Healthy ParticipantsPhase 1NCT06909162
A Study to Evaluate the Effect of Food on the Single-Dose Pharmacokinetics and a Drug-Drug Interaction Evaluation of Itraconazole and Carbamazepine on INCB123667 When Administered Orally to Healthy Adult Participants
A Phase 1 study testing INCB123667, itraconazole and carbamazepine in people with Healthy Participants, run by Incyte Corporation at 1 site in United States.
Trial summary
This study will be conducted to evaluate the effect of food on the single-dose pharmacokinetics and a drug-drug interaction evaluation of itraconazole and carbamazepine on INCB123667 when administered orally to healthy adult participants. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- INCB123667, itraconazole and carbamazepine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2025to 17 May 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability to comprehend and willingness to sign a written ICF for the study.
- Age 19 (in compliance with Nebraska state law) to 55 years, inclusive, at the time of signing the ICF.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive, at screening. Note: Only up to 25% of the participants may be enrolled with a BMI > 30 to ≤ 32.0 kg/m2.
- No clinically significant findings on screening evaluations (clinical, laboratory results [with the exception of lipids], and ECGs).
- Ability to swallow and retain oral tablets.
- Willingness to avoid pregnancy or fathering children based on the criteria below:
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- Male participants with reproductive potential must agree to take appropriate precautions to avoid fathering children from screening through 180 days after the last dose of study drug and must refrain from donating sperm during this period. Permitted methods in preventing pregnancy should be communicated to the participants and their understanding confirmed.
- Female participants must have a negative serum pregnancy test at screening and a negative urine pregnancy (Cohort 1) and negative serum pregnancy test (Cohorts 2 and 3) at check-in on Day -1 and must agree to take appropriate precautions to avoid pregnancy from screening through 180 days after the last dose of study drug and must refrain from donating oocytes during this period. Permitted methods in preventing pregnancy should be communicated to the participants and their understanding confirmed.
- Female participants not considered to be of childbearing potential as defined in the protocol are eligible.
Who cannot join
- History of uncontrolled or unstable cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening.
- History of an autoimmune disease diagnosis (i.e., myasthenia gravis).
- History of cardiovascular, cerebrovascular, peripheral vascular, or thrombotic disease or uncontrolled hypertension (systolic blood pressure > 140 mm Hg or diastolic blood pressure > 90 mm Hg at screening, confirmed by repeat testing).
- History or presence of an abnormal ECG before initial dose administration that, in the investigator's opinion, is clinically significant. Participants with a QTcF interval > 470 milliseconds (females) and > 450 milliseconds (males), QRS interval > 120 milliseconds, or PR interval > 220 milliseconds will be excluded. In the event a value is exclusionary, a single ECG will be repeated twice, and an average taken of the 3 readings will be used to determine if a participant should be excluded.
- Presence or history of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn's disease or chronic pancreatitis).
- History of malignancy within 5 years of screening, with the exception of cured basal cell or squamous cell carcinoma of the skin, ductal carcinoma in situ, or Gleason 6 prostate cancer.
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- Current or recent (within 3 months of screening) clinically significant gastrointestinal disease or surgery (including cholecystectomy; excluding appendectomy and hernia repair) that could affect the absorption of study drug.
- Confirmed resting pulse rate (up to 2 consecutive measurements) < 40 bpm or > 100 bpm at screening.
- Hemoglobin (11.1-15.9 g/dL), WBC (3.4-10.8 / μL), platelet count, or absolute neutrophil count (1.4-7.0 / μL) less than the laboratory LLN at screening or at check-in, confirmed by repeat testing. White blood cell, hemoglobin, neutrophil, and platelet abnormalities must also be clinically significant in the opinion of the investigator to be exclusionary.
- Hepatic transaminases (ALT and AST), ALP, or total bilirubin > 1.25 × the laboratory-defined ULN at screening or at each check-in, confirmed by repeat testing (except participants with Gilbert's disease, for whom total bilirubin must be ≤ 2.0 × ULN).
- Estimated glomerular filtration rate < 90 mL/min / 1.73 m2 based on the site's standard formula at screening (eGFR [mL/min] = eGFR [mL/min / 1.73m2] × [body surface area / 1.73]).
- NOTE: Assessment of eGFR may be repeated once if outside of the reference range.
- Any major surgery within 4 weeks of screening.
- Donation of blood to a blood bank or participation in a clinical study (except a screening visit) within 4 weeks of screening (within 2 weeks for donation of plasma only).
- Blood transfusion within 4 months of check-in (Day -1).
- Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment (includes latent treated tuberculosis).
- Known tuberculosis infection that is active or participant-reported history of tuberculosis or treatment thereof.
- Positive test result for HBV, HCV, or HIV. Participants whose results are compatible with prior immunization for or immunity due to infection with HBV may be included at the discretion of the investigator.
- Receipt of live (including attenuated) vaccines or anticipation of need for such a vaccine during the study.
- Note: No vaccines of any type may be administered within 3 months prior to the first dose of study treatment.
- Medical or self-reported history of alcoholism within 3 years of screening.
- History of significant alcohol use within 3 months of screening, defined as regular alcohol consumption > 21 units per week for males and > 14 units for females (1 unit = 0.5 pint beer or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type).
- Positive urine or breath test result for ethanol or positive urine or serum screen for drugs of abuse that are not otherwise explained by permitted concomitant medications or diet.
- Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug with another investigational medication or current enrollment in another investigational drug study.
- Current treatment or treatment within 15 days or 5 half-lives (whichever is longer) before the first dose of study drug with an inducer or inhibitor of CYP3A4, P-gp, or breast cancer resistance protein (refer to the Certara Drug Interaction Database Program for prohibited drugs [Certara Drug Interaction Solutions]).
- Consumption of Seville oranges, grapefruit or grapefruit juice, pomelos, exotic citrus fruits, grapefruit hybrids, or fruit juices within 72 hours before the first dose of study drug.
- Current use of prohibited medication as described in the protocol.
- History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator.
- Known hypersensitivity or severe reaction to INCB123667 or any excipients of INCB123667 or any CDK2 inhibitors.
- Inability to undergo venipuncture or tolerate venous access. Participant has inadequate veins for repeat venipuncture or venous access as determined by the investigator.
- Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations, in the opinion of the investigator.
- History of tobacco or nicotine-containing product use within 1 month of screening.
- Use of prescription drugs (including hormonal contraceptives) within 14 days of study drug administration or nonprescription medications/products (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days of study drug administration. However, occasional and standard-dose acetaminophen, ibuprofen, and standard-dose vitamins are permitted. Mega dose vitamins or supplements are not permissible.
- Women who are pregnant or breastfeeding.
- Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
- Excessive exercise (eg, Ironman, bi/triathlon) within the last 3 months.
- Vitamin B12, folate, TSH, or parathyroid hormone levels less than the laboratory LLN at screening that are clinically significant in the opinion of the investigator.
- Participants with laboratory values outside the normal range at screening as (see protocol for required laboratory analytes). Participants with out-of-range values will be assessed by the investigator or designee for eligibility.
- Participants in Cohort 3 (carbamazepine) who test positive for the HLA-B*1502 or HLA-A*3101 alleles during screening will be excluded due to the increased risk SJS/TEN.
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 Food on the Single-Dose Pharmacokinetics and a Drug-Drug Interaction Evaluation of Itraconazole and Carbamazepine on INCB123667 When Administered Orally to Healthy Adult Participants
This study will be conducted to evaluate the effect of food on the single-dose pharmacokinetics and a drug-drug interaction evaluation of itraconazole and carbamazepine on INCB123667 when administered orally to healthy adult participants.
- Conditions
- Healthy Participants
- Being tested
- INCB123667, itraconazole, carbamazepine
- Keywords
- INCB123667
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB123667Drug
single dose administered orally
itraconazoleDrug
Oral: Tablet
carbamazepineDrug
Oral; Tablet
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Treatment A - INCB123667 Fasted | Experimental | INCB123667 will be administered at the protocol defined dose. Receives: Drug: INCB123667 |
| Cohort 1: Treatment B - INCB123667 Fed | Experimental | INCB123667 will be administered at the protocol defined dose. Receives: Drug: INCB123667 |
| Cohort 2: INCB123667 and itraconazole | Experimental | INCB123667 and itraconazole will be administered at protocol defined doses. Receives: Drug: INCB123667; Drug: itraconazole |
| Cohort 3: INCB123667 and carbamazepine | Experimental | INCB123667 and carbamazepine will be administered at protocol defined doses. Receives: Drug: INCB123667; Drug: carbamazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics Parameter (PK): Cmax of INCB123667
Defined as the maximum observed plasma or serum concentration.
Measured: Up to Day 16
Pharmacokinetics Parameter: Tmax of INCB123667
Defined as the time to maximum concentration.
Measured: Up to Day 16
Pharmacokinetics Parameter: AUCt of INCB123667
Defined as the area under the steady-state plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.
Measured: Up to Day 16
Pharmacokinetics Parameter: AUC∞ of INCB123667
Defined as the area under the single-dose plasma or serum concentration-time curve extrapolated to time of infinity.
Measured: Up to Day 16
Secondary outcomes (5)
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Defined as AEs reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
Measured: Up to Day 45
Pharmacokinetics Parameter: tmax of INCB123667
Defined as the time to maximum concentration.
Measured: Up to Day 16
Pharmacokinetics Parameter: t½ of INCB123667
Defined as the apparent terminal-phase disposition half-life.
Measured: Up to Day 16
Pharmacokinetics Parameter: CL/F of INCB123667
Defined as the apparent oral dose clearance.
Measured: Up to Day 16
Pharmacokinetics Parameter: Vz/F of INCB123667
Defined as the apparent oral dose volume of distribution.
Measured: Up to Day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start5 May 2025
- Primary completion17 May 2026
- Study completion17 May 2026
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 Incyte CorporationThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909162
- Sponsor's protocol ID
- INCB123667-102
- Status last verified
- Jun 2026
- First submitted
- 27 Mar 2025
- Last updated
- 15 Jun 2026
- Results posted
- 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 Jun 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 Food on the Single-Dose Pharmacokinetics and a Drug-Drug Interaction Evaluation of Itraconazole and Carbamazepine on INCB123667 When Administered Orally to Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06909162
- Acronym / sponsor ID
- INCB123667-102
- Conditions
- Healthy Participants
- Keywords
- INCB123667
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 5 May 2025 (actual)
- Primary completion
- 17 May 2026 (actual)
- Study completion
- 17 May 2026 (actual)
- First posted
- 3 Apr 2025 (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.
This study will be conducted to evaluate the effect of food on the single-dose pharmacokinetics and a drug-drug interaction evaluation of itraconazole and carbamazepine on INCB123667 when administered orally to healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Treatment A - INCB123667 Fasted | Experimental | Drug: INCB123667INCB123667 will be administered at the protocol defined dose. |
| Cohort 1: Treatment B - INCB123667 Fed | Experimental | Drug: INCB123667INCB123667 will be administered at the protocol defined dose. |
| Cohort 2: INCB123667 and itraconazole | Experimental | Drug: INCB123667, Drug: itraconazoleINCB123667 and itraconazole will be administered at protocol defined doses. |
| Cohort 3: INCB123667 and carbamazepine | Experimental | Drug: INCB123667, Drug: carbamazepineINCB123667 and carbamazepine will be administered at protocol defined doses. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Ability to comprehend and willingness to sign a written ICF for the study.
- Age 19 (in compliance with Nebraska state law) to 55 years, inclusive, at the time of signing the ICF.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive, at screening. Note: Only up to 25% of the participants may be enrolled with a BMI > 30 to ≤ 32.0 kg/m2.
- No clinically significant findings on screening evaluations (clinical, laboratory results [with the exception of lipids], and ECGs).
- Ability to swallow and retain oral tablets.
Key exclusion criteria (39 listed)
- History of uncontrolled or unstable cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening.
- History of an autoimmune disease diagnosis (i.e., myasthenia gravis).
- History of cardiovascular, cerebrovascular, peripheral vascular, or thrombotic disease or uncontrolled hypertension (systolic blood pressure > 140 mm Hg or diastolic blood pressure > 90 mm Hg at screening, confirmed by repeat testing).
- History or presence of an abnormal ECG before initial dose administration that, in the investigator's opinion, is clinically significant. Participants with a QTcF interval > 470 milliseconds (females) and > 450 milliseconds (males), QRS interval > 120 milliseconds, or PR interval > 220 milliseconds will be excluded. In the event a value is exclusionary, a single ECG will be repeated twice, and an average taken of the 3 readings will be used to determine if a participant should be excluded.
- Presence or history of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn's disease or chronic 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 |
|---|---|---|
| INCB123667single dose administered orally | Drug | Cohort 1: Treatment A - INCB123667 Fasted, Cohort 1: Treatment B - INCB123667 Fed, Cohort 2: INCB123667 and itraconazole, Cohort 3: INCB123667 and carbamazepine |
| itraconazoleOral: Tablet | Drug | Cohort 2: INCB123667 and itraconazole |
| carbamazepineOral; Tablet | Drug | Cohort 3: INCB123667 and carbamazepine |
Primary outcome
Pharmacokinetics Parameter (PK): Cmax of INCB123667
Time frame: Up to Day 16
Defined as the maximum observed plasma or serum concentration.
Pharmacokinetics Parameter: Tmax of INCB123667
Time frame: Up to Day 16
Defined as the time to maximum concentration.
Pharmacokinetics Parameter: AUCt of INCB123667
Time frame: Up to Day 16
Defined as the area under the steady-state plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.
Pharmacokinetics Parameter: AUC∞ of INCB123667
Time frame: Up to Day 16
Defined as the area under the single-dose plasma or serum concentration-time curve extrapolated to time of infinity.
5 secondary outcomes
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Day 45
Pharmacokinetics Parameter: tmax of INCB123667
Time frame: Up to Day 16
Pharmacokinetics Parameter: t½ of INCB123667
Time frame: Up to Day 16
Pharmacokinetics Parameter: CL/F of INCB123667
Time frame: Up to Day 16
Pharmacokinetics Parameter: Vz/F of INCB123667
Time frame: Up to Day 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- A Study to Evaluate the Effect of Food on the Single-Dose Pharmacokinetics of INCB123667 When Administered Orally to Healthy Adult ParticipantsLink provided by the sponsor.
- 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.
Incyte Medical Monitor study director
Incyte Corporation
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 INCB123667, itraconazole and carbamazepine in people with Healthy Participants, run by Incyte Corporation at 1 site in United States.
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 9 inclusion and 39 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: finished, as of the sponsor's last update on 15 Jun 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 States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pharmacokinetics Parameter (PK): Cmax of INCB123667 (time frame: Up to Day 16). 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 15 Jun 2026.