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

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.

Conditions

• Healthy Volunteers

Interventions

DRUG

Apremilast Immediate Release

30 mg immediate release tablets

DRUG

Apremilast Modified Release 1

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

DRUG

Apremilast Modified Release 2

75 mg oral tablet of prototype MR 2

DRUG

Apremilast Modified Release 3

75 mg oral capsule of prototype MR 3

DRUG

Apremilast Modified Release 4

75 mg oral capsule of prototype MR 4

DRUG

Apremilast Modified Release 5

75 mg oral capsule of prototype MR 5

DRUG

Apremilast Modified Release 6

75 mg oral capsule of prototype MR 6

DRUG

Apremilast Modified Release 8

80 mg oral capsule of prototype MR 8

DRUG

Apremilast Modified Release 9

80 mg oral capsule of prototype MR 9

DRUG

Apremilast Modified Release 11

80 mg oral capsule of prototype MR 11

DRUG

Apremilast Modified Release 12

80 mg oral capsule of prototype MR 12

DRUG

Apremilast Modified Release 13

80 mg oral capsule of prototype MR 13

DRUG

Apremilast Modified Release 14

80 mg oral capsule of prototype MR 14

Sponsors & Collaborators

• Amgen

  lead INDUSTRY

Principal Investigators

• MD · Amgen

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-01-07

Primary Completion

2014-09-11

Completion

2014-09-11

Countries

• United States

Study Locations