Determine PK Profiles of Ozanimod and Its' Major Metabolites in Healthy Subjects

NCT06528665 | Completed DMC FDA Drug

• 1 other identifier: OZ101A
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn how Ozanimod drug can be administered to the healthy subjects via transdermal delivery system (TDS, patch) to achieve better drug absorption and delivery than via oral capsules (Zeposia). Researchers will compare two administered routes of Ozanimod TDS and oral Zeposia in drug pharmacokinetics, tolerability and safety. Participants will either take one capsule only or wear a patch on his/her arm for 7 days, and blood samples will be collected to measure drug concentrations and local skin reactions will be also observed.

Conditions

Multiple Sclerosis; Ulcerative Colitis

Keywords

Ozanimod; Transdermal Delivery system; Pharmacokinetics

Outcome Measures

Primary Outcomes (7)

• Plasma Pharmacokinetic- AUC 0-t (Ozanimod, CC112273, CC1084037)

  area under the concentration-time curve from time-zero to the time of the last quantifiable concentration

  15 days

• Plasma Pharmacokinetic- AUC 0-∞ (Ozanimod, CC112273, CC1084037)

  area under the concentration-time curve from time-zero to infinity

  15 days

• Plasma Pharmacokinetic- Cmax (Ozanimod, CC112273, CC1084037)

  Peak concentration within the dosing interval

  15 days

• Plasma Pharmacokinetic- Tmax (Ozanimod, CC112273, CC1084037)

  Time to peak concentration (Cmax)

  15 days

• Plasma Pharmacokinetic- T 1/2 (Ozanimod, CC112273, CC1084037)

  Terminal elimination half-life

  15 days

• Plasma Pharmacokinetic- MTR(Ozanimod, CC112273, CC1084037)

  Mean residence time

  15 days

• Plasma Pharmacokinetic-Lambda z(λz) (Ozanimod, CC112273, CC1084037)

  Terminal elimination rate constant

  15 days

Study Arms (1)

4 groups subjects will be recruited. Each group will be composed of 6 subjects, sex ratio 1:1

Group1, 2,3 will be administered with 3 different patches (TDS) once for a week, respectively; Group 4 will be oral administered with one capsule (0.92 mg) only.

Drug: ZEPOSIA® indicated for the treatment of: Relapsing forms of multiple sclerosis, and active ulcerative colitis in adults

Interventions

ZEPOSIA® indicated for the treatment of: Relapsing forms of multiple sclerosis, and active ulcerative colitis in adults DRUG

ZEPOSIA® * Titration is required for treatment initiation. * The recommended maintenance dosage is 0.92 mg orally once daily. * If a dose is missed within the first 2 weeks of treatment, reinitiate with the titration regimen. If a dose is missed after the first 2 weeks of treatment, continue treatment as planned.

4 groups subjects will be recruited. Each group will be composed of 6 subjects, sex ratio 1:1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Biological sex
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Local subjects participate in the Hospital Ampang, Malaysia

You may qualify if:

• Subject age between 18 to 55 years old.
• Subject body weight ≤ 120 kg, with a BMI within 18-30 kg/m2.
• Subject is able to complete the clinical study including the follow-up.
• Subject is capable of providing written informed consent.

You may not qualify if:

• Breastfeeding female.
• Pregnancy test positive female.
• At rest systolic blood pressure outside 90-140 mmHg or diastolic blood pressure outside 50-90 mmHg.
• At rest sinus bradycardia defined as symptomatic heart rate \< 50 bpm, or asymptomatic heart rate \< 45 bpm; and sinus tachycardia defined as heart rate \> 100 bpm.
• Clinically significant ECG abnormalities or Participant with history or presence of second-degree atrioventricular (AV) block Type II or third-degree AV block or sick sinus syndrome unless the patient has a functioning pacemaker.
• QTc \> 450 ms for male and \> 460 ms for female.
• A history of allergies, or any significant adverse reactions, to any medications, unless the clinician considers that they are not clinically significant.
• Clinically significant medical history of eyes, ears, nose, throat, respiratory, cardiovascular, gastrointestinal, genitourinary, neurological, haematopoietic, lymphatic, endocrine, metabolic, dermatological, musculoskeletal, psychological, family history or surgical history.
• Family history of sudden cardiac death.
• Clinically significant physical examination finding.
• Clinically significant laboratory abnormalities.
• Haemoglobin \< 12.0 g/dL for male and \< 11.0 g/dL for female at screening.
• Total bilirubin \> 1.25 x upper limit of normal (unless it is an isolated elevation where the direct bilirubin is ≤ 35% of total), ALT/AST \> 1.5 x upper limit of normal, or CK \> 2 x upper limit of normal.
• Hepatitis B, Hepatitis C or HIV positive.
• Urine DOA test positive.

Sponsors & Collaborators

• Corium Innovations, Inc.: lead

Study Sites (1)

Hospital Ampang

Ampang, Selangor, 68000, Malaysia

Location

Related Publications (1)

• Tran JQ, Zhang P, Ghosh A, Liu L, Syto M, Wang X, Palmisano M. Single-Dose Pharmacokinetics of Ozanimod and its Major Active Metabolites Alone and in Combination with Gemfibrozil, Itraconazole, or Rifampin in Healthy Subjects: A Randomized, Parallel-Group, Open-Label Study. Adv Ther. 2020 Oct;37(10):4381-4395. doi: 10.1007/s12325-020-01473-0. Epub 2020 Aug 28.

  PMID: 32857315 RESULT

MeSH Terms

Conditions

Multiple Sclerosis; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Damenthi Nair, MD

  Hospital Ampang, 68000 Ampang, Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 30, 2024
• Study Start: February 10, 2025
• Primary Completion: March 16, 2025
• Study Completion: April 16, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)