This is a Phase 1, open-label, randomized, parallel-group, single-dose study. Approximately 56 participants will be enrolled and randomized into 1 of the 2 treatment groups, with 28 participants in each treatment group as follows: * Treatment Group A (reference): Current ozanimod capsule formulation * Treatment Group B (test): Ozanimod granule formulation participants will be screened within 28 days prior to dosing. Eligible participants will be admitted to the clinical research unit one day before dosing (Day -1) and will be domiciled until Day 15. On Day 1, a single oral dose of 0.92 mg of ozanimod will be administered using either the current capsule formulation (Group A) or the granule formulation (Group B). Participants will be contacted by telephone 30 ± 5 days after dosing for a follow up safety assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
56
Ozanimod capsule formulation of 0.92mg
Ozanimod, granule formulation of 0.92mg
PPD Phase 1 Clinic
Austin, Texas, United States
Pharmacokinetic- Cmax (Ozanimod, CC112273, CC1084037)
Maximum observed plasma concentration
Time frame: Up to 14 days
Pharmacokinetic- AUC∞(Ozanimod)
Area under the concentration-time curve from time 0 to infinity
Time frame: Up to 14 days
Pharmacokinetic- AUClast (CC112273 and CC1084037)
Area under the concentration-time curve from time 0 to last quantifiable concentration
Time frame: Up to 14 days
Adverse Events (AEs)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
Time frame: From enrollment until at least 30 days after last dose of IP
Pharmacokinetic- AUClast (Ozanimod)
Area under the concentration-time curve from time 0 to last quantifiable concentration
Time frame: Up to 14 days
Pharmacokinetic- Tmax (Ozanimod, CC112273, and CC1084037)
Time to Cmax
Time frame: Up to 14 days
Pharmacokinetic- CL/F (Ozanimod)
Apparent oral clearance
Time frame: Up to 14 days
Pharmacokinetic- Vz/F (Ozanimod)
Apparent volume of distribution during terminal phase after oral administration
Time frame: Up to 14 days
Pharmacokinetic- t1/2 (Ozanimod, CC112273, and CC1084037)
Terminal elimination half-life
Time frame: Up to 14 days
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