A Study to Assess the Effect of Itraconazole, Rifampin, a... | NCT07018635

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
INCB161734	Drug	Oral; Tablet	Cohort 1 Cohort 2 Cohort 3 Cohort 4

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.	Up to 2 months
Pharmacokinetics Parameter: Tmax of INCB161734

Eligibility Module

Eligibility Criteria

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.

Name	Affiliation	Role
Incyte Medical Monitor	Incyte Corporation	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Fortrea Clinical Research Unit Ltd Labcorp Clinical Research Unit Limited Madison		Madison	Wisconsin	53704	United States

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

Ancestor Terms

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D010879	Piperazines
D012294	Rifamycins
D006576	Heterocyclic Compounds, 4 or More Rings
D000072471	Heterocyclic Compounds, Fused-Ring
D047029	Lactams, Macrocyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D009853	Omeprazole
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds
D009930	Organic Chemicals
D011725	Pyridines
D001562	Benzimidazoles
D006574	Heterocyclic Compounds, 2-Ring
D013844	Thiazoles