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NCT01835561 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate Pharmacokinetics of Pomalidomide in Hepatically Impaired Males
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT01835561 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 32 participants.
The verdict
NCT01835561, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
This study is for research purposes only and will not treat any disease or condition you may have. The study is an open label and single dose study; open label means that you, the study doctor and study staff will know which study drug you are taking. The purpose of this research study is to compare drug levels in the body of people with liver disease to drug levels in healthy people with a normal liver. In addition, the safety of the study drug will be studied. Information about any side effects (discomfort or decline in health) that may happen will be collected. The study drug will be given by mouth to subjects with liver disease and to healthy subjects. In the body, drugs are normally removed by the liver with a smaller amount being removed by the kidneys. When the liver is not working as well as it should, the body may not be able to remove drugs from the body quickly. The information from this study will be used to decide if the drug is safe in subjects with liver disease or if a lower dose of the study drug would be safer.
Interventions
- DRUG Pomalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2013-03-01 |
| Est. Completion | 2014-08-21 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01835561
The ClinicalTrials.gov registry entry for NCT01835561 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Pomalidomide is the first listed.
NCT01835561 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01835561 about?
NCT01835561 is a clinical study titled "Study to Evaluate Pharmacokinetics of Pomalidomide in Hepatically Impaired Males". This study is for research purposes only and will not treat any disease or condition you may have. The study is an open label and single dose study; open label means that you, the study doctor and study staff will know which study drug you are taking. The purpose of this research study is to compar...
What is the current status of trial NCT01835561?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2013-03-01. Estimated completion is 2014-08-21.
What interventions are being tested in trial NCT01835561?
The interventions under investigation include: Pomalidomide (DRUG).
Who is sponsoring clinical trial NCT01835561?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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