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NCT04096105 · ClinicalTrials.gov registry record · Phase 1
Japanese Pharmacokinetic Bridging Study for CC-93538
A Phase 1 study of Healthy Volunteers, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT04096105: Completed Phase 1 study of Healthy Volunteers, sponsored by Celgene.
NCT04096105 is a Phase 1 study of Healthy Volunteers that has completed, run by Celgene. The registered enrollment target is 48 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04096105, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label, randomized, parallel design study to evaluate the PK, safety, tolerability and immunogenicity of single SC doses of CC-93538 in healthy Japanese and Caucasian adult subjects. A total of approximately 48 subjects, 24 Japanese and 24 Caucasians, will be enrolled. Japanese subjects will be enrolled first and randomized 1:1 to receive a single SC dose of either 180 mg or 360 mg CC-93538. Caucasian subjects will then be enrolled and matched to Japanese subjects (1:1) by weight (± 20%) and receive the same single SC dose of either 180 mg or 360 mg CC-93538.
Primary Outcome
Area under the concentration-time curve calculated from time zero to the last measured concentration
Conditions Studied
Interventions
- DRUG CC-93538
Study Locations (1)
California
- Anaheim Clinical Trials - Anaheim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2019-10-14 |
| Est. Completion | 2020-01-30 |
| Phase | Phase 1 |
What the finished NCT04096105 record still lists
NCT04096105 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 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention - of which CC-93538 is the first listed.
NCT04096105 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04096105 about?
NCT04096105 is a clinical study titled "Japanese Pharmacokinetic Bridging Study for CC-93538". This is an open-label, randomized, parallel design study to evaluate the PK, safety, tolerability and immunogenicity of single SC doses of CC-93538 in healthy Japanese and Caucasian adult subjects. A total of approximately 48 subjects, 24 Japanese and 24 Caucasians, will be enrolled. Japanese subje...
What is the current status of trial NCT04096105?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2019-10-14. Estimated completion is 2020-01-30.
What conditions does trial NCT04096105 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT04096105?
The interventions under investigation include: CC-93538 (DRUG).
Who is sponsoring clinical trial NCT04096105?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04096105 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04096105's enrollment target sits among peer trials
48 142nd of 283 higher than 140 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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