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NCT01484964 · ClinicalTrials.gov registry record · Phase 1

A Single Oral Dose Study to Compare the Bioavailability Between Two Different Tablet Formulations and Assess if There is a Food Effect With the New Formulation

A Phase 1 study of Healthy Subjects and Pharmacokinetics of ASP015K, sponsored by Astellas Pharma.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target
1
Study location

NCT01484964 is a Phase 1 study of Healthy Subjects and Pharmacokinetics of ASP015K that has completed, run by Astellas Pharma. The registered enrollment target is 24 participants, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01484964, a Phase 1 study of Healthy Subjects and Pharmacokinetics of ASP015K, has completed, sponsored by Astellas Pharma.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to determine the bioavailability and pharmacokinetics between two different formulations of ASP015K tablets and determine the food effect on the absorption of the new formulation.

Interventions

  • DRUG ASP015K

Study Locations (1)

California

  • PAREXEL - Glendale

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2011-09
Est. Completion 2011-10
Phase Phase 1

Sponsor

Astellas Pharma

165 total trials

What the Registry Record Tells You About NCT01484964

The ClinicalTrials.gov registry entry for NCT01484964 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (81% lower). The listed sponsor is Astellas Pharma, which has 165 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Healthy Subjects appearing as the primary indexed condition, and to 1 intervention - of which ASP015K is the first listed.

NCT01484964 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT01484964 about?

NCT01484964 is a clinical study titled "A Single Oral Dose Study to Compare the Bioavailability Between Two Different Tablet Formulations and Assess if There is a Food Effect With the New Formulation". The purpose of this study is to determine the bioavailability and pharmacokinetics between two different formulations of ASP015K tablets and determine the food effect on the absorption of the new formulation.

What is the current status of trial NCT01484964?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2011-09. Estimated completion is 2011-10.

What conditions does trial NCT01484964 study?

This clinical trial studies the following conditions: Healthy Subjects, Pharmacokinetics of ASP015K, Bioavailability of ASP015K.

What interventions are being tested in trial NCT01484964?

The interventions under investigation include: ASP015K (DRUG).

Who is sponsoring clinical trial NCT01484964?

This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01484964 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.