Healthy ParticipantsPhase 1NCT07018635
A Study to Assess the Effect of Itraconazole, Rifampin, and Acid-Reducing Agents on INCB161734 Pharmacokinetics When Administered Orally in Healthy Participants
A Phase 1 study testing INCB161734, Itraconazole and Rifampin in people with Healthy Participants, run by Incyte Corporation at 1 site in United States.
Trial summary
This study is conducted to assess the effect of itraconazole, rifampin, and acid-reducing agents on INCB161734 pharmacokinetics when administered orally 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?
- INCB161734, Itraconazole and Rifampin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2025to 29 Sep 2025
- 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 18 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 18 to 55 years, inclusive, at the time of signing the ICF.
- Body mass index between 18.0 and 32.0 kg/m2 (inclusive).
- Willingness to adhere to study-related prohibitions, restrictions, and procedures.
- Ability to swallow and retain PO medication.
- Willingness to avoid pregnancy or fathering children based on the criteria defined in the prootcol.
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 rheumatologic/autoimmune disorders and immune deficiency/immunologic defects.
- History of major bleeding or thrombosis, including myocardial infarction/stroke and pulmonary embolism/deep vein thrombosis.
- Known tuberculosis infection that is active or participant-reported history of tuberculosis or treatment thereof.
- Resting pulse < 40 bpm or > 100 bpm, confirmed by repeat testing at screening.
- Presence of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn disease or chronic pancreatitis).
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- Any major surgery within 12 weeks of screening.
- Positive test for hepatitis B virus, hepatitis C virus, or HIV. Note: Participants whose results are compatible with prior immunization or immunity due to infection for hepatitis B may be included at the discretion of the investigator.
- Positive urine or breath test for ethanol or positive urine or serum screen for drugs of abuse that are not otherwise explained by permitted concomitant medications or diet.
- Use of tobacco- or nicotine-containing products within 1 month of screening.
- Women who are pregnant or breastfeeding.
- eGFR < 90 mL/min/1.73 m2 based on the CKD-EPI equation.
- Any history of hypersensitivity or intolerance to itraconazole, rifampin, esomeprazole or any other PPI, or famotidine or any other H2 antagonist.
- Other protocol-defined Inclusion/Exclusion Criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fortrea Clinical Research Unit Ltd Labcorp Clinical Research Unit Limited Madison
Madison, Wisconsin, 53704
About this study
Official title: An Open-Label Study to Assess the Effect of Itraconazole, Rifampin, and Acid-Reducing Agents on INCB161734 Pharmacokinetics When Administered Orally in Healthy Participants
This study is conducted to assess the effect of itraconazole, rifampin, and acid-reducing agents on INCB161734 pharmacokinetics when administered orally in healthy participants.
- Conditions
- Healthy Participants
- Being tested
- INCB161734, Itraconazole, Rifampin, Esomeprazole, Famotidine
- Keywords
- INCB161734
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB161734Drug
Oral; Tablet
ItraconazoleDrug
Oral; Tablet
RifampinDrug
Oral; Tablet
EsomeprazoleDrug
Oral; Tablet
FamotidineDrug
Oral; Tablet
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | INCB161734 and itraconazole will be administered at protocol defined doses. Receives: Drug: INCB161734; Drug: Itraconazole |
| Cohort 2 | Experimental | INCB161734 and rifampin will be administered at protocol defined doses. Receives: Drug: INCB161734; Drug: Rifampin |
| Cohort 3 | Experimental | INCB161734 and esomeprazole will be administered at protocol defined doses. Receives: Drug: INCB161734; Drug: Esomeprazole |
| Cohort 4 | Experimental | INCB161734 and famotidine will be administered at protocol defined doses. Receives: Drug: INCB161734; Drug: Famotidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics Parameter (PK): Cmax of INCB161734
Defined as maximum observed plasma or serum concentration of INCB161734.
Measured: Up to 2 months
Pharmacokinetics Parameter: AUC(0-t) of INCB161734
Defined as the area under the concentration-time curve up to the last measurable concentration of INCB161734.
Measured: Up to 2 months
Pharmacokinetics Parameter: AUC 0-∞ of INCB161734
Defined as the area under the concentration-time curve from 0 to infinity of INCB161734.
Measured: Up to 2 months
Secondary outcomes (6)
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Defined as adverse events reported for the first time or the worsening of a pre-existing event, occurring after first dose of study drug.
Measured: Up to 2 months
Pharmacokinetics Parameter: Tmax of INCB161734
Defined as the time to reach the maximum plasma concentration of INCB161734.
Measured: Up to 2 months
Pharmacokinetics Parameter: t1/2 of INCB161734
Defined as the apparent terminal phase disposition half-life of INCB161734.
Measured: Up to 2 months
Pharmacokinetics Parameter: CL/V of INCB161734
Defined as the apparent oral dose clearance of INCB161734.
Measured: Up to 2 months
Pharmacokinetics Parameter: Vz/F of INCB161734
Defined as the apparent oral dose volume of distribution of INCB161734.
Measured: Up to 2 months
Pharmacokinetics Parameter: AUC%extrap of INCB161734
Defined as percentage of AUC∞ (_obs, _pred) due to extrapolation from time of last measurable observed concentration to infinity of INCB161734.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start16 Jul 2025
- Primary completion29 Sep 2025
- Study completion29 Sep 2025
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 63 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
- NCT07018635
- Sponsor's protocol ID
- INCB161734-103
- Status last verified
- Nov 2025
- First submitted
- 4 Jun 2025
- Last updated
- 26 Nov 2025
- 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 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Assess the Effect of Itraconazole, Rifampin, and Acid-Reducing Agents on INCB161734 Pharmacokinetics When Administered Orally in Healthy Participants
- ClinicalTrials.gov ID
- NCT07018635
- Acronym / sponsor ID
- INCB161734-103
- Conditions
- Healthy Participants
- Keywords
- INCB161734
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- 29 Sep 2025 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 12 Jun 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 is conducted to assess the effect of itraconazole, rifampin, and acid-reducing agents on INCB161734 pharmacokinetics when administered orally in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: INCB161734, Drug: ItraconazoleINCB161734 and itraconazole will be administered at protocol defined doses. |
| Cohort 2 | Experimental | Drug: INCB161734, Drug: RifampinINCB161734 and rifampin will be administered at protocol defined doses. |
| Cohort 3 | Experimental | Drug: INCB161734, Drug: EsomeprazoleINCB161734 and esomeprazole will be administered at protocol defined doses. |
| Cohort 4 | Experimental | Drug: INCB161734, Drug: FamotidineINCB161734 and famotidine will be administered at protocol defined doses. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Ability to comprehend and willingness to sign a written ICF for the study.
- Age 18 to 55 years, inclusive, at the time of signing the ICF.
- Body mass index between 18.0 and 32.0 kg/m2 (inclusive).
- Willingness to adhere to study-related prohibitions, restrictions, and procedures.
- Ability to swallow and retain PO medication.
Key exclusion criteria (14 listed)
- History of uncontrolled or unstable cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening.
- History of rheumatologic/autoimmune disorders and immune deficiency/immunologic defects.
- History of major bleeding or thrombosis, including myocardial infarction/stroke and pulmonary embolism/deep vein thrombosis.
- Known tuberculosis infection that is active or participant-reported history of tuberculosis or treatment thereof.
- Resting pulse < 40 bpm or > 100 bpm, confirmed by repeat testing at screening.
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 |
|---|---|---|
| INCB161734Oral; Tablet | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| ItraconazoleOral; Tablet | Drug | Cohort 1 |
| RifampinOral; Tablet | Drug | Cohort 2 |
| EsomeprazoleOral; Tablet | Drug | Cohort 3 |
| FamotidineOral; Tablet | Drug | Cohort 4 |
Primary outcome
Pharmacokinetics Parameter (PK): Cmax of INCB161734
Time frame: Up to 2 months
Defined as maximum observed plasma or serum concentration of INCB161734.
Pharmacokinetics Parameter: AUC(0-t) of INCB161734
Time frame: Up to 2 months
Defined as the area under the concentration-time curve up to the last measurable concentration of INCB161734.
Pharmacokinetics Parameter: AUC 0-∞ of INCB161734
Time frame: Up to 2 months
Defined as the area under the concentration-time curve from 0 to infinity of INCB161734.
6 secondary outcomes
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 2 months
Pharmacokinetics Parameter: Tmax of INCB161734
Time frame: Up to 2 months
Pharmacokinetics Parameter: t1/2 of INCB161734
Time frame: Up to 2 months
Pharmacokinetics Parameter: CL/V of INCB161734
Time frame: Up to 2 months
Pharmacokinetics Parameter: Vz/F of INCB161734
Time frame: Up to 2 months
Pharmacokinetics Parameter: AUC%extrap of INCB161734
Time frame: Up to 2 months
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 26 Nov 2025.
- A study to Assess the Effect of Itraconazole, Rifampin, and Acid-Reducing Agents on INCB161734 Pharmacokinetics When Administered Orally in Healthy 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 INCB161734, Itraconazole and Rifampin 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 6 inclusion and 14 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 26 Nov 2025. 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 INCB161734 (time frame: Up to 2 months). 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 26 Nov 2025.