Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of Apremilast in Healthy Adult Male Korean Subjects

Sponsor
Amgen
Study ID
NCT02802735
Phase
PHASE1
Status
Completed

Conditions

  • Pharmacokinetics

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Apremilast — DRUG
    Tablet for oral administration
  • Placebo — DRUG
    Tablet for oral administration

Study Details

This two-part study was designed to evaluate the pharmacokinetics (PK) of single and multiple doses of apremilast in healthy adult Korean males.

Key Dates

First listed
Jun 16, 2016
Start date
Jun 22, 2016
Status verified
Jun 2021
Primary completion
Aug 5, 2016
Completion
Aug 5, 2016

Study Design

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

Arms

  • Experimental: Part 1: Apremilast 20 mg
    A single oral dose of 20 mg apremilast.
  • Experimental: Part 1: Apremilast 30 mg
    A single oral dose of 30 mg apremilast.
  • Experimental: Part 1: Apremilast 40 mg
    A single oral dose of 40 mg apremilast.
  • Experimental: Part 2: Apremilast 30 mg BID
    30 mg apremilast orally twice a day (BID) for 14 days.
  • Placebo Comparator: Part 2: Placebo
    Matching placebo orally twice a day for 14 days.

Primary Outcome Measure

Part 1: Maximum Observed Plasma Concentration (Cmax) of Apremilast [ Time Frame: Day 1 of each treatment period at predose (0 hour) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours post-dose. ]

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