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NCT00984113 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of Elinogrel in Healthy Volunteers and Patients With Mild, Moderate, and Severe Renal Impairment
A Phase 1 study, sponsored by Portola Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT00984113: Clinical Trial Phase 1 study, sponsored by Portola Pharmaceuticals.
NCT00984113 is a Phase 1 study that was terminated before completion, run by Portola Pharmaceuticals. The registered enrollment target is 44 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00984113, a Phase 1 study, was terminated before completion, sponsored by Portola Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
The purpose of the study is to determine the pharmacokinetics and safety of elinogrel and its metabolite in patients with mild, moderate, and severe renal impairment compared to healthy volunteers.
Primary Outcome
The PK parameters calculated for both elinogrel and PRT060301 were: * AUC0-12h, Cmax, and Tmax on Day 1/Day 7 and T1/2, RACC \& CLR on Day 7 * For elinogrel only, CLss/F and Vss/F were also calculated
Interventions
- DRUG Elinogrel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2009-09 |
| Est. Completion | 2009-12 |
| Phase | Phase 1 |
Why NCT00984113 stopped before completion
NCT00984113 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 1 intervention - of which Elinogrel is the first listed.
NCT00984113 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00984113 about?
NCT00984113 is a clinical study titled "Pharmacokinetics of Elinogrel in Healthy Volunteers and Patients With Mild, Moderate, and Severe Renal Impairment". The purpose of the study is to determine the pharmacokinetics and safety of elinogrel and its metabolite in patients with mild, moderate, and severe renal impairment compared to healthy volunteers.
What is the current status of trial NCT00984113?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2009-09. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00984113?
The interventions under investigation include: Elinogrel (DRUG).
Who is sponsoring clinical trial NCT00984113?
This trial is sponsored by Portola Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00984113's enrollment target sits among peer trials
44 1086th of 2000 higher than 901 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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