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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: Completed Phase 1 study of Healthy, sponsored by Celgene.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Area under the plasma concentration-time curve from time zero to 24 hours post dose
Conditions Studied
Interventions
- DRUG Lenalidomide
- DRUG Diphenhydramine
- DRUG Temsirolimus
- DRUG Quinidine
Study Locations (1)
Texas
- Covance Clinical Research Unit Dallas - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2012-10-01 |
| Est. Completion | 2013-01-01 |
| Phase | Phase 1 |
What the finished NCT01712828 record still lists
NCT01712828 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01712828's enrollment target sits among peer trials
31 674th of 1090 higher than 414 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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