Recent Updates
Recently added Catalysts

Apremilast IR

Phase 1

Healthy Volunteers | Small molecule | Other |Amgen Inc.|Last Updated: Jul 22, 2021

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment144

FDA Designations

No designations recorded

Clinical trial landscape

Apremilast IR · 1 trial · 1 indication

Phase 1 1
NCT02777554A Study to Evaluate the Pharmacokinetic Exposure of 2 Formulations of Apremilast in Healthy AdultsHealthy Volunteers
COMPLETED144 Analytics
PHASE1COMPLETED
A Study to Evaluate the Pharmacokinetic Exposure of 2 Formulations of Apremilast in Healthy Adults
Healthy Volunteers
NCT02777554144
Unlock trial analytics

Study Endpoints

Primary Endpoints

Part 1: Peak Maximum Plasma Concentration (Cmax) of Apremilast
Apremilast IR: Day 7 predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, and 24 hours after the morning dose. Apremilast XL: Day 7 predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours after the morning dose.
Part 1: Area Under the Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC0-24) of Apremilast
Apremilast IR: Day 7 predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, and 24 hours after the morning dose. Apremilast XL: Day 7 predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours after the morning dose.
Part 2: Peak Maximum Plasma Concentration (Cmax) of Apremilast
Apremilast IR: Predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the morning dose. Apremilast XL: Predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, 60, and 72 hours postdose.
Part 2: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Observable Concentration (AUC0-t) of Apremilast
Apremilast IR: Predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the morning dose. Apremilast XL: Predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, 60, and 72 hours postdose.
Part 2: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of Apremilast
Apremilast IR: Predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the morning dose. Apremilast XL: Predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, 60, and 72 hours postdose.

Secondary Endpoints

Number of Participants With Treatment-emergent Adverse Events
Part 1: Up to 7 days after last dose in each treatment period (14 days); Part 2: Up to 7 days after each dose.
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: Apremilast 30 mg IR BID / Apremilast 75 mg XL QDEXPERIMENTALParticipants received apremilast 30 mg immediate release (IR) tablet twice a day (BID) for 7 days in treatment period 1 then apremilast 75 mg extended release (XL) formulation once a day (QD) for 7 days in treatment period 2.
Part 1: Apremilast 75 mg XL QD / Apremilast 30 mg IR BIDEXPERIMENTALParticipants received apremilast 75 mg XL formulation once a day for 7 days in treatment period 1 then apremilast 30 mg IR tablet twice a day for 7 days in treatment period 2.
Part 2: Sequence 1EXPERIMENTALParticipants received a single dose of apremilast in each of 4 treatment periods according to the following: Treatment period 1: Apremilast 30 mg IR tablet under fasted conditions; Treatment period 2: Apremilast 75 mg XL formulation after a high-fat meal; Treatment period 3: Apremilast 75 mg XL formulation under fasted conditions; Treatment period 4: Apremilast 75 mg XL formulation after a standard meal.
Part 2: Sequence 2EXPERIMENTALParticipants received a single dose of apremilast in each of 4 treatment periods according to the following: Treatment period 1: Apremilast 75 mg XL formulation under fasted conditions; Treatment period 2: Apremilast 30 mg IR tablet under fasted conditions; Treatment period 3: Apremilast 75 mg XL formulation after a standard meal; Treatment period 4: Apremilast 75 mg XL formulation after a high-fat meal.
Part 2: Sequence 3EXPERIMENTALParticipants received a single dose of apremilast in each of 4 treatment periods according to the following: Treatment period 1: Apremilast 75 mg XL formulation after a standard meal; Treatment period 2: Apremilast 75 mg XL formulation under fasted conditions; Treatment period 3: Apremilast 75 mg XL formulation after a high-fat meal; Treatment period 4: Apremilast 30 mg IR tablet under fasted conditions.
Part 2: Sequence 4EXPERIMENTALParticipants received a single dose of apremilast in each of 4 treatment periods according to the following: Treatment period 1: Apremilast 75 mg XL formulation after a high-fat meal; Treatment period 2: Apremilast 75 mg XL formulation after a standard meal; Treatment period 3: Apremilast 30 mg IR tablet under fasted conditions; Treatment period 4: Apremilast 75 mg XL formulation under fasted conditions.

Interventions

NameTypeDescription
Apremilast IRDRUGApremilast immediate release tablet
Apremilast XLDRUGApremilast extended release formulation tablet
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: Subjects must satisfy the following criteria to be enrolled in the study (Part 1 and Part 2): 1. Must understand and voluntarily sign a written Informed consent form (ICF) prior to any study-related procedures being performed. 2. Must be able to communicate with the investigato...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about Apremilast IR

What is Apremilast IR used for?

Apremilast IR is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating its pharmacokinetic exposure in healthy adults. The drug is being developed by Amgen Inc.

Who makes Apremilast IR?

Apremilast IR is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker AMGN. The drug is currently in Phase 1 clinical development, with one completed trial in healthy volunteers.

What phase is Apremilast IR in?

Apremilast IR is in Phase 1 clinical development. It is an investigational drug, not yet approved, and has completed one Phase 1 trial in healthy volunteers. The trial evaluated the pharmacokinetic exposure of two formulations of the drug.

What clinical trials is Apremilast IR in?

Apremilast IR has one completed clinical trial, NCT02777554, titled "A Study to Evaluate the Pharmacokinetic Exposure of 2 Formulations of Apremilast in Healthy Adults." This Phase 1 study enrolled 144 participants in the United States and was completed.

Is Apremilast IR the same as apremilast?

Apremilast IR is a formulation of apremilast, a small molecule. The completed Phase 1 trial, NCT02777554, compared the pharmacokinetic exposure of two formulations of apremilast in healthy adults. Apremilast IR is the immediate-release version being studied.