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NCT01712828 · ClinicalTrials.gov registry record · Phase 1

Effect of P-glycoprotein Inhibition on Lenalidomide Pharmacokinetics in Healthy Males

A Phase 1 study of Healthy, sponsored by Celgene.

Completed
Registry status
Phase 1
Development phase
31
Enrollment target
1
Study location

NCT01712828 is a Phase 1 study of Healthy that has completed, run by Celgene. The registered enrollment target is 31 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01712828, a Phase 1 study of Healthy, has completed, sponsored by Celgene.

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

Study Summary

To find out if the blood level of lenalidomide can be changed when a drug that prevents p-glycoprotein (a protein naturally present in the body that helps carry substances across cell membranes that is found in many parts of the body like the intestines, liver, and kidneys) from working (called a P-gp inhibitor) when taken together with lenalidomide. The study is also trying to find out if blood level of temsirolimus can be changed when a subject takes lenalidomide together with temsirolimus.

Conditions Studied

Interventions

  • DRUG Lenalidomide
  • DRUG Diphenhydramine
  • DRUG Temsirolimus
  • DRUG Quinidine

Study Locations (1)

Texas

  • Covance Clinical Research Unit Dallas - Dallas

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2012-10-01
Est. Completion 2013-01-01
Phase Phase 1

Sponsor

Celgene

308 total trials

What the Registry Record Tells You About NCT01712828

The ClinicalTrials.gov registry entry for NCT01712828 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower). The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 4 interventions - of which Lenalidomide is the first listed.

NCT01712828 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT01712828 about?

NCT01712828 is a clinical study titled "Effect of P-glycoprotein Inhibition on Lenalidomide Pharmacokinetics in Healthy Males". To find out if the blood level of lenalidomide can be changed when a drug that prevents p-glycoprotein (a protein naturally present in the body that helps carry substances across cell membranes that is found in many parts of the body like the intestines, liver, and kidneys) from working (called a P-...

What is the current status of trial NCT01712828?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2012-10-01. Estimated completion is 2013-01-01.

What conditions does trial NCT01712828 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT01712828?

The interventions under investigation include: Lenalidomide (DRUG), Diphenhydramine (DRUG), Temsirolimus (DRUG), Quinidine (DRUG).

Who is sponsoring clinical trial NCT01712828?

This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01712828 being conducted?

This trial has 1 study location across Texas. 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.