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NCT01489995 · ClinicalTrials.gov registry record · Phase 1

Migalastat Food Effect Study

A Phase 1 study, sponsored by Amicus Therapeutics.

Completed
Registry status
Phase 1
Development phase
20
Enrollment target

NCT01489995: Completed Phase 1 study, sponsored by Amicus Therapeutics.

NCT01489995 is a Phase 1 study that has completed, run by Amicus Therapeutics. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01489995, a Phase 1 study, has completed, sponsored by Amicus Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target

Study Summary

A 5-period crossover study to evaluate the effect of meal type and timing on migalastat HCl pharmacokinetics in healthy male and female subjects. Subjects will be randomly assigned to 1 of 5 treatment sequences and will receive each treatment over the course of 5 weekly periods.

Primary Outcome

Cmax

Interventions

  • DRUG A (migalastat)
  • DRUG B (migalastat)
  • DRUG C (migalastat)
  • DRUG D (migalastat)
  • DRUG E (migalastat)

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2011-10
Est. Completion 2011-12
Phase Phase 1
Amicus Therapeutics

34 total trials

What the finished NCT01489995 record still lists

NCT01489995 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).

The record links to 0 conditions, and to 5 interventions - of which A (migalastat) is the first listed.

NCT01489995 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01489995 about?

NCT01489995 is a clinical study titled "Migalastat Food Effect Study". A 5-period crossover study to evaluate the effect of meal type and timing on migalastat HCl pharmacokinetics in healthy male and female subjects. Subjects will be randomly assigned to 1 of 5 treatment sequences and will receive each treatment over the course of 5 weekly periods.

What is the current status of trial NCT01489995?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2011-10. Estimated completion is 2011-12.

What interventions are being tested in trial NCT01489995?

The interventions under investigation include: A (migalastat) (DRUG), B (migalastat) (DRUG), C (migalastat) (DRUG), D (migalastat) (DRUG), E (migalastat) (DRUG).

Who is sponsoring clinical trial NCT01489995?

This trial is sponsored by Amicus Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01489995's enrollment target sits among peer trials

20 1629th of 2000 higher than 285 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 NCT01489995, the US trial registry maintained by the National Library of Medicine. NCT01489995 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.