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NCT02079545 · ClinicalTrials.gov registry record · Phase 1
Bioavailability and Pharmacokinetics Study of Sirukumab in Healthy Male Participants
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 144
- Enrollment target
NCT02079545: Completed Phase 1 study, sponsored by Janssen Research & Development.
NCT02079545 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 144 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (140% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02079545, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 144 participants
- Enrollment target
Study Summary
The purpose of the study is to assess the bioavailability (the extent to which a medication becomes available to the body) of subcutaneously (under the skin using a needle) administered sirukumab and to compare the pharmacokinetics of sirukumab administered subcutaneously using a pre-filled syringe fitted with the UltraSafe Passive™ Delivery system (PFS-U) with the SmartJect™ Autoinjector (PFS-AI) in healthy male participants.
Primary Outcome
Bioavailability will be evaluated by using the formula: AUC from time zero to infinity with extrapolation of the terminal phase of SC injection divided by AUC from time zero to infinity with extrapolation of the terminal phase of IV infusion of sirukumab and multiplied by 100.
Interventions
- DRUG Sirukumab (IV infusion)
- DRUG Sirukumab (SC injection with PFS-U)
- DRUG Sirukumab (SC injection with PFS-AI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2014-03 |
| Est. Completion | 2015-01 |
| Phase | Phase 1 |
What the finished NCT02079545 record still lists
NCT02079545 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (140% higher).
The record links to 0 conditions, and to 3 interventions - of which Sirukumab (IV infusion) is the first listed.
NCT02079545 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02079545 about?
NCT02079545 is a clinical study titled "Bioavailability and Pharmacokinetics Study of Sirukumab in Healthy Male Participants". The purpose of the study is to assess the bioavailability (the extent to which a medication becomes available to the body) of subcutaneously (under the skin using a needle) administered sirukumab and to compare the pharmacokinetics of sirukumab administered subcutaneously using a pre-filled syringe ...
What is the current status of trial NCT02079545?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 144 participants. The study started on 2014-03. Estimated completion is 2015-01.
What interventions are being tested in trial NCT02079545?
The interventions under investigation include: Sirukumab (IV infusion) (DRUG), Sirukumab (SC injection with PFS-U) (DRUG), Sirukumab (SC injection with PFS-AI) (DRUG).
Who is sponsoring clinical trial NCT02079545?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02079545's enrollment target sits among peer trials
144 394th of 2000 higher than 1,600 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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