A phase 1 pharmacokinetic study to assess and compare the relative bioavailability of a capsule and a tablet formulation of YTX-7739 following single oral doses administered with and without food in Healthy Volunteers - YTX-7739 formulation study

Yumanity Therapeutics0 个研究点目标入组 16 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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•1. Healthy adult male or female subjects 18-55 years of age, inclusive; defined
•as absence of evidence of any active acute or chronic disease or illness
•following a detailed medical and surgical history, a complete physical
•examination including vital signs, 12-lead ECG, haematology, blood chemistry
•and urinalysis;
•2. Body mass index (BMI) between 18-30 kg/m2, inclusive, and with a minimum
•weight of 50kg and maximum weight of 100kg.

•1. Clinically significant findings as determined by medical history taking,
•physical examination, ECG, laboratory findings (including lipid or hormone
•profiles) and vital signs, as judged by the investigator.
•3. Subjects with a QTcF of > 450 ms for males and > 470 ms for females at
•screening or a history of long QT syndrome.
•8. Being on a diet composed of relevantly altered amounts of fat, protein or
•carbohydrates that may affect triglyceride and fatty acid levels (such as
•high-fat, gluten-free, carbohydrate-free, protein rich diets).
•10. Gastrointestinal disease (such as irritable bowel syndrome, inflammatory
•bowel disease, chronic gastritis, peptic ulcer disease, etc.) that could affect
•absorption of the study drug.
•11 History of gastric surgery, including Roux-en-Y gastric bypass surgery, an
•antrectomy with vagotomy, or gastrectomy.

发起方

Yumanity Therapeutics