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NCT02128321 · ClinicalTrials.gov registry record · Phase 1

A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Repaglinide and Caffeine

A Phase 1 study of Healthy Subjects and Pharmacokinetics of Repaglinide, sponsored by Astellas Pharma Global Development.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target
1
Study location

NCT02128321 is a Phase 1 study of Healthy Subjects and Pharmacokinetics of Repaglinide that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 24 participants, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02128321, a Phase 1 study of Healthy Subjects and Pharmacokinetics of Repaglinide, has completed, sponsored by Astellas Pharma Global Development.

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

Study Summary

The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of Repaglinide and possible metabolites after single dose administration. In addition, this study will assess the effect of multiple doses of isavuconazole on the pharmacokinetics of caffeine and possible metabolites after single dose administration. Safety and tolerability of isavuconazole alone and in combination with Repaglinide or in combination with caffeine will be assessed.

Conditions Studied

Healthy Subjects Pharmacokinetics of Repaglinide Pharmacokinetics of Caffeine

Interventions

  • DRUG Caffeine
  • DRUG Isavuconazole
  • DRUG Repaglinide

Study Locations (1)

Maryland

  • Parexel Early Phase Clinical Unit - Baltimore

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2014-01
Est. Completion 2014-02
Phase Phase 1

Sponsor

Astellas Pharma Global Development

168 total trials

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What the Registry Record Tells You About NCT02128321

The ClinicalTrials.gov registry entry for NCT02128321 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (81% lower). The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Healthy Subjects appearing as the primary indexed condition, and to 3 interventions - of which Caffeine is the first listed.

NCT02128321 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT02128321 about?

NCT02128321 is a clinical study titled "A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Repaglinide and Caffeine". The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of Repaglinide and possible metabolites after single dose administration. In addition, this study will assess the effect of multiple doses of isavuconazole on the pharmacokinetics of caffeine...

What is the current status of trial NCT02128321?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2014-01. Estimated completion is 2014-02.

What conditions does trial NCT02128321 study?

This clinical trial studies the following conditions: Healthy Subjects, Pharmacokinetics of Repaglinide, Pharmacokinetics of Caffeine.

What interventions are being tested in trial NCT02128321?

The interventions under investigation include: Caffeine (DRUG), Isavuconazole (DRUG), Repaglinide (DRUG).

Who is sponsoring clinical trial NCT02128321?

This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02128321 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

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.