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NCT04839809 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of CC-92480 Formulations in Healthy Adult Participants
A Phase 1 study of Healthy Volunteers, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT04839809: Completed Phase 1 study of Healthy Volunteers, sponsored by Celgene.
NCT04839809 is a Phase 1 study of Healthy Volunteers that has completed, run by Celgene. The registered enrollment target is 40 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04839809, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 1 study that will be conducted in 2 parts. Participants may participate in 1 part only. * Part 1 will be a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, and PK of CC-92480-02 (Formulation A) administered orally under fasted conditions in healthy adult participants. * Part 2 will be a randomized, open-label, 2 × 4 crossover study (Periods 1, 2, 3, and 4) to evaluate the relative bioavailability (RBA) of Formulation A versus Formulation B under fasted conditions and explore safety, tolerability, and PK effects of food on Formulation A and Formulation B in healthy adult participants.
Primary Outcome
Maximum plasma concentration of drug
Conditions Studied
Interventions
- OTHER Placebo
- DRUG CC-92480
Study Locations (1)
Texas
- PPD Phase 1 Clinic - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2021-01-19 |
| Est. Completion | 2021-10-08 |
| Phase | Phase 1 |
What the finished NCT04839809 record still lists
NCT04839809 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04839809 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04839809 about?
NCT04839809 is a clinical study titled "A Study to Assess Safety, Tolerability, and Pharmacokinetics of CC-92480 Formulations in Healthy Adult Participants". This is a Phase 1 study that will be conducted in 2 parts. Participants may participate in 1 part only. * Part 1 will be a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, and PK of CC-92480-02 (Formulation A) administered orally under ...
What is the current status of trial NCT04839809?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2021-01-19. Estimated completion is 2021-10-08.
What conditions does trial NCT04839809 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT04839809?
The interventions under investigation include: Placebo (OTHER), CC-92480 (DRUG).
Who is sponsoring clinical trial NCT04839809?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04839809 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04839809's enrollment target sits among peer trials
40 152nd of 283 higher than 124 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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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