A Study to Evaluate the Bioequivalence of Ruxolitinib Extended Release (XR) Tablets With Ruxolitinib Immediate Release (IR) Tablets Administered Orally in Healthy Participants

NCT06555081 | Completed Phase 1 FDA Drug

• 1 other identifier: INCB018424-154
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducted to determine the Bioequivalence of Ruxolitinib XR 55 mg Tablets With Ruxolitinib IR Tablets Administered Orally in Healthy Participants

Conditions

Healthy Participants

Keywords

INCB018424; Ruxolitinib; Healthy Participants

Outcome Measures

Primary Outcomes (1)

• INCB018424 pharmacokinetic (PK) in Plasma

  INCB018424 concentration in plasma.

  Up to Day 16

Secondary Outcomes (2)

• Number of participants with Treatment Emergent Adverse Events (TEAEs)

  Up to Day 33

• Additional INCB018424 pharmacokinetic (PK) in Plasma

  Up to Day 16

Study Arms (4)

Period 1: Dose Treatment A

EXPERIMENTAL

Ruxolitinib IR will be administered at protocol defined dose.

Drug: Ruxolitinib IR

Period 1: Dose Treatment B

EXPERIMENTAL

Ruxolitinib XR will be administered at protocol defined dose.

Drug: Ruxolitinib XR

Period 2: Dose Treatment A

EXPERIMENTAL

Ruxolitinib IR will be administered at protocol defined dose.

Drug: Ruxolitinib IR

Period 2: Dose Treatment B

EXPERIMENTAL

Ruxolitinib XR will be administered at protocol defined dose.

Drug: Ruxolitinib XR

Interventions

Ruxolitinib IR DRUG

Tablet

Also known as: INCB018424

Period 1: Dose Treatment A; Period 2: Dose Treatment A

Ruxolitinib XR DRUG

Tablet

Also known as: INCB018424

Period 1: Dose Treatment B; Period 2: Dose Treatment B

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.
• Healthy adult participants aged 18 to 55 years, inclusive at screening.
• Body mass index between 18.0 and 32.0 kg/m2, inclusive, at screening. Note: Only up to 25% of the participants may be enrolled with a body mass index \> 30 to ≤ 32.0 kg/m2.
• No clinically significant findings on screening evaluations (clinical, laboratory, and ECG).
• Ability to swallow and retain oral medication.
• Willingness to avoid pregnancy or fathering children based on the criteria below.
• Male participants with reproductive potential must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) and not have a partner that is currently pregnant from screening through follow-up. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed.
• Female participants who are WOCBP must have a negative serum pregnancy test at screening and a negative serum or urine pregnancy test at check-in before the first dose on Day -1 and must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through follow-up. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed.
• Female participants of nonchildbearing potential (ie, surgically sterile with a hysterectomy and/or bilateral oophorectomy OR ≥ 12 months of amenorrhea and at least 51 years of age and FSH compatible with postmenopausal status) are eligible.

You may not qualify if:

• History of uncontrolled or unstable cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening.
• History of cardiovascular, cerebrovascular, peripheral vascular or thrombotic disease or uncontrolled hypertension (blood pressure \> 140/90 mmHg confirmed by repeat testing).
• Resting pulse \< 40 bpm or \> 100 bpm, confirmed by repeat testing.
• History or presence of an abnormal ECG before initial dose administration that, in the investigator's opinion, is clinically significant, such as a QTcF interval \> 460 msec for males and \> 470 msec for females.
• Presence of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn's disease or chronic pancreatitis).
• Hemoglobin, WBC count, platelet count, or absolute neutrophil count less than laboratory lower limit of normal at screening or at check-in, confirmed by repeat testing.
• 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's disease, for which total bilirubin must be ≤ 2.0 × ULN).
• History of malignancy within 5 years of screening, with the exception of cured basal cell or squamous cell carcinoma of the skin, ductal carcinoma in situ, or Gleason 6 prostate cancer.
• Current or recent (within 3 months of screening) clinically significant gastrointestinal disease or surgery (including cholecystectomy) that could affect the absorption of study drug except that appendectomy will be allowed.
• Any major surgery within 4 weeks of screening.
• Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of screening (within 2 weeks for plasma only).
• Blood transfusion within 4 weeks of check-in.
• Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment (includes latent treated tuberculosis).
• Positive test for hepatitis B virus, HCV, or HIV.
• History of significant alcohol use within 3 months before screening, defined as regular alcohol consumption \> 21 units per week for males and \> 14 units for females (1 unit = 8 oz of beer or a 25-mL shot of 40% spirit, 1.5 to 2 units = a 125-mL glass of wine, depending on type).

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (1)

Celerion Clinical Research Unit

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Interventions

ruxolitinib

Study Officials

• Incyte Medical 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

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 15, 2024
• Study Start: September 25, 2024
• Primary Completion: October 25, 2024
• Study Completion: November 7, 2024
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)