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NCT01476800 · ClinicalTrials.gov registry record · Phase 1

A Study to Assess Pharmacokinetic Interaction of Multiple Dose Ketoconazole on Single Dose YM178 Oral Controlled Absorption System (OCAS) in Healthy Adult Volunteers

A Phase 1 study, sponsored by Astellas Pharma.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT01476800: Completed Phase 1 study, sponsored by Astellas Pharma.

NCT01476800 is a Phase 1 study that has completed, run by Astellas Pharma. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01476800, a Phase 1 study, has completed, sponsored by Astellas Pharma.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study Summary

The purpose of this study is to assess the pharmacokinetic interaction of multiple-dose ketoconazole on single-dose YM178 OCAS and the safety and tolerability of YM178 OCAS alone and in combination with ketoconazole in healthy adult volunteers.

Interventions

  • DRUG Ketoconazole
  • DRUG YM178 OCAS

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2006-07
Est. Completion 2006-11
Phase Phase 1
Astellas Pharma

165 total trials

What the finished NCT01476800 record still lists

NCT01476800 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).

The record links to 0 conditions, and to 2 interventions - of which Ketoconazole is the first listed.

NCT01476800 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01476800 about?

NCT01476800 is a clinical study titled "A Study to Assess Pharmacokinetic Interaction of Multiple Dose Ketoconazole on Single Dose YM178 Oral Controlled Absorption System (OCAS) in Healthy Adult Volunteers". The purpose of this study is to assess the pharmacokinetic interaction of multiple-dose ketoconazole on single-dose YM178 OCAS and the safety and tolerability of YM178 OCAS alone and in combination with ketoconazole in healthy adult volunteers.

What is the current status of trial NCT01476800?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2006-07. Estimated completion is 2006-11.

What interventions are being tested in trial NCT01476800?

The interventions under investigation include: Ketoconazole (DRUG), YM178 OCAS (DRUG).

Who is sponsoring clinical trial NCT01476800?

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

How this trial's enrollment target compares

Where NCT01476800's enrollment target sits among peer trials

24 1520th of 2000 higher than 405 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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Source: ClinicalTrials.gov NCT01476800, the US trial registry maintained by the National Library of Medicine. NCT01476800 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.