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NCT03097016 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Pharmacokinetics of CC-122 in Subjects With Mild, Moderate, and Severe Renal Impairment
A Phase 1 study of Renal Insufficiency, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 2
- Study locations
NCT03097016: Completed Phase 1 study of Renal Insufficiency, sponsored by Celgene.
NCT03097016 is a Phase 1 study of Renal Insufficiency that has completed, run by Celgene. The registered enrollment target is 48 participants, below the 99-participant average among 22 other Renal Insufficiency trials with a reported enrollment target (52% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03097016, a Phase 1 study of Renal Insufficiency, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 2
- Study locations
Study Summary
Multi-center, open-label, single-dose study to assess the PK of a single oral dose of 3 mg CC-122 in subjects with mild, moderate, and severe renal impairment as compared to sex, age (± 15 years), and weight (± 20%) matched control subjects with normal renal function.
Primary Outcome
Time to Observed maximum serum concentration (Cmax)
Conditions Studied
Interventions
- DRUG CC-122
Study Locations (2)
Colorado
- DaVita Clinical Research - Lakewood
Minnesota
- DaVita Clinical Research - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2017-03-30 |
| Est. Completion | 2017-12-23 |
| Phase | Phase 1 |
What the finished NCT03097016 record still lists
NCT03097016 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 99-participant average among 22 other Renal Insufficiency trials with a reported enrollment target (52% lower).
The record links to 1 condition, with Renal Insufficiency appearing as the primary indexed condition, and to 1 intervention - of which CC-122 is the first listed.
NCT03097016 reports a single indexed study location in Colorado, Minnesota.
Frequently Asked Questions
What is clinical trial NCT03097016 about?
NCT03097016 is a clinical study titled "A Study to Assess the Pharmacokinetics of CC-122 in Subjects With Mild, Moderate, and Severe Renal Impairment". Multi-center, open-label, single-dose study to assess the PK of a single oral dose of 3 mg CC-122 in subjects with mild, moderate, and severe renal impairment as compared to sex, age (± 15 years), and weight (± 20%) matched control subjects with normal renal function.
What is the current status of trial NCT03097016?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2017-03-30. Estimated completion is 2017-12-23.
What conditions does trial NCT03097016 study?
This clinical trial studies the following conditions: Renal Insufficiency.
What interventions are being tested in trial NCT03097016?
The interventions under investigation include: CC-122 (DRUG).
Who is sponsoring clinical trial NCT03097016?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03097016 being conducted?
This trial has 2 study locations across Colorado, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03097016's enrollment target sits among peer trials
48 6th of 22 higher than 17 of 22 other Renal Insufficiency trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Renal Insufficiency 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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