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NCT01866007 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Pharmacokinetic Comparability of Guselkumab (CNTO1959) When Delivered by 2 Different Devices and as 2 Formulations in Healthy Participants
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 141
- Enrollment target
NCT01866007 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 141 participants.
The verdict
NCT01866007, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 141 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the pharmacokinetic (what the body does to the medication) comparability of guselkumab in lyophilized and liquid formulations. Also to evaluate pharmacokinetic comparability of liquid formulation of guselkumab when delivered as prefilled syringe with UltraSafe Passive Delivery System \[PFS-U\] or with a prefilled syringe facilitated injection device \[PFS FID\]) following a single subcutaneous (SC) administration of 100 mg guselkumab in healthy participants.
Interventions
- DRUG Guselkumab (lyophilized formulation)
- DRUG Guselkumab (liquid formulation with PFS-U)
- DRUG Guselkumab (liquid formulation with PFS FID)
- DRUG Guselkumab (liquid formulation)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2013-05-09 |
| Est. Completion | 2013-10-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01866007
The ClinicalTrials.gov registry entry for NCT01866007 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 141 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Guselkumab (lyophilized formulation) is the first listed.
NCT01866007 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01866007 about?
NCT01866007 is a clinical study titled "A Study to Assess the Pharmacokinetic Comparability of Guselkumab (CNTO1959) When Delivered by 2 Different Devices and as 2 Formulations in Healthy Participants". The purpose of this study is to evaluate the pharmacokinetic (what the body does to the medication) comparability of guselkumab in lyophilized and liquid formulations. Also to evaluate pharmacokinetic comparability of liquid formulation of guselkumab when delivered as prefilled syringe with UltraSaf...
What is the current status of trial NCT01866007?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 141 participants. The study started on 2013-05-09. Estimated completion is 2013-10-09.
What interventions are being tested in trial NCT01866007?
The interventions under investigation include: Guselkumab (lyophilized formulation) (DRUG), Guselkumab (liquid formulation with PFS-U) (DRUG), Guselkumab (liquid formulation with PFS FID) (DRUG), Guselkumab (liquid formulation) (DRUG).
Who is sponsoring clinical trial NCT01866007?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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