At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 34 enrolled
Drug / intervention
Apremilast Tablet +1 moredrug
Likely dose
Apremilast Tablet 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Open-Label, Randomized Three-Period, Six-Sequence Crossover Study In Healthy Adult Subjects To Evaluate The Bioavailablity Of An Oral Suspension Formulation Relative To The Tablet Formulation Of Apremilast And To Assess The Effect Of Food On The Pharmacokinetics Of The Oral Suspension Formulation
In Brief
A Phase 1 clinical trial evaluating Apremilast Tablet and Apremilast Oral Suspension for Healthy Volunteers. Completed, enrolled 34 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 2015
Enrollment StartJan 2016
Primary CompletionFeb 2016
TodayJul 2026
First PostedDec 29, 2015
Enrollment StartJan 5, 2016
Primary CompletionFeb 27, 2016
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 10.5 years ago
Interventions
Apremilast Tabletdrug
30 mg tablet
Apremilast Oral Suspensiondrug
30 mg oral suspension