A Study to Evaluate the Pharmacokinetic Exposure of 2 Formulations of Apremilast in Healthy Adults

Part of paid clinical trials in Daytona Beach, Florida.

Sponsor
Amgen
Study ID
NCT02777554
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The purpose of this study is to evaluate the relative bioavailability of apremilast once-daily formulation relative to a twice daily formulation when administered as multiple doses (Part 1), and when administered as a single dose under fasting and fed conditions (Part 2). Information on safety and tolerability will also be obtained.

Key Dates

First listed
May 19, 2016
Start date
Aug 17, 2016
Status verified
Jun 2021
Primary completion
Nov 22, 2016
Completion
Nov 22, 2016

Study Design

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

Arms

  • Experimental: Part 1: Apremilast 30 mg IR BID / Apremilast 75 mg XL QD
    Participants 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.
  • Experimental: Part 1: Apremilast 75 mg XL QD / Apremilast 30 mg IR BID
    Participants 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.
  • Experimental: Part 2: Sequence 1
    Participants 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.
  • Experimental: Part 2: Sequence 2
    Participants 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.
  • Experimental: Part 2: Sequence 3
    Participants 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.
  • Experimental: Part 2: Sequence 4
    Participants 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.

Primary Outcome Measure

Part 1: Peak Maximum Plasma Concentration (Cmax) of Apremilast [ Time Frame: 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. ]

Locations (2)

FacilityCityStateZIPSite coordinators
Covance-Daytona BeachDaytona BeachFlorida32117-
Covance Clinical Research Unit IncMadisonWisconsin53704-

Find similar trials in Daytona Beach, FL

By research site
Covance-Daytona Beach· Daytona Beach, FLCovance Clinical Research Unit Inc· Madison, WI

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