Healthy Participants
Conditions
Keywords
INCB161734
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.
Interventions
DRUGINCB161734
Oral; Tablet
DRUGItraconazole
Oral; Tablet
DRUGRifampin
Oral; Tablet
DRUGEsomeprazole
Oral; Tablet
DRUGFamotidine
Oral; Tablet
Sponsors
Incyte Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
* 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics Parameter (PK): Cmax of INCB161734 | Up to 2 months | Defined as maximum observed plasma or serum concentration of INCB161734. |
| Pharmacokinetics Parameter: AUC(0-t) of INCB161734 | 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 | Up to 2 months | Defined as the area under the concentration-time curve from 0 to infinity of INCB161734. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics Parameter: Tmax of INCB161734 | Up to 2 months | Defined as the time to reach the maximum plasma concentration of INCB161734. |
| Pharmacokinetics Parameter: CL/V of INCB161734 | Up to 2 months | Defined as the apparent oral dose clearance of INCB161734. |
| Pharmacokinetics Parameter: AUC%extrap of INCB161734 | 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. |
| Pharmacokinetics Parameter: t1/2 of INCB161734 | Up to 2 months | Defined as the apparent terminal phase disposition half-life of INCB161734. |
| Pharmacokinetics Parameter: Vz/F of INCB161734 | Up to 2 months | Defined as the apparent oral dose volume of distribution of INCB161734. |
| Number of participants with Treatment-emergent Adverse Events (TEAEs) | 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. |
Countries
United States
Outcome results
None listed