Study to Evaluate Bioavailability of Apremilast Oral Suspension Relative to Tablet and to Assess Effect of Food on the Pharmacokinetics (PK) of the Oral Suspension

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
Amgen
Study ID
NCT02641353
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 assess how much of apremilast is found in the blood unchanged when administered as an oral suspension compared to when it is administered as a tablet formulation. The effect of food on apremilast oral suspension will also be evaluated. In addition, information on the safety and tolerability of apremilast will be obtained.

Key Dates

First listed
Dec 29, 2015
Start date
Jan 5, 2016
Status verified
Jul 2021
Primary completion
Feb 27, 2016
Completion
Feb 27, 2016

Study Design

Enrollment
34 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Treatment A: Apremilast 30 mg Tablet - Fasted
    A single oral dose of 30 mg apremilast tablet after an overnight fast.
  • Experimental: Treatment B: Apremilast 30 mg Oral Suspension - Fasted
    A single oral dose of 30 mg apremilast oral suspension formulation (6 mL) after an overnight fast.
  • Experimental: Treatment C - Apremilast 30 mg Oral Suspension - Fed
    A single oral dose of 30 mg apremilast oral suspension formulation (6 mL) after a high-fat meal.

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) of Apremilast [ Time Frame: Predose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60 and 72 hours after dosing on day 1 of each treatment period. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Covance Clinical Research Unit IncMadisonWisconsin53704-

Find similar trials in Madison, WI

By research site
Covance Clinical Research Unit Inc· Madison, WI

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