Effect of Food on the Pharmacokinetics of Apremilast (CC-10004) in Healthy Adults

Part of paid clinical trials in Austin, Texas.

Sponsor
Amgen
Study ID
NCT01634178
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteer

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The purpose of the study is to evaluate the effects of a high fat meal on the pharmacokinetics of a single dose of 30 mg apremilast in healthy adults.

Key Dates

First listed
Jul 6, 2012
Start date
Feb 1, 2012
Status verified
Mar 2021
Primary completion
Mar 1, 2012
Completion
Mar 1, 2012

Study Design

Enrollment
46 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Sequence 1: Apremilast Fasted / Fed
    In Period 1 participants will receive a single 30 mg apremilast tablet administered under fasted conditions and in Period 2 participants will receive a single 30 mg apremilast tablet administered after a high fat meal.
  • Experimental: Sequence 2: Apremilast Fed / Fasted
    In Period 1 participants will receive a single 30 mg apremilast tablet administered after a high fat meal and in Period 2 participants will receive a single 30 mg apremilast tablet administered under fasted conditions.

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) of Apremilast [ Time Frame: Day 1 of each treatment period at pre-dose, and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing. ]

Locations (1)

FacilityCityStateZIPSite coordinators
PPD DevelopmentAustinTexas787844-

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By research site
PPD Development· Austin, TX

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