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NCT01648790 · ClinicalTrials.gov registry record · Phase 1
A Study of Prasugrel in Healthy Participants
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01648790: Completed Phase 1 study, sponsored by Eli Lilly and Company.
NCT01648790 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01648790, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the amount of drug available in the body when given to healthy participants as two different formulations with or without a meal. In addition, this study will evaluate how much of the drug gets into the blood stream and how long the body takes to get rid of it. Information about any side effects that may occur will also be collected. Each participant will receive a total of five different treatments. Each treatment is given by mouth, once a day. The treatment period lasts for five consecutive days.
Primary Outcome
Cmax= maximum concentration measured from predose through 8 hours postdose. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) and the reference formulation is defined as the orally disintegrating tablet without Magnasweet® (ODT1) specific to the 5 milligrams (mg) prasugrel dosing. Pharmacokinetics will measure prasugrel's (LY640315) active metabolite.
Interventions
- DRUG Prasugrel ODT1 - Tablet
- DRUG Prasugrel ODT2 - Tablet
- DRUG Prasugrel ODT2 - Suspension
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2012-07 |
| Est. Completion | 2012-08 |
| Phase | Phase 1 |
What the finished NCT01648790 record still lists
NCT01648790 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 3 interventions - of which Prasugrel ODT1 - Tablet is the first listed.
NCT01648790 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01648790 about?
NCT01648790 is a clinical study titled "A Study of Prasugrel in Healthy Participants". The purpose of this study is to evaluate the amount of drug available in the body when given to healthy participants as two different formulations with or without a meal. In addition, this study will evaluate how much of the drug gets into the blood stream and how long the body takes to get rid of i...
What is the current status of trial NCT01648790?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2012-07. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01648790?
The interventions under investigation include: Prasugrel ODT1 - Tablet (DRUG), Prasugrel ODT2 - Tablet (DRUG), Prasugrel ODT2 - Suspension (DRUG).
Who is sponsoring clinical trial NCT01648790?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01648790's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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