A Study to Assess the Effect of Itraconazole, Rifampin, and Acid-Reducing Agents on INCB161734 Pharmacokinetics When Administered Orally in Healthy Participants

NCT07018635 | Completed Phase 1 FDA Drug

• 1 other identifier: INCB161734-103
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants

Keywords

INCB161734

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics Parameter (PK): Cmax of INCB161734

  Defined as maximum observed plasma or serum concentration of INCB161734.

  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.

  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.

  Up to 2 months

Secondary Outcomes (6)

• Number of participants with Treatment-emergent Adverse Events (TEAEs)

  Up to 2 months

• Pharmacokinetics Parameter: Tmax of INCB161734

  Up to 2 months

• Pharmacokinetics Parameter: t1/2 of INCB161734

  Up to 2 months

• Pharmacokinetics Parameter: CL/V of INCB161734

  Up to 2 months

• Pharmacokinetics Parameter: Vz/F of INCB161734

  Up to 2 months

Study Arms (4)

Cohort 1

EXPERIMENTAL

INCB161734 and itraconazole will be administered at protocol defined doses.

Drug: INCB161734; Drug: Itraconazole

Cohort 2

EXPERIMENTAL

INCB161734 and rifampin will be administered at protocol defined doses.

Drug: INCB161734; Drug: Rifampin

Cohort 3

EXPERIMENTAL

INCB161734 and esomeprazole will be administered at protocol defined doses.

Drug: INCB161734; Drug: Esomeprazole

Cohort 4

EXPERIMENTAL

INCB161734 and famotidine will be administered at protocol defined doses.

Drug: INCB161734; Drug: Famotidine

Interventions

INCB161734 DRUG

Oral; Tablet

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Itraconazole DRUG

Oral; Tablet

Cohort 1

Rifampin DRUG

Oral; Tablet

Cohort 2

Esomeprazole DRUG

Oral; Tablet

Cohort 3

Famotidine DRUG

Oral; Tablet

Cohort 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (1)

Fortrea Clinical Research Unit Ltd Labcorp Clinical Research Unit Limited Madison

Madison, Wisconsin, 53704, United States

Location

Related Links

• A study to Assess the Effect of Itraconazole, Rifampin, and Acid-Reducing Agents on INCB161734 Pharmacokinetics When Administered Orally in Healthy Participants

MeSH Terms

Interventions

Itraconazole; Rifampin; Esomeprazole; Famotidine

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Thiazoles

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 12, 2025
• Study Start: July 16, 2025
• Primary Completion: September 29, 2025
• Study Completion: September 29, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)