Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02996019
Other study ID # GX29504
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 7, 2016
Est. completion date April 9, 2018

Study information

Verified date November 2018
Source Genentech, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Etrolizumab
Etrolizumab will be administered at a dose of 105 milligrams (mg).
Device:
Auto-Injector (AI)
The pre-filled AI will be used to administer etrolizumab.
Prefilled Syringe With Needle Safety Device (PFS-NSD)
The PFS-NSD will be used to administer etrolizumab.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT05029518 - 3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability Phase 1
Completed NCT05001152 - Taste Assessment of Ozanimod Phase 1
Completed NCT04493255 - A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants Phase 1
Completed NCT03457649 - IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers Phase 1
Completed NCT00995891 - Collection of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies
Completed NCT05043766 - Evaluation of Oral PF614 Relative to OxyContin Phase 1
Completed NCT05050318 - Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively Phase 4
Completed NCT04466748 - A Multiple Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects Phase 1
Completed NCT00746733 - Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC Phase 1
Recruiting NCT05929651 - Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy Phase 4
Completed NCT05954039 - Evaluation of the Efficacy of a Dietary Supplement on Hair Loss and Hair Aspect N/A
Completed NCT05045716 - A Study of Subcutaneous Lecanemab in Healthy Participants Phase 1
Active, not recruiting NCT02747927 - Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children Phase 3
Completed NCT05533801 - A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants Phase 1
Not yet recruiting NCT03931369 - Adaptation of Thirst to a Single Administration of Tolvaptan (TOLVATHIRST) Phase 2
Completed NCT03279146 - A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects Phase 1
Completed NCT06027437 - A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants Phase 1
Recruiting NCT05619874 - Effects of Two Virtual HIFCT Programs in Adults With Abdominal Obesity N/A
Completed NCT05553418 - Investigational On-body Injector Clinical Study N/A
Completed NCT04092712 - Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers Phase 1