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NCT01583036 · ClinicalTrials.gov registry record · Phase 1

An Open-label, Single-centre Study Evaluating the Pharmacokinetics of Digoxin Alone and When Administered at Various Doses of Ezogabine/Retigabine in Healthy Adults. The Pharmacokinetics of Ezogabine/Retigabine and the N-acetyl Metabolite of Ezogabine/Retigabine (NAMR) Will Also be Assessed

A Phase 1 study of Epilepsy, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target
1
Study location

NCT01583036 is a Phase 1 study of Epilepsy that has completed, run by GlaxoSmithKline. The registered enrollment target is 30 participants, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01583036, a Phase 1 study of Epilepsy, has completed, sponsored by GlaxoSmithKline.

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

Study Summary

An interaction study to assess the effect of the ezogabine/retigabine and the main metabolite NAMR on the pharmacokinetics of digoxin in healthy volunteers

Conditions Studied

Interventions

  • DRUG Digoxin Alone
  • DRUG Digoxin + Retigabine

Study Locations (1)

Maryland

  • GSK Investigational Site - Baltimore

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2012-01-16
Est. Completion 2012-04-17
Phase Phase 1

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT01583036

The ClinicalTrials.gov registry entry for NCT01583036 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (97% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Epilepsy appearing as the primary indexed condition, and to 2 interventions - of which Digoxin Alone is the first listed.

NCT01583036 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT01583036 about?

NCT01583036 is a clinical study titled "An Open-label, Single-centre Study Evaluating the Pharmacokinetics of Digoxin Alone and When Administered at Various Doses of Ezogabine/Retigabine in Healthy Adults. The Pharmacokinetics of Ezogabine/Retigabine and the N-acetyl Metabolite of Ezogabine/Retigabine (NAMR) Will Also be Assessed". An interaction study to assess the effect of the ezogabine/retigabine and the main metabolite NAMR on the pharmacokinetics of digoxin in healthy volunteers

What is the current status of trial NCT01583036?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2012-01-16. Estimated completion is 2012-04-17.

What conditions does trial NCT01583036 study?

This clinical trial studies the following conditions: Epilepsy.

What interventions are being tested in trial NCT01583036?

The interventions under investigation include: Digoxin Alone (DRUG), Digoxin + Retigabine (DRUG).

Who is sponsoring clinical trial NCT01583036?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01583036 being conducted?

This trial has 1 study location across Maryland. 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.