> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-the-bioequivalence-of-ruxolitinib-cbb2b4ea-31e9-4464-9b43-aa21561611f1 > Record changed: 2026-10-13 # A Study to Evaluate the Bioequivalence of Ruxolitinib Extended Release (XR) Tablets With Ruxolitinib Immediate Release (IR) Tablets Administered Orally in Healthy Participants NCT06555081 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) Participants 168 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) Lead sponsor Incyte Corporation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) Start date 2024-09-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) ## Title and summary **Summary** This study is conducted to determine the Bioequivalence of Ruxolitinib XR 55 mg Tablets With Ruxolitinib IR Tablets Administered Orally in Healthy Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) **Short title** A Study to Evaluate the Bioequivalence of Ruxolitinib Extended Release (XR) Tablets With Ruxolitinib Immediate Release (IR) Tablets Administered Orally in Healthy Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) **Official title** Bioequivalence of Ruxolitinib XR Tablets With Ruxolitinib IR Tablets Administered Orally in Healthy Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) ## Dates **Completion date** 2024-11-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) **First posted** 2024-08-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) **Registry last updated** 2025-02-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) **Primary completion date** 2024-10-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) **Start date** 2024-09-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) ## Size and sites **Actual participants** 168 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) **Participants** 168 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) **Lead sponsor** Incyte Corporation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) ## Identifiers **Registry ID** NCT06555081 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) **ClinicalTrials.gov ID** NCT06555081 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) ## Study design **Allocation** Randomised **Model** Crossover **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) ## Outcomes ### Primary outcomes 1. INCB018424 pharmacokinetic (PK) in Plasma Timeframe: Up to Day 16 INCB018424 concentration in plasma. ### Secondary outcomes 1. Number of participants with Treatment Emergent Adverse Events (TEAEs) Timeframe: Up to Day 33 Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug. 2. Additional INCB018424 pharmacokinetic (PK) in Plasma Timeframe: Up to Day 16 Additional INCB018424 concentration in plasma. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **Healthy volunteers** Yes ### Inclusion criteria - 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. ### 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 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). - Positive urine or breath test for ethanol or positive urine 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 Protocol. - Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug with an inducer or inhibitor of cytochrome P450 3A4, P-glycoprotein, or breast cancer resistance protein. - Current use of prohibited medication. - History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator. - Known hypersensitivity or severe reaction to ruxolitinib or any excipients of ruxolitinib. - Inability to undergo venipuncture or tolerate venous access as assessed by the investigator. - Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations, in the opinion of the investigator. - Use of tobacco- or nicotine-containing products within 14 days of screening and throughout the study. - Use of prescription drugs (including oral contraceptives) within 14 days of study drug administration or nonprescription medications/products (vitamins, minerals, and phytotherapeutic/herbal/plant derived preparations) within 7 days of study drug administration and throughout the study except for permitted medications during the study. - Women who are pregnant or breastfeeding at screening or check-in. - Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. - eGFR < 80 mL/min/1.73 m2 at screening, based on the site's standard formula. - Any condition that would jeopardize the safety of the participant or compliance with the Protocol. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) ## Sites - Celerion Clinical Research UnitTempe, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06555081) ## Related records ### Drugs (1) - [Ruxolitinib phosphate](https://trialight.com/data/asset/ruxolitinib-phosphate-fce80c56-88a2-456a-bcb5-431e98979584.md) ### Lead sponsors (1) - [Incyte Corporation](https://trialight.com/data/company/incyte-corporation-e1151708-5233-40b6-a85b-04abb2816a9f.md) ### Targets (2) - [JAK1](https://trialight.com/data/target/jak1-c22a6fc9-26d6-5daa-a0f4-71cd08b3c5e1.md) - [JAK2](https://trialight.com/data/target/jak2-6d06f09e-903b-5a13-9d7a-79efa991190f.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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