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NCT02045264 · ClinicalTrials.gov registry record · Phase 1
Open-label, Single-arm Study to Assess the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of Icatibant in Healthy Japanese Volunteers
A Phase 1 study, sponsored by Shire.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT02045264: Completed Phase 1 study, sponsored by Shire.
NCT02045264 is a Phase 1 study that has completed, run by Shire. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02045264, a Phase 1 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This is a single-dose study to evaluate the pharmacokinetics, safety, and tolerability of icatibant administered to adult Japanese subjects.
Primary Outcome
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Interventions
- DRUG Icatibant (30 mg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2014-02-21 |
| Est. Completion | 2014-02-27 |
| Phase | Phase 1 |
What the finished NCT02045264 record still lists
NCT02045264 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Icatibant (30 mg) is the first listed.
NCT02045264 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02045264 about?
NCT02045264 is a clinical study titled "Open-label, Single-arm Study to Assess the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of Icatibant in Healthy Japanese Volunteers". This is a single-dose study to evaluate the pharmacokinetics, safety, and tolerability of icatibant administered to adult Japanese subjects.
What is the current status of trial NCT02045264?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2014-02-21. Estimated completion is 2014-02-27.
What interventions are being tested in trial NCT02045264?
The interventions under investigation include: Icatibant (30 mg) (DRUG).
Who is sponsoring clinical trial NCT02045264?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02045264's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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