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NCT02564497 · ClinicalTrials.gov registry record · Phase 1
A Study to Compare the Pharmacokinetics of Belatacept Using Active Pharmaceutical Ingredient Manufactured by Process E Relative to Process C
A Phase 1 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 491
- Enrollment target
NCT02564497: Completed Phase 1 study, sponsored by Bristol-Myers Squibb.
NCT02564497 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 491 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (718% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02564497, a Phase 1 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 491 participants
- Enrollment target
Study Summary
The purpose of the study is to compare the Pharmacokinetics (PK) of Process E belatacept relative to Process C belatacept in Healthy subjects
Primary Outcome
(AUC\[INF\]) was derived from serum concentration versus time data and measured in nanogram hours per milliliter (ng\*h/mL). Serum samples were analyzed for belatacept by a validated enzyme-linked immunosorbent assay (ELISA)
Interventions
- BIOLOGICAL Process E Belatacept
- BIOLOGICAL Process C Belatacept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 491 participants |
| Start Date | 2015-10-02 |
| Est. Completion | 2017-01-27 |
| Phase | Phase 1 |
What the finished NCT02564497 record still lists
NCT02564497 is an interventional study that assigns participants to a tested intervention. The registered 491 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 (718% higher).
The record links to 0 conditions, and to 2 interventions - of which Process E Belatacept is the first listed.
NCT02564497 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02564497 about?
NCT02564497 is a clinical study titled "A Study to Compare the Pharmacokinetics of Belatacept Using Active Pharmaceutical Ingredient Manufactured by Process E Relative to Process C". The purpose of the study is to compare the Pharmacokinetics (PK) of Process E belatacept relative to Process C belatacept in Healthy subjects
What is the current status of trial NCT02564497?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 491 participants. The study started on 2015-10-02. Estimated completion is 2017-01-27.
What interventions are being tested in trial NCT02564497?
The interventions under investigation include: Process E Belatacept (BIOLOGICAL), Process C Belatacept (BIOLOGICAL).
Who is sponsoring clinical trial NCT02564497?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02564497's enrollment target sits among peer trials
491 47th of 2000 higher than 1,954 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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