NCT03624959

Drug-drug Interaction Study of Ozanimod With Inhibitor or Inducer of CYP2C8 and/or CYP3A

Completed Phase 1 Last updated 30 May 2019

What this trial tests

Phase 1 trial testing Ozanimod in Healthy Volunteer in 100 participants. Completed in 10 August 2018.

Timeline

20 June 2018

Primary endpoint
10 August 2018

10 August 2018

Quick facts

Lead sponsor	Celgene
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	100
Start date	20 June 2018
Primary completion	10 August 2018
Estimated completion	10 August 2018
Sites	1 location across United States

Drugs / interventions tested

• Ozanimod (OZANIMOD) — full drug profile →
• Gemfibrozil (Gemfibrozil) — full drug profile →
• Itraconazole — full drug profile →
• Rifampin — full drug profile →

Conditions studied

• Healthy Volunteer — all drugs for Healthy Volunteer →

Sponsor

Celgene — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy Volunteer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the effect of the following index inhibitors or inducers of CYP2C8 and/or CYP3A on the single-dose pharmacokinetics (PK) of ozanimod and its major active metabolite, CC112273, in healthy adult subjects: gemfibrozil (strong inhibitor of CYP2C8), rifampin (moderate inducer of CYP2C8 and strong inducer of CYP3A), and itraconazole (strong inhibitor of CYP3A).

Study Design

This is a Phase 1, randomized, parallel-group, open-label study with two parts, 1 and 2. Forty subjects will be enrolled in Part 1 and will be randomized into 1 of the 2 treatment groups, with 20 subjects in each treatment group. Sixty subjects will be enrolled in Part 2 and will be randomized into 1 of the 3 treatment groups, with 20 subjects in each treatment group. . Study parts and treatment groups are as follow:

Part 1:

* Treatment Group A (reference): A single dose of ozanimod.
* Treatment Group B (test): Gemfibrozil 600 mg twice daily (BID) on Days 1 through 17. On Day 4, a single dose of ozanimod will be coadministered with the morning dose of gemfibrozil.

Part 2:

* Treatment Group C (reference): A single dose of ozanimod.
* Treatment Group D (test): Itraconazole 200 mg once daily (QD) on Days 1 through 17. On Day 4, a single dose of ozanimod will be coadministered with itraconazole.
* Treatment Group E (test): Rifampin 600 mg QD on Days 1 through 21. On Day 8, a single dose of ozanimod will be coadministered with rifampin.

Study Population Subjects will be healthy men and non-pregnant, non-lactating women, ages 18 to 55 years, inclusive, with a body weight of at least 110 pounds (50 kg); body mass index (BMI) within the range of 18.0 to 30.0 kg/m2, inclusive.

Length of Study The study duration ranges from 43 days to 50 days.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The S1P-S1PR Axis in Neurological Disorders-Insights into Current and Future Therapeutic Perspectives.
   Lucaciu A, Brunkhorst R, Pfeilschifter JM, Pfeilschifter W, et al · · 2020 · cited 53× · PMID 32580348 · DOI 10.3390/cells9061515
2. 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.
   Tran JQ, Zhang P, Ghosh A, Liu L, et al · · 2020 · cited 20× · PMID 32857315 · DOI 10.1007/s12325-020-01473-0