A Study to Compare Pharmacokinetics (PK) of Etrolizumab Administered Subcutaneously by a Prefilled Syringe With Needle Safety Device (PFS-NSD) or an Auto-injector (AI)

  • Healthy Volunteers
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Completed

This trial runs in
Country
  • United States
Trial Identifier:

NCT02996019 GX29504

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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      Trial Summary

      This is a randomized, 2-part, 2-arm, open-label, parallel-group, multi-center study to compare the PK of etrolizumab administered subcutaneously by an AI (test device) or a PFS-NSD (reference device) in healthy participants. The study will comprise a pilot cohort (Part 1) to estimate the geometric mean ratio (GMR) and variability of the maximum observed concentration (Cmax) and area under the concentration-time curve (AUC) to confirm or determine the sample size for the pivotal cohort (Part 2). The pivotal cohort will demonstrate exposure comparability of Cmax, AUC from Hour 0 to the last measurable concentration (AUClast), and AUC from Hour 0 to extrapolated infinite time (AUC0-inf), values for a single dose of etrolizumab administered subcutaneously either by the AI or the PFS-NSD.

      Genentech, Inc. Sponsor
      Phase 1 Phase
      NCT02996019,GX29504 Trial Identifier
      Etrolizumab, Auto-Injector (AI), Prefilled Syringe With Needle Safety Device (PFS-NSD) Treatments
      Healthy Volunteers Condition
      Official Title

      A Randomized, Open-Label, 2-Part, 2-Arm, Parallel-Group, Single-Dose, Multi-Center Study in Healthy Subjects to Investigate the Comparability of Pharmacokinetics of Etrolizumab Administered Subcutaneously by a Prefilled Syringe With Needle Safety Device or an Auto-Injector

      Eligibility Criteria

      All Gender
      ≥ 18 Years & ≤ 55 Years Age
      Accepts Healthy Volunteers Healthy Volunteers
      Inclusion Criteria
      • Within the body weight range of 60 to 100 kilograms, inclusive (for the pivotal cohort [Part 2] only)
      • Within body mass index (BMI) range 18.0 to 30.0 kilograms per square meter (kg/m^2), inclusive
      • In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), and vital signs
      • Females will be non-pregnant, non-lactating, and either postmenopausal (at least 12 months of non-therapy-induced amenorrhea)/surgically sterile (e.g., tubal ligation, hysterectomy) for at least 90 days prior to enrolment, or agree to remain abstinent/use a highly effective method of contraception for at least 24 weeks after study drug administration
      • Males will either be sterile or agree to remain abstinent/use a highly effective method of contraception for at least 24 weeks after study drug administration. Male participants will refrain from sperm donation from Check-in (Day -1) until 24 weeks following study drug administration
      Exclusion Criteria
      • Any prior treatment with etrolizumab or other anti-integrin agents (including natalizumab, vedolizumab, and efalizumab)
      • Any prior treatment with anti-mucosal addressin cell adhesion molecule 1 (anti-MAdCAM-1) agents
      • Any prior treatment with rituximab
      • Received intravenous corticosteroids within 30 days prior to Screening
      • Use of agents that deplete B or T cells (e.g., alemtuzumab, rituximab, or visilizumab) within 12 months prior to randomization
      • Any prior immunosuppressive agents (including cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil)
      • Chronic nonsteroidal anti-inflammatory drug (NSAID) use
      • Use of any prescription medications/products within 14 days prior to Check in (Day -1)
      • History of demyelinating disease
      • Neurological conditions or diseases
      • History of cancer
      • History of alcoholism or drug addiction within less than (<) 1 year prior to Screening
      • History of active or latent tuberculosis (TB), regardless of treatment history
      • History of recurrent opportunistic infections and/or history of severe disseminated viral infections
      • Positive for human immunodeficiency virus (HIV) antibody
      • Any current or recent signs or symptoms of infection
      • Pregnant or lactating
      • Hospitalized within 4 weeks prior to and during Screening
      • History of organ transplant
      • Presence of skin rash at Screening or history of other skin disorders
      • Tattoos, scars, chronic rashes, or sunburn in the area of the designated injection site

      For the latest version of this information please go to www.forpatients.roche.com

       

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