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

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Incyte Corporation
Study ID
NCT06555081
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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

Key Dates

Start date
Sep 25, 2024
Status verified
Feb 2025
Primary completion
Oct 25, 2024
Completion
Nov 7, 2024

Study Design

Enrollment
168 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Period 1: Dose Treatment A
    Ruxolitinib IR will be administered at protocol defined dose.
  • Experimental: Period 1: Dose Treatment B
    Ruxolitinib XR will be administered at protocol defined dose.
  • Experimental: Period 2: Dose Treatment A
    Ruxolitinib IR will be administered at protocol defined dose.
  • Experimental: Period 2: Dose Treatment B
    Ruxolitinib XR will be administered at protocol defined dose.

Primary Outcome Measure

INCB018424 pharmacokinetic (PK) in Plasma [ Time Frame: Up to Day 16 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Celerion Clinical Research UnitTempeArizona85283-

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By research site
Celerion Clinical Research Unit· Tempe, AZ

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