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Completed

NCT Number: NCT07018635

A 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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit Ltd Labcorp Clinical Research Unit Limited Madison

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

INCB161734

Drug

Oral; Tablet

Itraconazole

Drug

Oral; Tablet

Rifampin

Drug

Oral; Tablet

Esomeprazole

Drug

Oral; Tablet

Famotidine

Drug

Oral; Tablet

Primary outcomes

  1. Pharmacokinetics Parameter (PK): Cmax of INCB161734

    Time frame: Up to 2 months

    Defined as maximum observed plasma or serum concentration of INCB161734.

  2. 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.

  3. 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.

Secondary outcomes

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

    Time frame: Up to 2 months

    Defined as adverse events reported for the first time or the worsening of a pre-existing event, occurring after first dose of study drug.

  2. Pharmacokinetics Parameter: Tmax of INCB161734

    Time frame: Up to 2 months

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

  3. Pharmacokinetics Parameter: t1/2 of INCB161734

    Time frame: Up to 2 months

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

  4. Pharmacokinetics Parameter: CL/V of INCB161734

    Time frame: Up to 2 months

    Defined as the apparent oral dose clearance of INCB161734.

  5. Pharmacokinetics Parameter: Vz/F of INCB161734

    Time frame: Up to 2 months

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

  6. Pharmacokinetics Parameter: AUC%extrap of INCB161734

    Time frame: Up to 2 months

    Defined as percentage of AUC∞ (_obs, _pred) due to extrapolation from time of last measurable observed concentration to infinity of INCB161734.

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 12, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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