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NCT01686217 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study to Compare 3 Different Strengths of an Extended Release Formulation of ASP015K to an Immediate Release Formulation of ASP015K
A Phase 1 study of Healthy Volunteers and Pharmacokinetics of ASP015K, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT01686217 is a Phase 1 study of Healthy Volunteers and Pharmacokinetics of ASP015K that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 30 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01686217, a Phase 1 study of Healthy Volunteers and Pharmacokinetics of ASP015K, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to compare the pharmacokinetics (PK) profiles of three different strengths of ASP015K extended release formulation and an immediate release formulation and to evaluate food effect on extended release strengths in healthy volunteers.
Conditions Studied
Interventions
- DRUG ASP015K ER
- DRUG ASP015K IR
Study Locations (1)
Maryland
- Parexel International - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-06 |
| Est. Completion | 2012-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01686217
The ClinicalTrials.gov registry entry for NCT01686217 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (94% lower). The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which ASP015K ER is the first listed.
NCT01686217 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT01686217 about?
NCT01686217 is a clinical study titled "A Phase I Study to Compare 3 Different Strengths of an Extended Release Formulation of ASP015K to an Immediate Release Formulation of ASP015K". The purpose of this study is to compare the pharmacokinetics (PK) profiles of three different strengths of ASP015K extended release formulation and an immediate release formulation and to evaluate food effect on extended release strengths in healthy volunteers.
What is the current status of trial NCT01686217?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2012-06. Estimated completion is 2012-07.
What conditions does trial NCT01686217 study?
This clinical trial studies the following conditions: Healthy Volunteers, Pharmacokinetics of ASP015K, Food Effect.
What interventions are being tested in trial NCT01686217?
The interventions under investigation include: ASP015K ER (DRUG), ASP015K IR (DRUG).
Who is sponsoring clinical trial NCT01686217?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01686217 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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