NL-OMON34941已完成2 期
Phase 2a, Double-Blind, Placebo-Controlled, 2-Period, 2-Treatment, Crossover Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Multiple Oral Doses of XPF-001 (400 mg bid) in Patients with Inherited Erythromelalgia - XPF-001-202
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Subjects will include males and females 18 - 75 years of age (inclusive), with a BMI between 19.5 and 34.0 kg/m2 (inclusive) who have a clinical diagnosis of Inherited Erythromelalgia (IEM)and an identified SCN9A gene mutation.
- •Subjects must (either spontaneously, or using one of the protocol-defined pain induction methods) achieve pain scores of
- •NRS greater or equal to 4, and/or moderate/severe on the CRS, or an intolerable level of pain irrespective of pain scores. Subjects with pain scores lower than 4/moderate will be included at the PI*s discretion, if he believes they will be able to distinguish a change in their level of pain following dosing.
- •Subjects must be willing to comply with all study procedures, including the stopping use of all medication, including those for pain management between Check-in and Discharge;
- •Subjects must be in general good health and have no contraindications to the study drug, its ingredients, or the permitted rescue medication.
排除标准
- •Subjects with a coexistent source of pain from other conditions that may interfere with the study interpretation;
- •History or evidence of any condition that, in the opinion of the PI, may pose undue risk to the subject;
- •Patients with active HIV, Hepatitis C or Hepatitis B, or currently taking medications for any of these conditions;
- •Use of any prescription or over the counter (OTC) medication or supplement from Check-in until Discharge (except for rescue medication);
- •Receiving professional psychological support specifically for coping with IEM;
- •Treatment for significant depression within the 6 months prior to Screening;
- •Females who are pregnant, lactating, or who test positive on a serum-based pregnancy test at Screening or Check-in;
- •Not currently undertaking adequate measures to prevent a pregnancy throughout the entire study;
- •Findings in laboratory data, ECG, vital signs or on physical examination at Screening or Check-in that in the opinion of the PI, may pose undue risk to the subject;
- •History or presence of alcoholism or alcohol or substance abuse (not including nicotine or caffeine);
- •Presence or history of major psychiatric disturbance and/or substance abuse, or a positive urine drug test at Check-in;
- •Ingestion of any caffeine-containing food or beverages (including chocolate) in excess of the permitted 1 cup of caffeine containing beverage per day, between Day -1 until Discharge;
- •Consumption of alcohol from Check-in until Discharge, or a positive alcohol breath test on Check-in;
- •Consumption of grapefruit or grapefruit containing products within 7 days of Day 1 until Discharge;
- •Smoking more than 3 cigarettes per day (or the equivalent in tobacco or nicotine substitutes) within the 1 week prior to ICheck-in, and the inability to refrain from all nicotine use between Check-in and Discharge;
- •Has taken an investigational drug within the 60 days prior to Day 1;
- •Donation or loss of whole blood or plasma (excluding the volume of blood that will be drawn during the Screening procedures of this study) prior to Day 1 as follows: 50 mL to 499 mL within 30 days, or more than 499 mL within 56 days prior to drug administration;
- •Has previously been enrolled into this study;
- •Study site or Sponsor employee or relative of an employee who is directly involved in the study;
- •Any other reason that would make the subject, in the opinion of the PI or Sponsor, unsuitable for the study.
研究者
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