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

NCT06941077 | Completed Phase 1 FDA Drug

• 1 other identifier: INCB057643-111
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

INCB057643

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics Parameter (PK): Cmax of INCB057643

  Defined as maximum observed plasma concentration of INCB057643.

  Up to Day 10

• Pharmacokinetics Parameter: AUC(0-last) of INCB057643

  Defined as area under the single-dose serum concentration-time curve from time = 0 to the last measurable concentration at time of INCB057643.

  Up to Day 10

• Pharmacokinetics Parameter: AUC 0-∞ of INCB057643

  Defined as the area under the single-dose serum concentration-time curve extrapolated to time of infinity of INCB057643.

  Up to Day 10

Secondary Outcomes (7)

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

  Up to Day 26

• Pharmacokinetics Parameter: Tmax of INCB057643

  Up to Day 10

• Pharmacokinetics Parameter: t1/2 of INCB057643

  Up to Day 10

• Pharmacokinetics Parameter: CL/F INCB057643

  Up to Day 10

• Pharmacokinetics Parameter: V2/F of INCB057643

  Up to Day 10

Study Arms (5)

Cohort 1: Dose Treatment A

EXPERIMENTAL

INCB057643 will be administered at protocol defined dose.

Drug: INCB057643

Cohort 2: Dose Treatment B

EXPERIMENTAL

INCB057643 will be administered at protocol defined dose.

Drug: INCB057643

Cohort 3: Dose Treatment C

EXPERIMENTAL

INCB057643 will be administered at protocol defined dose.

Drug: INCB057643

Cohort 4: Dose Treatment D

EXPERIMENTAL

INCB057643 will be administered at protocol defined dose.

Drug: INCB057643

Cohort 4: Dose Treatment E

EXPERIMENTAL

INCB057643 will be administered at protocol defined dose.

Drug: INCB057643

Interventions

INCB057643 DRUG

Tablet

Cohort 1: Dose Treatment A; Cohort 2: Dose Treatment B; Cohort 3: Dose Treatment C; Cohort 4: Dose Treatment D; Cohort 4: Dose Treatment E

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (1)

Celerion, Inc

Tempe, Arizona, 85283, United States

Location

Related Links

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

MeSH Terms

Interventions

INCB057643

Study Officials

• Incyte Study Monitor

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cohorts 1-3 are single dose, and Cohort 4 is single dose, 2-way crossover.

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: April 23, 2025
• Study Start: May 12, 2025
• Primary Completion: June 3, 2025
• Study Completion: June 3, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)