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Healthy ParticipantsPhase 1NCT06310304

A Study to Evaluate the Relative Bioavailability of Ruxolitinib Extended Release (XR) Tablets Compared 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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is conducted to determine the Relative Bioavailability of Ruxolitinib XR Tablets Compared With Ruxolitinib IR Tablets Administered Orally in Healthy Participants. Read more about this study

Who is it for?
Ages 19 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
24 participants
Where
1 siteUnited States
Study dates
26 Mar 2024to 15 May 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 19 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 19 to 55 years at screening.
  • Body mass index between 18.0 and 32.0 kg/m2, inclusive, at screening. Note: Only up to 25% of the participants in each cohort 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 < 45 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 > 450 milliseconds.
  • 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. Participants whose results are compatible with prior immunization or immunity due to infection for hepatitis B may be included at the discretion of the investigator.
  • History of alcoholism within 3 months of screening.
  • 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.
  • 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 1 month of screening and throughout the study.
  • Use of prescription drugs 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 and throughout the study except for permitted medications during the study.
  • Women who are pregnant or breastfeeding.
  • 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 < 90 mL/min/1.73 m2 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, Inc

    Lincoln, Nebraska, 68502

Other trials in United States

About this study

Official title: Relative Bioavailability of Ruxolitinib XR Tablets Compared With Ruxolitinib IR Tablets Administered Orally in Healthy Participants

This study is conducted to determine the Relative Bioavailability of Ruxolitinib XR Tablets Compared With Ruxolitinib IR Tablets Administered Orally in 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 groups in NCT06310304
Study groupRoleWhat they receive
Cohort 1: Dose Treatment AExperimentalRuxolitinib IR will be administered at protocol defined dose.
Receives: Drug: Ruxolitinib IR
Cohort 1: Dose Treatment BExperimentalRuxolitinib XR will be administered at protocol defined dose.
Receives: Drug: Ruxolitinib XR
Cohort 2: Dose Treatment AExperimentalRuxolitinib IR will be administered at protocol defined dose.
Receives: Drug: Ruxolitinib IR
Cohort 2: Dose Treatment BExperimentalRuxolitinib 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.

  1. INCB018424 pharmacokinetic (PK) in Plasma

    INCB018424 concentration in plasma.

    Measured: Up to Day 22

Secondary outcomes (2)

  1. 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 55

  2. Additional INCB018424 pharmacokinetic (PK) in Plasma

    Additional INCB018424 concentration in plasma.

    Measured: Up to Day 22

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2024
  2. Study start26 Mar 2024
  3. Primary completion16 Apr 2024
  4. Study completion15 May 2024

Resources

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
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06310304
Sponsor's protocol ID
INCB18424-153
Status last verified
Jun 2024
First submitted
7 Mar 2024
Last updated
5 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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 5 Jun 2024. 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 22). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06310304.

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 5 Jun 2024.

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