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NCT01898884 · ClinicalTrials.gov registry record · Phase 1

Safety and Pharmacology Study of VP 20629 in Adults With Friedreich's Ataxia

A Phase 1 study of Friedreich's Ataxia, sponsored by Shire.

Completed
Registry status
Phase 1
Development phase
46
Enrollment target
5
Study locations

NCT01898884 is a Phase 1 study of Friedreich's Ataxia that has completed, run by Shire. The registered enrollment target is 46 participants, below the 71-participant average among 5 other Friedreich's Ataxia trials with a reported enrollment target (35% lower). The trial reports 5 study locations across 5 states.

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The verdict

NCT01898884, a Phase 1 study of Friedreich's Ataxia, has completed, sponsored by Shire.

COMPLETED
Registry status
Phase 1
Development phase
46 participants
Enrollment target
5
Study locations

Study Summary

The objectives of the study are: * To evaluate the safety and tolerability of single and multiple oral doses of VP 20629 in subjects with Friedreich's ataxia (FA). \[Primary\] * To characterize the pharmacokinetics of VP 20629 by investigation of the plasma concentration-time profile following single and multiple oral doses in subjects with FA. \[Secondary\] * To investigate the pharmacodynamic effects of VP 20629 on plasma 8-isoprostane and malondialdehyde and urinary 8-hydroxydeoxyguanosine concentrations following multiple oral doses in subjects with FA. \[Exploratory\]

Conditions Studied

Friedreich's Ataxia

Interventions

  • DRUG Placebo
  • DRUG VP 20629

Study Locations (5)

California

  • UCLA Medical Center - Los Angeles

Florida

  • University of South Florida - Tampa

Georgia

  • Emory University - Atlanta

Iowa

  • University of Iowa Children's Hospital - Iowa City

Pennsylvania

  • Children's Hospital of Philadelphia - Philadelphia

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2013-08-13
Est. Completion 2015-06-18
Phase Phase 1

Sponsor

Shire

245 total trials

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What the Registry Record Tells You About NCT01898884

The ClinicalTrials.gov registry entry for NCT01898884 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 71-participant average among 5 other Friedreich's Ataxia trials with a reported enrollment target (35% lower). The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Friedreich's Ataxia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01898884 reports 5 study locations spanning 5 distinct geographic areas - top geographies include California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT01898884 about?

NCT01898884 is a clinical study titled "Safety and Pharmacology Study of VP 20629 in Adults With Friedreich's Ataxia". The objectives of the study are: * To evaluate the safety and tolerability of single and multiple oral doses of VP 20629 in subjects with Friedreich's ataxia (FA). \[Primary\] * To characterize the pharmacokinetics of VP 20629 by investigation of the plasma concentration-time profile following sing...

What is the current status of trial NCT01898884?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2013-08-13. Estimated completion is 2015-06-18.

What conditions does trial NCT01898884 study?

This clinical trial studies the following conditions: Friedreich's Ataxia.

What interventions are being tested in trial NCT01898884?

The interventions under investigation include: Placebo (DRUG), VP 20629 (DRUG).

Who is sponsoring clinical trial NCT01898884?

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

Where is trial NCT01898884 being conducted?

This trial has 5 study locations across California, Florida, Georgia, Iowa, Pennsylvania. 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.