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NCT02641353 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate Bioavailability of Apremilast Oral Suspension Relative to Tablet and to Assess Effect of Food on the Pharmacokinetics (PK) of the Oral Suspension
A Phase 1 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT02641353: Completed Phase 1 study, sponsored by Amgen.
NCT02641353 is a Phase 1 study that has completed, run by Amgen. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02641353, a Phase 1 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
The purpose of this study is to assess how much of apremilast is found in the blood unchanged when administered as an oral suspension compared to when it is administered as a tablet formulation. The effect of food on apremilast oral suspension will also be evaluated. In addition, information on the safety and tolerability of apremilast will be obtained.
Primary Outcome
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Interventions
- DRUG Apremilast Tablet
- DRUG Apremilast Oral Suspension
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2016-01-05 |
| Est. Completion | 2016-02-27 |
| Phase | Phase 1 |
What the finished NCT02641353 record still lists
NCT02641353 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 2 interventions - of which Apremilast Tablet is the first listed.
NCT02641353 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02641353 about?
NCT02641353 is a clinical study titled "Study to Evaluate Bioavailability of Apremilast Oral Suspension Relative to Tablet and to Assess Effect of Food on the Pharmacokinetics (PK) of the Oral Suspension". The purpose of this study is to assess how much of apremilast is found in the blood unchanged when administered as an oral suspension compared to when it is administered as a tablet formulation. The effect of food on apremilast oral suspension will also be evaluated. In addition, information on the ...
What is the current status of trial NCT02641353?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2016-01-05. Estimated completion is 2016-02-27.
What interventions are being tested in trial NCT02641353?
The interventions under investigation include: Apremilast Tablet (DRUG), Apremilast Oral Suspension (DRUG).
Who is sponsoring clinical trial NCT02641353?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02641353's enrollment target sits among peer trials
34 1273rd of 2000 higher than 721 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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