临床试验/NCT03493269

NCT03493269已完成1 期

A Randomized, Double-blind, Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics and Exploratory Pharmacodynamics of Multiple Oral Doses of BAY1834845 in Healthy Male Subjects and in Female and Male Patients With Psoriasis Over an Extended Treatment Duration

Bayer2 个研究点分布在 1 个国家目标入组 72 人开始时间: 2018年4月16日最近更新: 2021年2月26日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Bayer
入组人数: 72
试验地点: 2
主要终点: Frequency of treatment-emergent adverse events (TEAEs)

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

To assess safety and tolerability of multiple oral doses of BAY1834845 in healthy male subjects (Part 1) and in patients with psoriasis (Part 2).

To assess the pharmacokinetic (PK) properties of total BAY1834845 in plasma after oral multiple doses of BAY1834845 in healthy male subjects (Part 1) and patients with psoriasis (Part 2).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
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 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Part 1 (healthy male subjects)
•Healthy male subjects, 18 to 50 years of age (inclusive), and in good health as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory tests at screening
•Body mass index (BMI) above or equal to 18.5 and lower or equal to 30 kg/m2 (BMI = body weight (kg) / [height (m)]2 and a body weight above or equal 50 kg Part 2 (patients with psoriasis)
•Male patients, 18 to 70 years of age (inclusive) or female patients of non-child bearing potential, 30 to 70 years of age (inclusive)
•Body mass index above or equal to 18.5 and lower or equal to 35 kg/m*2 and a body weight above 50 kg
•A documented diagnosis of psoriasis, with a history of at least 6 months prior to study drug administration. Moderate to severe plaque psoriasis at screening, defined by: a) an involved body surface area (BSA) above or equal to 10% of BSA, b) a Psoriasis Area and Severity Index (PASI) score of above or equal, 12 c) a Physician's Global Assessment (PGA) score of above or equal 2.

排除标准

•History of hypersensitivity to any of the components of the study drug
•Any clinically relevant abnormal findings in safety laboratory parameters and ECG
•History of tuberculosis (TB) or active or latent tuberculosis
•Receipt of live or attenuated vaccine 90 days prior to the first dosing

研究组 & 干预措施

Placebo

Placebo Comparator

Part 2: The placebo will be adminstered in female and male patients with psoriasis

干预措施: Matching Placebo (Other)

BAY1834845

Experimental

Part 1 in healthy male subjects:

Dose Groups 1-4 : orally administered multiple ascending doses. The treatment will last 10 consecutive days (treatment period1) and 1 day (treatment period 2) Dose Group 5: The treatment will last 1 day (treatment period 1) and 10 consecutive days (treatment period 2)

干预措施: BAY1834845 (Drug)

BAY1834845

Experimental

Part 1 in healthy male subjects:

干预措施: Midazolam (Drug)

Matching Placebo

Placebo Comparator

Part 1: Matching placebo in healthy male subjects.

干预措施: Matching Placebo (Other)

Matching Placebo

Placebo Comparator

Part 1: Matching placebo in healthy male subjects.

干预措施: Midazolam (Drug)

Chosen dose of BAY1834845

Experimental

Part 2: This dose level will be adminstered in female and male patients with psoriasis

干预措施: BAY1834845 (Drug)

结局指标

主要结局

Frequency of treatment-emergent adverse events (TEAEs)

时间窗: Approximately 84 days

Part 2: Patients with psoriasis

Severity of treatment-emergent adverse events (TEAEs)

时间窗: Approximately 84 days

Part 2: Patients with psoriasis

AUC(0-24)md of BAY1834845

时间窗: Part 2: one day between day 35 and 42

Part 2: AUC(0-24)md: AUC from zero to 24 hours after multiple dosing

AUC(0-12)md of BAY1834845

时间窗: Part 2: one day between day 35 and 42

Part 2: AUC(0-12)md: AUC from zero to 12 hours after multiple dosing

Cmax,md of BAY1834845

时间窗: Part 2: one day between day 35 and 42

Part 2: Cmax,md:Cmax (Maximum observed drug concentration, directly taken from analytical data) after multiple dosing

Cav, md of BAY1834845

时间窗: Part 2: one day between day 35 and 42

Part 2: Cav: Average concentration within a dosing interval after multiple dosing

Cav,md of BAY1834845

时间窗: Part 1 - Period 1 (dose group 1-4): Day 1 to 2 Part 1 - Period 2 (dose group 5): Day 1 to 2

Part 1 Cav:Average concentration within a dosing interval after multiple dosing

次要结局

未报告次要终点

研究者

发起方

Bayer

申办方类型

Industry

责任方

Sponsor

研究点 (2)

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