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NCT01905553 · ClinicalTrials.gov registry record · Phase 1

The Effect of Food on the Bioavailability of a Single Dose of SSP-004184SS in Healthy Adult Subjects

A Phase 1 study, sponsored by Shire.

Completed
Registry status
Phase 1
Development phase
9
Enrollment target

NCT01905553: Completed Phase 1 study, sponsored by Shire.

NCT01905553 is a Phase 1 study that has completed, run by Shire. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01905553, a Phase 1 study, has completed, sponsored by Shire.

COMPLETED
Registry status
Phase 1
Development phase
9 participants
Enrollment target

Study Summary

To assess the effect of food on the pharmacokinetic profile of SSP-004184 compared to administration under fasted conditions.

Primary Outcome

AUCinf is the area under the plasma concentration versus time curve from time 0 to infinity. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.

Interventions

  • DRUG SSP-004184SS

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2013-08-27
Est. Completion 2013-09-24
Phase Phase 1
Shire

245 total trials

What the finished NCT01905553 record still lists

NCT01905553 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).

The record links to 0 conditions, and to 1 intervention - of which SSP-004184SS is the first listed.

NCT01905553 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01905553 about?

NCT01905553 is a clinical study titled "The Effect of Food on the Bioavailability of a Single Dose of SSP-004184SS in Healthy Adult Subjects". To assess the effect of food on the pharmacokinetic profile of SSP-004184 compared to administration under fasted conditions.

What is the current status of trial NCT01905553?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2013-08-27. Estimated completion is 2013-09-24.

What interventions are being tested in trial NCT01905553?

The interventions under investigation include: SSP-004184SS (DRUG).

Who is sponsoring clinical trial NCT01905553?

This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01905553's enrollment target sits among peer trials

9 1955th of 2000 higher than 42 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 NCT01905553, the US trial registry maintained by the National Library of Medicine. NCT01905553 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.