Effects of Age and Sex on the Pharmacokinetics of Apremilast in Healthy Adults

Part of paid clinical trials in Lenexa, Kansas.

Sponsor
Amgen
Study ID
NCT01634191
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteer

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Apremilast — DRUG
    One oral 30 mg dose of apremilast

Study Details

The purpose of the study is to evaluate the effects of age and sex on the pharmacokinetics and safety of a single oral 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
Apr 1, 2012

Study Design

Enrollment
36 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Elderly: Apremilast 30 mg
    Participants aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.
  • Experimental: Younger: Apremilast 30 mg
    Participants aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.

Primary Outcome Measure

Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of Apremilast [ Time Frame: Day 1 predose and at 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, 12, 24, 36, and 48 hours after dosing. ]

Locations (2)

FacilityCityStateZIPSite coordinators
PRA InternationalLenexaKansas66219-
Clinical Development ServicesDallasTexas75247-

Find similar trials in Lenexa, KS

By research site
PRA International· Lenexa, KSClinical Development Services· Dallas, TX

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