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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03803644
The ClinicalTrials.gov registry entry for NCT03803644 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (72% lower). The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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