Status:
COMPLETED
A Study to Evaluate the Bioequivalence of Ruxolitinib Extended Release (XR) Tablets With Ruxolitinib Immediate Release (IR) Tablets Administered Orally in Healthy Participants
Lead Sponsor:
Incyte Corporation
Conditions:
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2024
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT06555081
Start Date
September 25 2024
End Date
November 7 2024
Last Update
February 13 2025
Active Locations (1)
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1
Celerion Clinical Research Unit
Tempe, Arizona, United States, 85283