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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: Completed Phase 1 study of Healthy Volunteers and Pharmacokinetics of ASP015K, sponsored by Astellas Pharma Global Development.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Interventions

  • DRUG ASP015K ER
  • DRUG ASP015K IR

Study Locations (1)

Maryland

  • Parexel International - Baltimore

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2012-06
Est. Completion 2012-07
Phase Phase 1
Astellas Pharma Global Development

168 total trials

What the finished NCT01686217 record still lists

NCT01686217 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (94% lower).

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 a single indexed study location in 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.

Similar trials for Healthy Volunteers

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 NCT01686217's enrollment target sits among peer trials

30 187th of 283 higher than 87 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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Source: ClinicalTrials.gov NCT01686217, the US trial registry maintained by the National Library of Medicine. NCT01686217 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.