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NCT01759394 · ClinicalTrials.gov registry record · Phase 1
A Open-label, Three-period, Partial-replicate Design Study to Evaluate the Inter- and Intrasubject Variability of the Avatrombopag To-be-marketed Formulation Administered as Single Doses of 40 mg to Healthy Subjects Receiving a Low-fat Meal
A Phase 1 study of Healthy Volunteers, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT01759394: Completed Phase 1 study of Healthy Volunteers, sponsored by Eisai.
NCT01759394 is a Phase 1 study of Healthy Volunteers that has completed, run by Eisai. The registered enrollment target is 36 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01759394, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
A Randomized, Open-label, Three-period, Partial-replicate Design Study to Evaluate the Inter- and Intrasubject variability of the Avatrombopag To-be-marketed Formulation Administered as Single Doses of 40 mg (all doses are expressed as avatrombopag, the amount of free base) to healthy subjects Receiving a low-fat Meal.
Primary Outcome
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Conditions Studied
Interventions
- DRUG Avatrombopag maleate 40 mg
Study Locations (1)
Arizona
- Celerion - Tempe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2012-10 |
| Est. Completion | 2013-03 |
| Phase | Phase 1 |
What the finished NCT01759394 record still lists
NCT01759394 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention - of which Avatrombopag maleate 40 mg is the first listed.
NCT01759394 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT01759394 about?
NCT01759394 is a clinical study titled "A Open-label, Three-period, Partial-replicate Design Study to Evaluate the Inter- and Intrasubject Variability of the Avatrombopag To-be-marketed Formulation Administered as Single Doses of 40 mg to Healthy Subjects Receiving a Low-fat Meal". A Randomized, Open-label, Three-period, Partial-replicate Design Study to Evaluate the Inter- and Intrasubject variability of the Avatrombopag To-be-marketed Formulation Administered as Single Doses of 40 mg (all doses are expressed as avatrombopag, the amount of free base) to healthy subjects Recei...
What is the current status of trial NCT01759394?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2012-10. Estimated completion is 2013-03.
What conditions does trial NCT01759394 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT01759394?
The interventions under investigation include: Avatrombopag maleate 40 mg (DRUG).
Who is sponsoring clinical trial NCT01759394?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01759394 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01759394's enrollment target sits among peer trials
36 166th of 283 higher than 115 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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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