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NCT01318265 · ClinicalTrials.gov registry record · Phase 1

Effect of Ketoconazole on Regorafenib (BAY73-4506) Pharmacokinetics

A Phase 1 study of Pharmacokinetics, sponsored by Bayer.

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

NCT01318265 is a Phase 1 study of Pharmacokinetics that has completed, run by Bayer. The registered enrollment target is 24 participants, below the 61-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01318265, a Phase 1 study of Pharmacokinetics, has completed, sponsored by Bayer.

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

Study Summary

The purpose of this study is to estimate the effect of multiple doses of ketoconazole on the pharmacokinetics of a single dose of BAY73-4506 in healthy male volunteers.

Conditions Studied

Interventions

  • DRUG Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazole

Study Locations (1)

Massachusetts

  • - Brighton

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2011-03
Est. Completion 2011-07
Phase Phase 1

Sponsor

Bayer

591 total trials

What the Registry Record Tells You About NCT01318265

The ClinicalTrials.gov registry entry for NCT01318265 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 61-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (61% lower). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pharmacokinetics appearing as the primary indexed condition, and to 1 intervention - of which Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazole is the first listed.

NCT01318265 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT01318265 about?

NCT01318265 is a clinical study titled "Effect of Ketoconazole on Regorafenib (BAY73-4506) Pharmacokinetics". The purpose of this study is to estimate the effect of multiple doses of ketoconazole on the pharmacokinetics of a single dose of BAY73-4506 in healthy male volunteers.

What is the current status of trial NCT01318265?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2011-03. Estimated completion is 2011-07.

What conditions does trial NCT01318265 study?

This clinical trial studies the following conditions: Pharmacokinetics.

What interventions are being tested in trial NCT01318265?

The interventions under investigation include: Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazole (DRUG).

Who is sponsoring clinical trial NCT01318265?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01318265 being conducted?

This trial has 1 study location across Massachusetts. 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

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