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NCT04139226 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety, Tolerability Pharmacokinetics, and Pharmacodynamics of a New Spray Dried Dispersion (SDD) Formulation of CC-11050 After Single Dose of CC-11050 and to Evaluate the Pharmacokinetics of CC-11050 Under Fasted and Fed Conditions and After Coadministration With Omeprazole
A Phase 1 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT04139226 is a Phase 1 study that has completed, run by Amgen. The registered enrollment target is 44 participants.
The verdict
NCT04139226, a Phase 1 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
This is a two-part study to be conducted at single study center, (additional center(s) may be selected if needed) to assess the safety, tolerability, PK and PD parameters for a new SDD formulation of CC-11050 in healthy subjects. The effects of a high-fat meal and omeprazole will also be assessed. Blood samples will be collected at prespecified times for PK, clinical laboratory safety assessments, PD (Part 1 only), and/or exploratory analyses. Safety will be monitored throughout the study from the time the ICF is signed through study completion.
Interventions
- DRUG CC-11050
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2019-08-28 |
| Est. Completion | 2020-02-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04139226
The ClinicalTrials.gov registry entry for NCT04139226 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CC-11050 is the first listed.
NCT04139226 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04139226 about?
NCT04139226 is a clinical study titled "A Study to Evaluate the Safety, Tolerability Pharmacokinetics, and Pharmacodynamics of a New Spray Dried Dispersion (SDD) Formulation of CC-11050 After Single Dose of CC-11050 and to Evaluate the Pharmacokinetics of CC-11050 Under Fasted and Fed Conditions and After Coadministration With Omeprazole". This is a two-part study to be conducted at single study center, (additional center(s) may be selected if needed) to assess the safety, tolerability, PK and PD parameters for a new SDD formulation of CC-11050 in healthy subjects. The effects of a high-fat meal and omeprazole will also be assessed. B...
What is the current status of trial NCT04139226?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2019-08-28. Estimated completion is 2020-02-27.
What interventions are being tested in trial NCT04139226?
The interventions under investigation include: CC-11050 (DRUG).
Who is sponsoring clinical trial NCT04139226?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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