Healthy ParticipantsPhase 1NCT06555081
A Study to Evaluate the Bioequivalence of Ruxolitinib Extended Release (XR) Tablets With Ruxolitinib Immediate Release (IR) Tablets Administered Orally in Healthy Participants
A Phase 1 study testing Ruxolitinib IR and Ruxolitinib XR in people with Healthy Participants, run by Incyte Corporation at 1 site in United States.
Trial summary
This study is conducted to determine the Bioequivalence of Ruxolitinib XR 55 mg Tablets With Ruxolitinib IR Tablets Administered Orally in Healthy Participants Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Ruxolitinib IR and Ruxolitinib XR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2024to 7 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Celerion Clinical Research Unit
Tempe, Arizona, 85283
About this study
Official title: Bioequivalence of Ruxolitinib XR Tablets With Ruxolitinib IR Tablets Administered Orally in Healthy Participants
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
- Being tested
- Ruxolitinib IR, Ruxolitinib XR
- Keywords
- INCB018424, Ruxolitinib, Healthy Participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ruxolitinib IRDrug
Also called INCB018424
Tablet
Ruxolitinib XRDrug
Also called INCB018424
Tablet
| Study group | Role | What they receive |
|---|---|---|
| Period 1: Dose Treatment A | Experimental | Ruxolitinib IR will be administered at protocol defined dose. Receives: Drug: Ruxolitinib IR |
| Period 1: Dose Treatment B | Experimental | Ruxolitinib XR will be administered at protocol defined dose. Receives: Drug: Ruxolitinib XR |
| Period 2: Dose Treatment A | Experimental | Ruxolitinib IR will be administered at protocol defined dose. Receives: Drug: Ruxolitinib IR |
| Period 2: Dose Treatment B | Experimental | Ruxolitinib XR will be administered at protocol defined dose. Receives: Drug: Ruxolitinib XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
INCB018424 pharmacokinetic (PK) in Plasma
INCB018424 concentration in plasma.
Measured: Up to Day 16
Secondary outcomes (2)
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
Measured: Up to Day 33
Additional INCB018424 pharmacokinetic (PK) in Plasma
Additional INCB018424 concentration in plasma.
Measured: Up to Day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start25 Sep 2024
- Primary completion25 Oct 2024
- Study completion7 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555081
- Sponsor's protocol ID
- INCB018424-154
- Status last verified
- Feb 2025
- First submitted
- 12 Aug 2024
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence of Ruxolitinib XR Tablets With Ruxolitinib IR Tablets Administered Orally in Healthy Participants
- ClinicalTrials.gov ID
- NCT06555081
- Acronym / sponsor ID
- INCB018424-154
- Conditions
- Healthy Participants
- Keywords
- INCB018424, Ruxolitinib, Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 25 Oct 2024 (actual)
- Study completion
- 7 Nov 2024 (actual)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is conducted to determine the Bioequivalence of Ruxolitinib XR 55 mg Tablets With Ruxolitinib IR Tablets Administered Orally in Healthy Participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Period 1: Dose Treatment A | Experimental | Drug: Ruxolitinib IRRuxolitinib IR will be administered at protocol defined dose. |
| Period 1: Dose Treatment B | Experimental | Drug: Ruxolitinib XRRuxolitinib XR will be administered at protocol defined dose. |
| Period 2: Dose Treatment A | Experimental | Drug: Ruxolitinib IRRuxolitinib IR will be administered at protocol defined dose. |
| Period 2: Dose Treatment B | Experimental | Drug: Ruxolitinib XRRuxolitinib XR will be administered at protocol defined dose. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (29 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ruxolitinib IRAlso: INCB018424Tablet | Drug | Period 1: Dose Treatment A, Period 2: Dose Treatment A |
| Ruxolitinib XRAlso: INCB018424Tablet | Drug | Period 1: Dose Treatment B, Period 2: Dose Treatment B |
Primary outcome
INCB018424 pharmacokinetic (PK) in Plasma
Time frame: Up to Day 16
INCB018424 concentration in plasma.
2 secondary outcomes
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Day 33
Additional INCB018424 pharmacokinetic (PK) in Plasma
Time frame: Up to Day 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Incyte Medical Monitor study director
Incyte Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ruxolitinib IR and Ruxolitinib XR in people with Healthy Participants, run by Incyte Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
INCB018424 pharmacokinetic (PK) in Plasma (time frame: Up to Day 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.