hours after pelabresib administration
PK parameters determined using the actual recorded sampling times and non- compartmental method(s) from the pelabresib plasma concentration-time data.
4 secondary outcomes
Part 1 and 2: Apparent plasma clearance (CL/F) of pelabresib
Time frame: From pre-dose up to 48 or 72 hours after pelabresib administration
Part 1 and 2: Apparent volume of distribution during the terminal elimination phase (Vz/F) of pelabresib
Time frame: From pre-dose up to 48 or 72 hours after pelabresib administration
Part 1 and 2: Terminal elimination half-life (T1/2) of pelabresib
Time frame: From pre-dose up to 48 or 72 hours after pelabresib administration
Part 1 and 2: Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to approximately 30 days after the last dose of study drug (Day 48 in Part 1 and Day 40 in Part 2)
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 22 Sep 2026.
- Individual participant dataSharing planned: No. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.
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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.
Novartis Pharmaceuticals contact
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 Pelabresib, Phenytoin and Itraconazole in people with Healthy Participants, run by Novartis Pharmaceuticals at 1 site in United Kingdom.
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 10 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 22 Sep 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 United Kingdom. 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?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1 and 2: Maximum observed plasma concentration (Cmax) of pelabresib (time frame: From pre-dose up to 48 or 72 hours after pelabresib administration). The study lists 4 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 22 Sep 2026.