CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 144 enrolled
Drug / intervention
Apremilast IR +1 moredrug
Likely dose
Apremilast IR (twice-daily formulation) and Apremilast XL (once-daily formulation) — specific doses not statedAI-extracted
Key inclusion· 7
  • ✓Age 18-55 years, any race
  • ✓Good health with no clinically significant laboratory abnormalities
  • ✓BMI 18-33 kg/m²
  • ✓Vital signs at screening: systolic BP 90-140 mmHg, diastolic BP 50-90 mmHg, pulse 40-110 bpm, afebrile
Key exclusion· 9
  • ✕History of clinically significant neurological, psychiatric, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, or other major disorders
  • ✕Any prescribed systemic or topical medication within 30 days before dosing (except hormonal contraception)
  • ✕Any non-prescribed systemic or topical medication, vitamins, or herbal medicines within 14 days before dosing
  • ✕Surgical or medical condition affecting drug absorption/distribution/metabolism/excretion (bariatric procedure, bowel resection, IBS, Crohn's disease)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02777554
NCT02777554Phase 1Completed
CompareCT.gov

A Phase 1, Open Label, Randomized, Two Part Study to Evaluate the Pharmacokinetic Exposure of a Once-Daily (QD) Apremilast Formulation Relative to the Twice-Daily (BID) Reference Immediate Release (IR) Tablet and the Effect of Food on the QD Apremilast Formulation in Healthy Subjects.

Amgen·interventional·Posted May 19, 2016·Updated Jul 22, 2021

In Brief

A Phase 1 clinical trial evaluating Apremilast IR and Apremilast XL for Healthy Volunteers. Completed, enrolled 144 participants across 2 sites.

Detailed Summary

The purpose of this study is to evaluate the relative bioavailability of apremilast once-daily formulation relative to a twice daily formulation when administered as multiple doses (Part 1), and when administered as a single dose under fasting and fed conditions (Part 2). Information on safety and tolerability will also be obtained.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 19, 2016
Enrollment StartAug 17, 2016
Primary CompletionNov 22, 2016
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 10.1 years ago

Interventions

Apremilast IRdrug

Apremilast immediate release tablet

Apremilast XLdrug

Apremilast extended release formulation tablet