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CompletedNCT07018635Updated Nov 26, 2025

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 interventional study of INCB161734 and Itraconazole in Healthy Participants, sponsored by Incyte Corporation. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-26.

Sponsored by Incyte Corporation · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Sep 2025, 1 year ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
63
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Participants

Keywords

  • INCB161734
03

In context

Lead sponsor

Incyte Corporation is the lead sponsor of 286 studies on the registry; 37 are open to participants now.

Of its 144 completed or terminated interventional studies of FDA-regulated products, 93 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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).
  • 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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    Cohort 1

    INCB161734 and itraconazole will be administered at protocol defined doses.

    Drug: INCB161734 · Drug: Itraconazole

  • Experimental
    Cohort 2

    INCB161734 and rifampin will be administered at protocol defined doses.

    Drug: INCB161734 · Drug: Rifampin

  • Experimental
    Cohort 3

    INCB161734 and esomeprazole will be administered at protocol defined doses.

    Drug: INCB161734 · Drug: Esomeprazole

  • Experimental
    Cohort 4

    INCB161734 and famotidine will be administered at protocol defined doses.

    Drug: INCB161734 · Drug: Famotidine

Interventions

  • DrugINCB161734

    Oral; Tablet

  • DrugItraconazole

    Oral; Tablet

  • DrugRifampin

    Oral; Tablet

  • DrugEsomeprazole

    Oral; Tablet

  • DrugFamotidine

    Oral; Tablet

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics Parameter (PK): Cmax of INCB161734

    Defined as maximum observed plasma or serum concentration of INCB161734.

    Time frame: Up to 2 months

  2. Pharmacokinetics Parameter: AUC(0-t) of INCB161734

    Defined as the area under the concentration-time curve up to the last measurable concentration of INCB161734.

    Time frame: Up to 2 months

  3. Pharmacokinetics Parameter: AUC 0-∞ of INCB161734

    Defined as the area under the concentration-time curve from 0 to infinity of INCB161734.

    Time frame: Up to 2 months

Secondary outcomes

  1. 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.

    Time frame: Up to 2 months

  2. Pharmacokinetics Parameter: Tmax of INCB161734

    Defined as the time to reach the maximum plasma concentration of INCB161734.

    Time frame: Up to 2 months

  3. Pharmacokinetics Parameter: t1/2 of INCB161734

    Defined as the apparent terminal phase disposition half-life of INCB161734.

    Time frame: Up to 2 months

  4. Pharmacokinetics Parameter: CL/V of INCB161734

    Defined as the apparent oral dose clearance of INCB161734.

    Time frame: Up to 2 months

  5. Pharmacokinetics Parameter: Vz/F of INCB161734

    Defined as the apparent oral dose volume of distribution of INCB161734.

    Time frame: Up to 2 months

  6. 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.

    Time frame: Up to 2 months

07

Study locations

1 site
  • Fortrea Clinical Research Unit Ltd Labcorp Clinical Research Unit Limited Madison
    Madison, Wisconsin 53704, United States
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07018635
Lead sponsor
Incyte Corporation
Responsible party
Sponsor
First posted
Jun 12, 2025
Start date
Jul 16, 2025
Primary completion
Sep 29, 2025
Completion
Sep 29, 2025
Last update
Nov 26, 2025

Study contacts

Incyte Medical Monitor
study director · Incyte Corporation

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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