A Phase 1, Sequential Drug Interaction Study to Evaluate the Effect of CYP3A4 and P-glycoprotein Inhibition by Itraconazole or Induction by Rifampicin on the Pharmacokinetics of Ecopipam and Its Metabolites in Healthy Subjects

Emalex Biosciences Inc.1 个研究点分布在 1 个国家目标入组 45 人开始时间: 2024年1月18日最近更新: 2024年8月28日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Emalex Biosciences Inc.
入组人数: 45
试验地点: 1
主要终点: AUC0-inf of ecopipam when administered without rifampicin

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

This is a single center, 2-Part, Phase 1, open-label, fixed-sequence, drug-drug interaction study designed to compare the PK of ecopipam when administered alone and in combination with itraconazole (Part 1) or rifampicin (Part 2) in healthy subjects.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Basic Science
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

•Male subjects or femail subjects of non-childbearing potential
•≥18 and ≤55 years of age
•BMI >18.5 and <30.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
•Subjects must be healthy, as determined by the Investigator, based on medical history, physical examination, ECG, vital signs, and standard panel of blood and laboratory tests at Screening.
•Sexually active males must use a double barrier method of contraception during the study and for at least 90 days after the last dose of study drug.
•Male subjects must be willing not to donate sperm until 90 days following the last study drug administration.
•Willing to take off dentures or mouth piercing at the time of dosing.

排除标准

•History of significant medical illness
•Clinically significant abnormalities on screening tests/exams
•History of or significant risk of committing suicide
•Donation of plasma within 7 days prior to dosing
•Donation or significant loss of blood within 8 weeks prior to the first dosing
•Major surgery within 3 months or minor surgery within 1 month prior to admission
•Use of prohibited prescription, over-the-counter medications or natural health products
•Female subjects who are currently pregnant or lactating
•Positive pregnancy test
•Positive urine drug screen, urine cotinine test, or alcohol breath test
•Use of tobacco or nicotine products within 1 month prior to Screening
•Significant alcohol consumption
•History of drug abuse within the previous year, or a positive drug screen
•History of allergy to study medications
•Part 1 only: Presence of orthodontic braces or orthodontic retention wires
•Recent participation in a clinical research study
•Not suitable for study in the opinion of the Principal Investigator

研究组 & 干预措施

Part 1

Experimental

ecopipam 89.6 mg on Days 1 and 9 with repeat doses of itraconazole Days 6-16.

干预措施: Itraconazole (Drug)

Part 1

Experimental

ecopipam 89.6 mg on Days 1 and 9 with repeat doses of itraconazole Days 6-16.

干预措施: Ecopipam (Drug)

Part 2

Experimental

ecopipam 179.2 mg on Days 1 and 13 with repeat doses of rifampicin days 6-20.

干预措施: rifampicin (Drug)

Part 2

Experimental

ecopipam 179.2 mg on Days 1 and 13 with repeat doses of rifampicin days 6-20.

干预措施: Ecopipam (Drug)