A Randomized, Double-blind, Placebo-controlled, Ascending Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VTP-43742 in Healthy Volunteers and Proof-of-Concept in Psoriatic Patients

Vitae Pharmaceuticals Inc., an Allergan affiliate1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2015年8月1日最近更新: 2018年10月30日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 40
试验地点: 1
主要终点: Number of participants with treatment-emergent adverse events (TEAEs) in the healthy volunteer (Part 1) group

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 Part 1 of a two-part, randomized, double-blind, placebo-controlled study in which VTP-43742 was administered to participants; Part 1 in healthy volunteers and Part 2 in psoriatic participants.

详细描述

This was a prospective, randomized, double-blind, placebo-controlled, ascending multiple dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics effects of VTP-43742 in healthy volunteers conducted at a single, study center in the United States (Part 1). A total of 74 participants were enrolled both parts of the study (Part 1 with 40 healthy subjects; Part 2 with 34 psoriatic participants). This post includes data from Part 1 of the study only; Part 2 is reported separately.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Factorial
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy males or females, 18 to 45 years of age, inclusive.
•Body weight of at least 55 kg and body mass index of 18-32 kg/m2, inclusive.
•Medically healthy with clinically insignificant screening results.
•Women of child-bearing potential (WOCBP) AND men with partners who are WOCBP must agree that they and/or their partner will use two reliable forms of contraception as per study requirements
•WOCBP must have a negative serum β-hCG pregnancy test at the Screening and Baseline visit.
•Voluntarily consent to participate in the trial

排除标准

•Unwilling or unable to provide written informed consent
•History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, coagulation, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
•Evidence of organ dysfunction or any clinically significant deviation from normal in vital signs, physical examination, clinical laboratory determinations or ECG
•Any major surgery within 3 months of Screening
•Positive urine drug/alcohol testing at Screening or Baseline visit
•Use of tobacco and/or nicotine-containing products within 3 months prior to the start of dosing of the trial
•Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV Ab) at Screening
•History or presence of alcoholism or drug abuse as defined in DSM V, Diagnostic Criteria for Drug and Alcohol Abuse
•History of hypersensitivity or idiosyncratic reaction to drugs from multiple drug classes
•Any previous gastrointestinal surgery or recent (within 3 months) history of gastrointestinal disease that could impact the absorption of the study drug
•Blood donation or significant blood loss within 8 weeks prior to Day 1 of the trial
•Plasma donation within 7 days prior to Day 1 of the trial
•Blood transfusion within 4 weeks of Screening
•Positive serum pregnancy test (WOCBP) at the Screening or Baseline visit
•Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical disease (e.g., infectious disease) must not be enrolled into this study
•Any other medical, psychiatric, and/or social reason as determined by the Investigator

研究组 & 干预措施

Placebo

Placebo Comparator

Dose-matched placebo administered as oral capsule(s) once daily

干预措施: Placebo (Drug)