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Apremilast Immediate Release

Phase 1

Healthy Volunteers | Small molecule | Other |Amgen Inc.|Last Updated: Jun 1, 2021

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Trial Design

RandomizedCONTROLLED

Total Trials1

Total Enrollment80

FDA Designations

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Clinical trial landscape

Apremilast Immediate Release · 1 trial · 1 indication

Phase 1 1

NCT02236988Study to Evaluate Pharmacokinetics of Prototype Modified-Release Formulations Of Apremilast in Healthy MenHealthy Volunteers

COMPLETED80 Analytics

PHASE1COMPLETED

Study to Evaluate Pharmacokinetics of Prototype Modified-Release Formulations Of Apremilast in Healthy Men

Healthy Volunteers

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Study Endpoints

Primary Endpoints

Group 1: Observed Maximum Plasma Concentration (Cmax) of Apremilast

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.

Group 1: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measured Time Point (AUC0-t) of Apremilast

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.

Group 1: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of Apremilast

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.

Group 1: Time to Observed Maximum Plasma Concentration (Tmax) of Apremilast

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.

Group 1: Half-life of Apremilast in Terminal Phase (T1/2)

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.

Group 1: Apparent Total Plasma Clearance (CL/F) of Apremilast

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.

Group 1: Apparent Total Volume of Distribution (Vz/F) of Apremilast

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.

Group 1: Relative Bioavailability of Apremilast Test Formulations Relative to Reference Corrected by Dose

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Relative bioavailability of each test formulation compared to the reference formulation corrected by dose, calculated as: (AUC0-∞/Dose\[test\]) / (AUC0-∞/Dose\[reference\]) \* 100%.

Group 1: Relative Bioavailability of Apremilast Test Formulations Relative to Reference

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Relative bioavailability of each test formulation compared to the reference formulation corrected by dose, calculated as: (AUC0-∞\[test\]) / (AUC0-∞\[reference\]) \* 100%.

Group 2: Observed Maximum Plasma Concentration (Cmax) of Apremilast

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.

Group 2: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measured Time Point (AUC0-t) of Apremilast

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.

Group 2: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of Apremilast

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.

Group 2: Time to Observed Maximum Plasma Concentration (Tmax) of Apremilast

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.

Group 2: Half-life of Apremilast in Terminal Phase (T1/2)

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.

Group 2: Apparent Total Plasma Clearance (CL/F) of Apremilast

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.

Group 2: Apparent Total Volume of Distribution (Vz/F) of Apremilast

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.

Group 2: Relative Bioavailability of Apremilast Test Formulations Relative to Reference Corrected by Dose

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Relative bioavailability of each test formulation compared to the reference formulation corrected by dose, calculated as: (AUC0-∞/Dose\[test\]) / (AUC0-∞/Dose\[reference\]) \* 100%.

Group 2: Relative Bioavailability of Apremilast Test Formulations Relative to Reference

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Relative bioavailability of each test formulation compared to the reference formulation corrected by dose, calculated as: (AUC0-∞\[test\]) / (AUC0-∞\[reference\]) \* 100%.

Group 3: Observed Maximum Plasma Concentration (Cmax) of Apremilast

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.

Group 3: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measured Time Point (AUC0-t) of Apremilast

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.

Group 3: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of Apremilast

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.

Group 3: Time to Observed Maximum Plasma Concentration (Tmax) of Apremilast

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.

Group 3: Half-life of Apremilast in Terminal Phase (T1/2)

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.

Group 3: Apparent Total Plasma Clearance (CL/F) of Apremilast

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.

Group 3: Relative Bioavailability of Apremilast Test Formulations Relative to Reference Corrected by Dose

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Relative bioavailability of each test formulation compared to the reference formulation corrected by dose, calculated as: (AUC0-∞/Dose\[test\]) / (AUC0-∞/Dose\[reference\]) \* 100%.

Group 3: Relative Bioavailability of Apremilast Test Formulations Relative to Reference

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Relative bioavailability of each test formulation compared to the reference formulation corrected by dose, calculated as: (AUC0-∞\[test\]) / (AUC0-∞\[reference\]) \* 100%.

Group 4: Observed Maximum Plasma Concentration (Cmax) of Apremilast

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.

Group 4: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measured Time Point (AUC0-t) of Apremilast

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.

Group 4: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of Apremilast

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.

Group 4: Time to Observed Maximum Plasma Concentration (Tmax) of Apremilast

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.

Group 4: Half-life of Apremilast in Terminal Phase (T1/2)

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.

Group 4: Apparent Total Plasma Clearance (CL/F) of Apremilast

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.

Group 4: Apparent Total Volume of Distribution (Vz/F) of Apremilast

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.

Group 4: Relative Bioavailability of Apremilast Test Formulations Relative to Reference Corrected by Dose

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Relative bioavailability of each test formulation compared to the reference formulation corrected by dose, calculated as: (AUC0-∞/Dose\[test\]) / (AUC0-∞/Dose\[reference\]) \* 100%.

Group 4: Relative Bioavailability of Apremilast Test Formulations Relative to Reference

IR reference formulation: 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 first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.

Relative bioavailability of each test formulation compared to the reference formulation corrected by dose, calculated as: (AUC0-∞\[test\]) / (AUC0-∞\[reference\]) \* 100%.

Secondary Endpoints

Group 1: Number of Participants With Treatment-emergent Adverse Events

Adverse events were collected for 7 to 10 days after each treatment.

Group 2: Number of Participants With Treatment-emergent Adverse Events

Adverse events were collected for 7 to 10 days after each treatment.

Group 3: Number of Participants With Treatment-emergent Adverse Events

Adverse events were collected for 7 to 10 days after each treatment.

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Study Design & Arms

AllocationRANDOMIZED

MaskingNONE

ModelCROSSOVER

PurposeOTHER

Treatment Arms

Arm	Type	Description
Group 1	EXPERIMENTAL	Participants received the following 4 treatments, given in 4 possible sequences (ADBC, BACD, CBDA, and DCAB) with 7 to 10 days between each treatment: A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) B) A single oral dose 75 mg apremilast tablet prototype MR 1 C) A single oral dose 75 mg apremilast tablet prototype MR 2 D) A single oral dose 75 mg apremilast capsule prototype MR 3
Group 2	EXPERIMENTAL	Participants received the following 4 treatments, given in 4 possible sequences (AGEF, EAFG, FEGA, and GFAE) with 7 to 10 days between each treatment: A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) E) A single oral dose 75 mg apremilast capsule prototype MR 4 F) A single oral dose 75 mg apremilast capsule prototype MR 5 G) A single oral dose 75 mg apremilast capsule prototype MR 6
Group 3	EXPERIMENTAL	Participants received the following 3 treatments, given in 6 possible sequences (AIJ, IJA, JAI, AJI, IAJ, or JIA) with 7 to 10 days between each treatment: A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) I) A single oral dose 80 mg apremilast capsule prototype MR 8 J) A single oral dose 80 mg apremilast capsule prototype MR 9
Group 4	EXPERIMENTAL	Participants received the following 5 treatments, given in 10 possible sequences (ALOMN, LMANO, MNLOA, NOMAL, OANLM, NMOLA, ONAML, AOLNM, LAMON, or MLNAO) with 7 to 10 days between each treatment: A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) L) A single oral dose 80 mg apremilast capsule prototype MR 11 M) A single oral dose 80 mg apremilast capsule prototype MR 12 N) A single oral dose 80 mg apremilast capsule prototype MR 13 O) A single oral dose 80 mg apremilast capsule prototype MR 14

Interventions

Name	Type	Description
Apremilast Immediate Release	DRUG	30 mg immediate release tablets
Apremilast Modified Release 1	DRUG	75 mg oral tablet of prototype modified release (MR) 1
Apremilast Modified Release 2	DRUG	75 mg oral tablet of prototype MR 2
Apremilast Modified Release 3	DRUG	75 mg oral capsule of prototype MR 3
Apremilast Modified Release 4	DRUG	75 mg oral capsule of prototype MR 4
Apremilast Modified Release 5	DRUG	75 mg oral capsule of prototype MR 5
Apremilast Modified Release 6	DRUG	75 mg oral capsule of prototype MR 6
Apremilast Modified Release 8	DRUG	80 mg oral capsule of prototype MR 8
Apremilast Modified Release 9	DRUG	80 mg oral capsule of prototype MR 9
Apremilast Modified Release 11	DRUG	80 mg oral capsule of prototype MR 11
Apremilast Modified Release 12	DRUG	80 mg oral capsule of prototype MR 12
Apremilast Modified Release 13	DRUG	80 mg oral capsule of prototype MR 13
Apremilast Modified Release 14	DRUG	80 mg oral capsule of prototype MR 14

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Eligibility Criteria

Age Range18 Years to 55 Years

SexMALE

Healthy VolunteersYes

Study Sites1

Inclusion Criteria: Subjects must satisfy ALL of the following criteria to be eligible for enrollment into the study: 1. Must understand and voluntarily sign a written informed consent form prior to any study-related procedures being performed. 2. Must be able to communicate with the investigator,...

Countries:United States

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Frequently asked questions about Apremilast Immediate Release

What is Apremilast Immediate Release used for?

Apremilast Immediate Release is a small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating its pharmacokinetics in healthy men. The drug is being developed by Amgen Inc. and is not yet approved for any indication.

Who makes Apremilast Immediate Release?

Apremilast Immediate Release 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 Immediate Release in?

Apremilast Immediate Release is in Phase 1 clinical development. It has one completed trial, NCT02236988, which studied the pharmacokinetics of prototype modified-release formulations in healthy men. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Apremilast Immediate Release in?

Apremilast Immediate Release has one clinical trial, NCT02236988, titled 'Study to Evaluate Pharmacokinetics of Prototype Modified-Release Formulations Of Apremilast in Healthy Men.' This Phase 1 trial was completed in the United States, enrolled 80 healthy male participants aged 18 years and older, and was controlled but not double-blinded.

Is Apremilast Immediate Release the same as apremilast?

Apremilast Immediate Release is a formulation of apremilast, a small molecule. The trial NCT02236988 evaluated prototype modified-release formulations of apremilast, indicating that the immediate release version is one of several formulations being studied. The drug is in Phase 1 development for healthy volunteers.