Evaluating new formulations of INCB057643 tablets in healthy volunteers

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

This study tests new versions of INCB057643 tablets in healthy adults to see how well their bodies absorb the medication.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Incyte Corporation (Industry-sponsored)
• Locations: 1 site (Tempe, Arizona)
• Trial ID: NCT06941077 on ClinicalTrials.gov

What this trial studies

This study aims to assess the relative bioavailability of new formulations of INCB057643 tablets when administered orally to healthy participants. It involves healthy volunteers aged 18 to 55, who will be monitored for their ability to absorb and retain the medication. The study will include various screening evaluations to ensure participants meet health criteria and can safely participate. The findings will help determine the effectiveness of the new tablet formulations.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 to 55 with a BMI between 18.0 and 30.0 kg/m2.

Not a fit: Patients with significant health issues or those outside the specified age and BMI range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved formulations of INCB057643 that enhance patient outcomes.

How similar studies have performed: While this study focuses on a specific formulation, similar studies evaluating bioavailability have shown success in optimizing drug delivery methods.

Eligibility criteria

Inclusion 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.

Exclusion Criteria:

* 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.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Where this trial is running

Tempe, Arizona

• Celerion, Inc — Tempe, Arizona, United States (Recruiting)

Study contacts

• Study coordinator: Incyte Corporation Call Center (US)

Conditions Healthy Volunteers; INCB057643