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NCT03803644 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single Ascending Doses of CC-92480 in Healthy Subjects
A Phase 1 study of Healthy Volunteer, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
- 1
- Study location
NCT03803644: Completed Phase 1 study of Healthy Volunteer, sponsored by Celgene.
NCT03803644 is a Phase 1 study of Healthy Volunteer that has completed, run by Celgene. The registered enrollment target is 56 participants, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03803644, a Phase 1 study of Healthy Volunteer, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a two-part study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CC-92480 and explore the effect of food on the bioavailability of CC-92480 in healthy subjects. Part 1: Part 1 is a single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and pharmacodynamics (PD) of CC-92480 following administration of single oral doses in healthy adult subjects. Part 1 will consist of escalating single doses in sequential groups. Approximately 40 subjects will be enrolled into 5 planned dose level cohorts. Each dose level cohort will consist of 8 subjects; 6 subjects will receive CC-92480 and 2 subjects will receive placebo according to the randomization schedule. Part 2 Part 2 is a single-center, open-label, randomized, 2-period, 2-way crossover study to explore the effect of food (Food and Drug Administration \[FDA\] standard high-fat breakfast) on the single-dose PK of CC-92480 in healthy adult subjects.
Primary Outcome
Maximum plasma concentration of drug
Conditions Studied
Interventions
- DRUG CC-92480
Study Locations (1)
Florida
- Covance-Daytona Beach - Daytona Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2018-12-21 |
| Est. Completion | 2019-05-28 |
| Phase | Phase 1 |
What the finished NCT03803644 record still lists
NCT03803644 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Healthy Volunteer appearing as the primary indexed condition, and to 1 intervention - of which CC-92480 is the first listed.
NCT03803644 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT03803644 about?
NCT03803644 is a clinical study titled "Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single Ascending Doses of CC-92480 in Healthy Subjects". This is a two-part study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CC-92480 and explore the effect of food on the bioavailability of CC-92480 in healthy subjects. Part 1: Part 1 is a single-center, randomized, double-blind, placebo-controlled study to evaluate ...
What is the current status of trial NCT03803644?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2018-12-21. Estimated completion is 2019-05-28.
What conditions does trial NCT03803644 study?
This clinical trial studies the following conditions: Healthy Volunteer.
What interventions are being tested in trial NCT03803644?
The interventions under investigation include: CC-92480 (DRUG).
Who is sponsoring clinical trial NCT03803644?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03803644 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03803644's enrollment target sits among peer trials
56 56th of 112 higher than 57 of 112 other Healthy Volunteer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteer 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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