Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03097016
The ClinicalTrials.gov registry entry for NCT03097016 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 99-participant average among 22 other Renal Insufficiency trials with a reported enrollment target (52% lower). The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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
Similar trials for Renal Insufficiency
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.
-
A Study of LY3537982 in Participants With Kidney Problems Compared With Participants With Normal Kidney Function
RECRUITING · Phase 1
-
A Study of Eloralintide (LY3841136) in Participants With Renal Impairment and in Participants With Normal Renal Function
RECRUITING · Phase 1
-
A Study of Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment
ACTIVE NOT RECRUITING · Phase 1
-
"Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction"
COMPLETED · Phase 1
-
Pharmacokinetics and Safety of Fevipiprant in Patients With Renal Impairment Compared to Matched Healthy Subjects
COMPLETED · Phase 1
-
A Study of Effect of Selpercatinib (LY3527723) in Participants With Normal and Impaired Renal Function
COMPLETED · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
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.