NL-OMON51584尚未招募不适用
Phase 1 open-label, crossover study to evaluate the effect of food on the pharmacokinetics and safety of a single oral dose of PTC518 in healthy volunteers. - PTC518 food effect study.
PTC Theraputics, Inc.0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
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 64（—）
入选标准
- •1. Subjects must understand the nature of the study and must provide signed and
- •dated written informed consent before the conduct of any study-related
- •procedures and comply with all protocol requirements.
- •2. Sex: Male or female
- •3. Age: 18 to 65 years, inclusive, at Screening.
- •4. Body mass index (BMI): >=18.0 to 30.0 kg/m2 with a body weight >=50.0 kg for
- •male subjects and a body weight >=45.0 kg for female subjects at Screening.
- •5. Healthy as determined by the investigator or designee, based upon a medical
- •evaluation including medical history, physical examination, laboratory test
- •results, ECG recording (eg, a corrected QT interval using Fridericia*s formula
- •[QTcF] <=450 msec for males and QTcF <=470 msec for females), and vital signs at
- •Screening. Out-of-range values can be repeated once.
- •Further criteria apply, see protocol.
排除标准
- •1. Employee of PRA Health Sciences (PRA) or PTC.
- •2. History of hypersensitivity reactions to any excipients in the study drug
- •and/or food allergies.
- •3. History of malignancy within 5 years, unless one of the following, treated
- •and considered cured: basal cell carcinoma, in situ cervical cancer, or breast
- •ductal carcinoma in situ.
- •4. Previously randomized in this clinical trial.
- •5. Veins unsuitable for repeated venipuncture or for cannulation.
- •Further criteria apply, see protocol.
研究者
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