A Study to Evaluate the Relative Bioavailability of a Pediatric Granule Formulation of Ozanimod in Healthy Adult Subjects

NCT04528290 | Completed Phase 1 FDA Drug

• 2 other identifiers: RPC-1063-CP-003U1111-1256-5078
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

Ozanimod; RPC-1063; Pediatric Granule Formulation; Healthy Volunteer; Pharmacokinetics (PK)

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetic- Cmax (Ozanimod, CC112273, CC1084037)

  Maximum observed plasma concentration

  Up to 14 days

• Pharmacokinetic- AUC∞(Ozanimod)

  Area under the concentration-time curve from time 0 to infinity

  Up to 14 days

• Pharmacokinetic- AUClast (CC112273 and CC1084037)

  Area under the concentration-time curve from time 0 to last quantifiable concentration

  Up to 14 days

Secondary Outcomes (6)

• Adverse Events (AEs)

  From enrollment until at least 30 days after last dose of IP

• Pharmacokinetic- AUClast (Ozanimod)

  Up to 14 days

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

  Up to 14 days

• Pharmacokinetic- CL/F (Ozanimod)

  Up to 14 days

• Pharmacokinetic- Vz/F (Ozanimod)

  Up to 14 days

Study Arms (2)

Group A (reference): Current ozanimod capsule formulation

EXPERIMENTAL

Single oral dose of ozanimod 0.92 mg

Drug: Ozanimod

Group B (test): Ozanimod granule formulation

EXPERIMENTAL

Single oral dose of ozanimod 0.92 mg using Sprinkle capsule. Ozanimod Sprinkle Capsule will be opened, and the entire contents sprinkled onto a teaspoon (5 mL) of applesauce.

Drug: Ozanimod

Interventions

Ozanimod DRUG

Ozanimod capsule formulation of 0.92mg

Also known as: RPC1063

Group A (reference): Current ozanimod capsule formulation

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must satisfy the following criteria to be enrolled in the study:
• Subject is a male or female, ≥ 18 and ≤ 55 years
• Female subjects must meet at least 1 of the following criteria:
• Negative serum pregnancy test at Screening and Day -1
• Postmenopausal
• Received surgical sterilization
• Female subjects of child-bearing potential:
• Must agree to practice a highly effective method of contraception throughout the study until completion of the Follow-up phone call.
• Highly effective methods of contraception are those that alone or in combination result in a failure rate of a Pearl index of less than 1% per year when used consistently and correctly.
• Acceptable methods of birth control in this study are the following:
• Combined hormonal (estrogen and progestogen containing) contraception, which may be oral, intravaginal, or transdermal
• Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injectable, implantable
• Placement of an intrauterine device or intrauterine hormone-releasing system
• Bilateral tubal occlusion
• Vasectomized partner

You may not qualify if:

• The presence of any of the following will exclude a subject from enrollment:
• Subject with a seated blood pressure outside 90 to 140 mmHg systolic or 50 to 90 mmHg diastolic at Screening or Day -1.
• Subject with a seated pulse rate outside 55 to 90 beats per minute (bpm) at Screening or Day -1.
• Subject has a presence or history of any abnormality or illness that, in the opinion of the Investigator, may affect absorption, distribution, metabolism, or elimination of the IPs or would limit the subject's ability to participate in and complete this clinical study.
• Subject has any condition that confounds the ability to interpret data from the study.
• Subject has a history of alcoholism, drug abuse, or addiction within 24 months prior to Screening.
• Subject has a positive serum test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
• Subject has used any tobacco- or nicotine-containing products (including but not limited to cigarettes, pipes, cigars, electronic cigarettes, vape, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) or marijuana (cigarette, joint, vape, edibles, etc) within 3 months prior to the first dose of IP.
• Subject has a positive urine drug test including cotinine at Screening or Day -1.
• Subject has a positive alcohol urine or breath test at Screening or Day -1.
• Subject has received any investigational drug within 30 days or 5 times the elimination half-life (if known), whichever is longer, prior to the first dose of IP.
• Subject has used any systemic over-the-counter medication (excluding acetaminophen up to 1 g/day), dietary or herbal supplement (excluding vitamins/multivitamins) within 7 days prior to the first dose of IP. Herbal supplements including St. John's wort, naringenin, curcurmin/turmeric, passion flower, and quercetin must be discontinued at least 28 days prior to the first dose of IP.
• Subject has consumed pomelo-variety citrus fruits or juice (including pomelo, grapefruit, Seville oranges) within 7 days prior to the first dose of IP.
• Subject has used any systemic prescription medication (excluding hormonal contraceptives) within 28 days or 5 times the elimination half-life, whichever is longer, prior to the first dose of IP.
• Subject has ingested alcohol within 7 days prior to the first dose of IP.

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

PPD Phase 1 Clinic

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

ozanimod

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 27, 2020
• Study Start: October 7, 2020
• Primary Completion: May 19, 2021
• Study Completion: June 1, 2021
• Last Updated: September 20, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (1)