An Open-Label, Single-Dose Study to Evaluate the Effects of Age and Sex on the Pharmacokinetics of Apremilast (CC-10004) in Healthy Subjects

Amgen2 个研究点分布在 1 个国家目标入组 36 人开始时间: 2012年2月1日最近更新: 2021年4月14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: 36
试验地点: 2
主要终点: Maximum Observed Plasma Concentration of Apremilast by Sex

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 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.

详细描述

This is an open-label, parallel group study where eligible elderly adults (aged 65-85 years inclusive) and younger adults (aged 18-55 years inclusive) and who are matched to the elderly participants by sex and body mass index (BMI) (± 10%) will receive a single dose of 30 mg apremilast under fasting conditions.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Other
盲法: None

入排标准

年龄范围: 18 Years 至 85 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Inclusion Criteria for elderly group
•Healthy male or female subjects of any ethnic origin between ages of 65 and 85 inclusive with a body mass index (BMI) between 18 and
•Females must have been surgically sterilized at least 6 months prior to screening or be postmenopausal (to be confirmed by lab tests).
•Males must agree to use latex or polyurethane condoms when engaging in sex during the study and for at least 28 days after dosing.
•Elderly subjects with stable, chronic medical condition may be eligible if the condition is well-controlled and medications do not interfere with study procedures or pharmacokinetic interpretation
•Inclusion Criteria for younger group:
•Healthy male or female of any ethnic origin between the ages of 18 and 55 inclusive with a BMI between 18 and
•Males must agree to use latex or polyurethane condoms when engaging in sex during the study and for at least 28 days after dosing.
•Females who are able to become pregnant have a negative pregnancy test at screening and baseline, and must agree to use one of the following:
•a highly effective form of contraception (ex. Non-oral hormonal, intrauterine device) OR
•oral hormonal contraceptive plus one additional form of barrier contraception OR
•two forms of barrier contraception These must be effective by the time of screening. For younger females who are not able to become pregnant, the conditions for the elderly females will apply.

排除标准

•Any condition, including the presence of laboratory abnormalities, or psychiatric illness, that would prevent the subject from signing the Informed Consent form, places the subject at unacceptable risk if he were to participate in the study, or confounds the ability to interpret data from the study.
•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 or 5 half-lives of that investigational drug, if known (whichever is longer).
•Subjects with known serum hepatitis, is a known carrier of hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus antibody.
•Subjects who have used prescription systemic or topical medications within 30 days of dosing, unless it is being used to treat a stable, chronic medical condition. This includes medication that is an inhibitor or inducer of P-glycoprotein transporter and CYP-3A4/5 used within 14 days of dosing.

研究组 & 干预措施

Elderly: Apremilast 30 mg

Experimental

Participants aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1.

干预措施: Apremilast (Drug)

Younger: Apremilast 30 mg

Experimental

Participants aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.

干预措施: Apremilast (Drug)