COMPLETED

A Study to Evaluate the Relative Bioavailability of New Formulations of INCB057643 Tablets Administered Orally in Healthy Participants

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the Relative Bioavailability of New Formulations of INCB057643 Tablets Administered Orally in Healthy Participants.

Official Title

Relative Bioavailability of New Formulations of INCB057643 Tablets Administered Orally in Healthy Participants

Quick Facts

Study Start:2025-05-12

Study Completion:2025-06-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06941077

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Ability to comprehend and willingness to sign a written ICF for the study. * Aged 18 to 55 years, inclusive, at the time of signing the ICF. * BMI within the range of 18.0 to 30.0 kg/m2 inclusive. Note: Up to 25% of the participants in each cohort may be enrolled with a BMI \> 30 to ≤ 32.0 kg/m2. * No clinically significant findings on screening evaluations (clinical, laboratory, and ECG). * Ability to swallow and retain oral medication.	* History of uncontrolled or unstable respiratory, renal, GI, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening. * History of cardiovascular, cerebrovascular, peripheral vascular, or thrombotic disease or uncontrolled hypertension. * High blood pressure (systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg at screening, confirmed by repeat testing). * History or presence of an abnormal ECG before screening and check-in that, in the investigator's opinion, is clinically significant, such as a QTcF interval \> 450 milliseconds, QRS interval \> 120 milliseconds, or PR interval \> 220 milliseconds. * History or presence of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn disease or chronic pancreatitis). * Hepatic transaminases (ALT and AST), ALP, or total bilirubin \> 1.25 × the laboratory-defined ULN at screening and check-in, confirmed by repeat testing (except participants with Gilbert disease, for which total bilirubin must be ≤ 2.0 × ULN). * Any major surgery within 4 weeks of screening. * Current or recent (within 3 months of screening) clinically significant GI disease or surgery (including cholecystectomy and excluding appendectomy) that could affect the absorption of study drug. * Donation of blood to a blood bank or participation in a clinical study (except a screening visit) within 4 weeks of screening (within 2 weeks for donation of plasma only). * Positive test for HBV, HCV, or HIV. Participants whose results are compatible with prior immunization for or immunity due to infection with HBV may be included at the discretion of the investigator. * History of significant alcohol use, defined as regular alcohol consumption \> 21 units per week for males and \> 14 units for females (1 unit = 8 ounces of beer or a 25-mL shot of 40% spirit, 1.5 to 2 units = 125-mL glass of wine, depending on type). * 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. * Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug with another investigational medication or current enrollment in another investigational drug or investigational product study. * History of tobacco or nicotine-containing product use within 1 month of screening. * Use of prescription drugs (including hormonal contraceptives) within 14 days of study drug administration or nonprescription medications/products (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days of study drug administration. However, occasional and standard-dose acetaminophen and ibuprofen and standard-dose vitamins are permitted. Megadose vitamins or supplements are not permissible.

Inclusion Criteria

Exclusion Criteria

* Ability to comprehend and willingness to sign a written ICF for the study.
* Aged 18 to 55 years, inclusive, at the time of signing the ICF.
* BMI within the range of 18.0 to 30.0 kg/m2 inclusive. Note: Up to 25% of the participants in each cohort may be enrolled with a BMI \> 30 to ≤ 32.0 kg/m2.
* No clinically significant findings on screening evaluations (clinical, laboratory, and ECG).
* Ability to swallow and retain oral medication.

* History of uncontrolled or unstable respiratory, renal, GI, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening.
* History of cardiovascular, cerebrovascular, peripheral vascular, or thrombotic disease or uncontrolled hypertension.
* High blood pressure (systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg at screening, confirmed by repeat testing).
* History or presence of an abnormal ECG before screening and check-in that, in the investigator's opinion, is clinically significant, such as a QTcF interval \> 450 milliseconds, QRS interval \> 120 milliseconds, or PR interval \> 220 milliseconds.
* History or presence of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn disease or chronic pancreatitis).
* Hepatic transaminases (ALT and AST), ALP, or total bilirubin \> 1.25 × the laboratory-defined ULN at screening and check-in, confirmed by repeat testing (except participants with Gilbert disease, for which total bilirubin must be ≤ 2.0 × ULN).
* Any major surgery within 4 weeks of screening.
* Current or recent (within 3 months of screening) clinically significant GI disease or surgery (including cholecystectomy and excluding appendectomy) that could affect the absorption of study drug.
* Donation of blood to a blood bank or participation in a clinical study (except a screening visit) within 4 weeks of screening (within 2 weeks for donation of plasma only).
* Positive test for HBV, HCV, or HIV. Participants whose results are compatible with prior immunization for or immunity due to infection with HBV may be included at the discretion of the investigator.
* History of significant alcohol use, defined as regular alcohol consumption \> 21 units per week for males and \> 14 units for females (1 unit = 8 ounces of beer or a 25-mL shot of 40% spirit, 1.5 to 2 units = 125-mL glass of wine, depending on type).
* 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.
* Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug with another investigational medication or current enrollment in another investigational drug or investigational product study.
* History of tobacco or nicotine-containing product use within 1 month of screening.
* Use of prescription drugs (including hormonal contraceptives) within 14 days of study drug administration or nonprescription medications/products (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days of study drug administration. However, occasional and standard-dose acetaminophen and ibuprofen and standard-dose vitamins are permitted. Megadose vitamins or supplements are not permissible.

Contacts and Locations

Principal Investigator

Incyte Study Monitor

STUDY_DIRECTOR

Incyte Corporation

Study Locations (Sites)

Celerion, Inc

Tempe, Arizona, 85283

United States

Collaborators and Investigators

Sponsor: Incyte Corporation

Incyte Study Monitor, STUDY_DIRECTOR, Incyte Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-12

Study Completion Date2025-06-03

Study Record Updates

Study Start Date2025-05-12

Study Completion Date2025-06-03

Terms related to this study

Keywords Provided by Researchers

INCB057643

Additional Relevant MeSH Terms

Healthy Volunteers