CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 80 enrolled
Drug / intervention
Apremilast Immediate Release +12 moredrug
Likely dose
Apremilast Immediate Release 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.

Search/NCT02236988
NCT02236988Phase 1Completed

A Phase 1, Open-Label, Single Center Study to Evaluate the Pharmacokinetics of Prototype Modified-Release Formulations Of Apremilast (CC-10004) in Healthy Male Subjects

Amgen·interventional·Posted Sep 11, 2014·Updated Jun 1, 2021

In Brief

A Phase 1 clinical trial evaluating Apremilast Immediate Release, Apremilast Modified Release 1, and 11 other interventions for Healthy Volunteers. Completed, enrolled 80 participants across 1 site.

Detailed Summary

This study will assess up to 12 different oral formulations of apremilast to determine how much apremilast is absorbed by the body compared to a reference formulation.

Study Details

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

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 11, 2014
Enrollment StartJan 7, 2014
Primary CompletionSep 11, 2014
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.8 years ago

Interventions

Apremilast Immediate Releasedrug

30 mg immediate release tablets

Apremilast Modified Release 1drug

75 mg oral tablet of prototype modified release (MR) 1

Apremilast Modified Release 2drug

75 mg oral tablet of prototype MR 2

Apremilast Modified Release 3drug

75 mg oral capsule of prototype MR 3

Apremilast Modified Release 4drug

75 mg oral capsule of prototype MR 4

Apremilast Modified Release 5drug

75 mg oral capsule of prototype MR 5

Apremilast Modified Release 6drug

75 mg oral capsule of prototype MR 6

Apremilast Modified Release 8drug

80 mg oral capsule of prototype MR 8

Apremilast Modified Release 9drug

80 mg oral capsule of prototype MR 9

Apremilast Modified Release 11drug

80 mg oral capsule of prototype MR 11

Apremilast Modified Release 12drug

80 mg oral capsule of prototype MR 12

Apremilast Modified Release 13drug

80 mg oral capsule of prototype MR 13

Apremilast Modified Release 14drug

80 mg oral capsule of prototype MR 14