Healthy Volunteers Clinical Trial
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
Verified date | November 2018 |
Source | Genentech, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 180 |
Est. completion date | April 9, 2018 |
Est. primary completion date | April 9, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Covance Research Unit - Dallas | Dallas | Texas |
United States | Covance Research Unit - Daytona | Daytona Beach | Florida |
United States | Covance Clinical Research Unit Inc.; Covance Gfi Research | Evansville | Indiana |
United States | Covance Clinical Research Unit, Inc | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Genentech, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Part 1: Cmax of Etrolizumab | Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71) | ||
Primary | Part 1: AUClast of Etrolizumab | Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71) | ||
Primary | Part 1: AUC0-inf of Etrolizumab | Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71) | ||
Primary | Part 1: Ratio of AUClast to AUC0-inf (AUCR) of Etrolizumab | Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71) | ||
Primary | Part 2: Cmax of Etrolizumab | Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71) | ||
Primary | Part 2: AUClast of Etrolizumab | Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71) | ||
Primary | Part 2: AUC0-inf of Etrolizumab | Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71) | ||
Secondary | Part 1: Time to Maximum Observed Concentration (tmax) of Etrolizumab | Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71) | ||
Secondary | Part 2: tmax of Etrolizumab | Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71) | ||
Secondary | Part 1: Apparent Terminal Elimination Half-Life (t1/2) of Etrolizumab | Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71) | ||
Secondary | Part 2: t1/2 of Etrolizumab | Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71) | ||
Secondary | Part 2: AUCR of Etrolizumab | Predose (0 hours) and 6 hours postdose on Day 1, on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, and at end of study (Day 71) or early discontinuation (up to Day 71) | ||
Secondary | Percentage of Participants With Adverse Events | Part 1 and 2: Baseline up to Day 71 | ||
Secondary | Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Etrolizumab | Part 1 and 2: Baseline up to Day 71 |
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