A Drug-Drug Interaction Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of Apremilast

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
Amgen
Study ID
NCT01561963
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Subjects

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Apremilast — DRUG
    Tablets for oral administration
  • Rifampin Oral Capsules — DRUG
    Capsules for oral administration
  • Rifampin IV Solution — DRUG
    Intravenous (IV) solution

Study Details

The purpose of this study is to evaluate how the pharmacokinetics of apremilast may be affected by a single intravenous dose of rifampin and multiple oral doses of rifampin.

Key Dates

First listed
Mar 23, 2012
Start date
Feb 1, 2012
Status verified
May 2021
Primary completion
Apr 1, 2012
Completion
Apr 1, 2012

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Apremilast and Rifampin
    Participants received the following 3 treatment regimens: * A single oral dose of 30 mg apremilast on Day 1 (Period 1); * A single oral dose of 30 mg apremilast followed 5 minutes later by a 30-minute intravenous infusion of 600 mg rifampin on Day 5 (Period 2); * Once daily oral doses of 600 mg rifampin for 15 days (from Day 7 to Day 21) with a single oral dose of 30 mg apremilast co-administered with the rifampin dose on Day 20 (Period 3).

Primary Outcome Measure

Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUCt) of Apremilast [ Time Frame: Pre-dose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours following apremilast dosing on Days 1, 5, and 20 ]

Locations (1)

FacilityCityStateZIPSite coordinators
QuintilesOverland ParkKansas66211-

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Quintiles· Overland Park, KS

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