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

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ClinicalTrials.gov Identifier: NCT04149678
Recruitment Status : Recruiting
First Posted : November 4, 2019
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Ozanimod Drug: Cyclosporine Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Parallel-group, Open-label Study to Evaluate the Effect of Cyclosporine on the Single-dose Pharmacokinetics of Ozanimod and Major Active Metabolites in Healthy Adult Subjects
Actual Study Start Date : October 4, 2019
Estimated Primary Completion Date : November 13, 2019
Estimated Study Completion Date : December 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Group A - Ozanimod
Subjects will receive a single oral dose of ozanimod 0.46 mg
Drug: Ozanimod
Ozanimod

Experimental: Treatment Group B - Ozanimod plus Cyclosporine
Subjects will receive a single oral dose of ozanimod 0.46 mg plus a single oral dose of cyclosporine 600 mg
Drug: Ozanimod
Ozanimod

Drug: Cyclosporine
Cyclosporine




Primary Outcome Measures :
  1. Pharmacokinetic - Cmax [ Time Frame: Up to approximately 15 days ]
    Maximum observed plasma concentration

  2. Pharmacokinetic - AUC∞ [ Time Frame: Up to approximately 15 days ]
    Area under the concentration-time curve from time 0 to infinity

  3. Pharmacokinetic - AUClast [ Time Frame: Up to approximately 15 days ]
    Area under the concentration-time curve from time 0 to time of last quantifiable concentration


Secondary Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: From enrollment until 60 days after ozanimod dosing ]
    Number of participants with adverse event

  2. Pharmacokinetic - Tmax [ Time Frame: Up to approximately 15 days ]
    Time to Cmax

  3. Pharmacokinetic - CL/F [ Time Frame: Up to approximately 15 days ]
    Apparent oral clearance

  4. Pharmacokinetic - Vz/F [ Time Frame: Up to approximately 15 days ]
    Apparent volume of distribution during terminal phase after oral administration

  5. Pharmacokinetic - t1/2 [ Time Frame: Up to approximately 15 days ]
    Terminal elimination half-life



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

  1. 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).
  2. 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.
  3. 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.
  4. 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).
  5. 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.
  6. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
  7. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

  1. Subject with a seated blood pressure outside 90 to 140 mmHg systolic or 50 to 90 mmHg diastolic at Screening or Day -1.
  2. Subject with a seated pulse rate outside 55 to 90 beats per minute (bpm) at Screening or Day -1.
  3. 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.
  4. Subject has any condition that confounds the ability to interpret data from the study.
  5. Subject has a history of alcoholism, drug abuse, or addiction within 24 months prior to Screening.
  6. Subject has a positive serum test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
  7. 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.
  8. Subject has a positive urine drug test including cotinine at Screening or Day -1.
  9. Subject has a positive alcohol urine or breath test at Screening or Day -1.
  10. 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.
  11. 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.
  12. Subject has consumed pomelo-variety citrus fruits or juice (including pomelo, grapefruit, Seville oranges) within 7 days prior to the first dose of IP.
  13. 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.
  14. Subject has ingested alcohol within 7 days prior to the first dose of IP.
  15. Subject fails or is unwilling to abstain from strenuous physical activities for at least 24 hours prior to the first dose of IP.
  16. Subject has poor peripheral venous access.
  17. Subject has donated greater than 400 mL of blood within 60 days prior to Day 1.
  18. Subject has history of hypersensitivity or allergic reaction to sphingosine 1-phosphate (S1P) receptor modulators or cyclosporine.
  19. Subject with history of any medical condition or medical history that, in the opinion of the investigator, might confound the results of the study or jeopardize the safety or welfare of the subject.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04149678


Contacts
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Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
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United States, Texas
ICON Early Phase Services, LLC Recruiting
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Jonathan Tran, Pharm.D Celgene

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT04149678     History of Changes
Other Study ID Numbers: RPC-1063-CP-001
U1111-1239-1156 ( Other Identifier: WHO )
First Posted: November 4, 2019    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene:
Healthy Subjects
Ozanimod
Cyclosporine
Additional relevant MeSH terms:
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Cyclosporine
Cyclosporins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors