A Phase 1, Open-label, Three-period, Fixed-sequence Study to Evaluate the Effects of Rifampin on the Pharmacokinetics of Apremilast (CC-10004) in Healthy Subjects

Amgen1 个研究点分布在 1 个国家目标入组 21 人开始时间: 2012年2月1日最近更新: 2021年6月9日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Amgen
入组人数: 21
试验地点: 1
主要终点: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC∞) of Apremilast

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Other
盲法: None

入排标准

年龄范围: 18 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy male or female subjects of any ethnic origin between ages of 18 and 55 with a body mass index between 18 and 33

排除标准

•Recent history (i.e., within 3 years) of any clinically significant neurological, gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, endocrine, hematological, dermatological, psychological, allergic or other major disorders.
•Use of any prescribed or non-prescribed systemic or topical medication (including vitamins and herbal medicines, e.g. St. John's Wort) within 30 days of the first dose, unless an exception is granted by the sponsor.
•Presence of any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, and excretion, or plans to have elective or medical procedures during the conduct of the trial.
•Exposure to an investigational drug (new chemical entity) within 30 days prior to the first dose administration

研究组 & 干预措施

Apremilast and Rifampin

Experimental

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).

干预措施: Apremilast (Drug)

Apremilast and Rifampin

Experimental

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).

干预措施: Rifampin Oral Capsules (Drug)

Apremilast and Rifampin

Experimental

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).

干预措施: Rifampin IV Solution (Drug)

结局指标

主要结局

Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC∞) of Apremilast

时间窗: 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