Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02996019 · ClinicalTrials.gov registry record · Phase 1
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)
A Phase 1 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 180
- Enrollment target
NCT02996019 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 180 participants.
The verdict
NCT02996019, a Phase 1 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 180 participants
- Enrollment target
Study 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.
Interventions
- DRUG Etrolizumab
- DEVICE Auto-Injector (AI)
- DEVICE Prefilled Syringe With Needle Safety Device (PFS-NSD)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2016-12-07 |
| Est. Completion | 2018-04-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02996019
The ClinicalTrials.gov registry entry for NCT02996019 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Etrolizumab is the first listed.
NCT02996019 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02996019 about?
NCT02996019 is a clinical study titled "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)". 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 m...
What is the current status of trial NCT02996019?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 180 participants. The study started on 2016-12-07. Estimated completion is 2018-04-09.
What interventions are being tested in trial NCT02996019?
The interventions under investigation include: Etrolizumab (DRUG), Auto-Injector (AI) (DEVICE), Prefilled Syringe With Needle Safety Device (PFS-NSD) (DEVICE).
Who is sponsoring clinical trial NCT02996019?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.