Drug Interaction Study of the Effect on Cyclosporine on Ozanimod and Major Active Metabolites

NCT04149678 | Completed Phase 1 FDA Drug

• 2 other identifiers: RPC-1063-CP-001U1111-1239-1156
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1, randomized, parallel-group, open-label study. Forty subjects will be enrolled and will be randomized into 1 of the 2 treatment groups, with 20 subjects in each treatment group(sex will be used as a stratifying factor) as follows:

• Treatment Group A (reference): A single oral dose of ozanimod 0.46 mg
• Treatment Group B (test): A single oral dose of ozanimod 0.46 mg plus a single oral dose of cyclosporine 600 mg

Conditions

Healthy Volunteers

Keywords

Healthy Subjects; Ozanimod; Cyclosporine

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetic - Cmax

  Maximum observed plasma concentration

  Up to approximately 15 days

• Pharmacokinetic - AUC∞

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

  Up to approximately 15 days

• Pharmacokinetic - AUClast

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

  Up to approximately 15 days

Secondary Outcomes (5)

• Adverse Events (AEs)

  From enrollment until 60 days after ozanimod dosing

• Pharmacokinetic - Tmax

  Up to approximately 15 days

• Pharmacokinetic - CL/F

  Up to approximately 15 days

• Pharmacokinetic - Vz/F

  Up to approximately 15 days

• Pharmacokinetic - t1/2

  Up to approximately 15 days

Study Arms (2)

Treatment Group A - Ozanimod

EXPERIMENTAL

Subjects will receive a single oral dose of ozanimod 0.46 mg

Drug: Ozanimod

Treatment Group B - Ozanimod plus Cyclosporine

EXPERIMENTAL

Subjects will receive a single oral dose of ozanimod 0.46 mg plus a single oral dose of cyclosporine 600 mg

Drug: Ozanimod; Drug: Cyclosporine

Interventions

Ozanimod DRUG

Ozanimod

Treatment Group A - Ozanimod; Treatment Group B - Ozanimod plus Cyclosporine

Cyclosporine DRUG

Cyclosporine

Treatment Group B - Ozanimod plus Cyclosporine

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 man or non-pregnant, non-lactating woman, ≥ 18 and ≤ 55 years of age at the time of signing the informed consent form (ICF).
• Female subjects must meet at least 1 of the following criteria:
• Negative serum pregnancy test at Screening and Day -1 (females of child-bearing potential \[FCBP\] only).
• Postmenopausal (defined as 2 years after the last period and follicle-stimulating hormone \[FSH\] \> 40 IU/L).
• Received surgical sterilization (eg, bilateral tubal ligation, bilateral oophorectomy, hysterectomy) at least 6 months before Screening with medical records.
• 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 (oestrogen 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
• Sexual abstinence Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception. Female condom and male condom should not be used together.
• Subject has 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 (Screening and Day -1).
• Subject is in good health, as determined by no clinically significant findings from medical or surgical history, 12-lead ECG, physical examination, clinical laboratory tests, and vital signs.

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 IP (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 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)

ICON Early Phase Services

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Interventions

ozanimod; Cyclosporine

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Jonathan Tran, Pharm.D

  Celgene

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 4, 2019
• Study Start: October 4, 2019
• Primary Completion: November 13, 2019
• Study Completion: December 26, 2019
• Last Updated: August 24, 2020

Record last verified: 2020-08

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)