TS-172の健康成人を対象としたQT/QTc評価試験

試験ID jRCT2071240113

最終情報更新日：2025年2月19日

基本情報

• 試験ID: jRCT2071240113
• 研究名称 / Scientific Title（Acronym）: TS-172の健康成人を対象としたQT/QTc評価試験
• 研究名称 / Scientific Title（Acronym）: A QT/QTc evaluation study of TS-172 in healthy adult subjects
• 平易な研究名称 / Public Title（Acronym）: A QT/QTc evaluation study of TS-172 in healthy adult subjects
• 試験進捗状況/Recruitment status: 募集前
• 試験進捗状況/Recruitment status: Pending
• 登録日時: 2025年2月17日
• 最終情報更新日: 2025年2月19日

試験概要

• 試験実施地域 / Region: 日本
• 実施都道府県: 福岡県
• 目標症例数/Target sample size: 52
• 対象疾患 / Health condition(s) or Problem(s) studied: 高リン血症
• 対象疾患 / Health condition(s) or Problem(s) studied: Hyperphosphatemia
• 試験のタイプ / Study type: 介入
• 試験のタイプ / Study type: Interventional
• 介入1: TS-172 20 mg、TS-172 90 mg、モキシフロキサシン 400 mg又はプラセボを各期1日1回絶食下投与
• 主要評価項目 / Primary outcomes: QTcF（Holter 心電図検査での、Fridericia 補正法を用いて補正したQT 間隔）
• 主要評価項目 / Primary outcomes: QTcF:QT-interval corrected by Fridericia corrections in Holter ECGs

適格性

• 年齢（下限）/ Age minimum: 18歳以上
• 年齢（下限）/ Age minimum: >= 18age old
• 年齢（上限）/ Age maximum: 40歳未満
• 年齢（上限）/ Age maximum: < 40age old
• 性別 / Gender: 男女両方
• 性別 / Gender: Both

選択基準 / Include criteria

1. Japanese healthy subjects aged =>18 and <40 years at the time of obtaining informed consent
2. Subjects whose body weight is >=40 kg at the screening test, and body mass index is >=18.5 and <25.0
3. Subjects with both heart rates are =>45 and =<100 beats/min on a standard 12-lead electrocardiogram at the screening test and before drug administration in Period 1

除外基準 / Exclude criteria

1. Subjects with a history of hypersensitivity to moxifloxacin or other quinolone antibiotics
2. Subjects with a family history or risk factors for aortic aneurysm or aortic dissection (e.g., Marfan syndrome)
3. Subjects with a family history of sudden death
4. Subjects with congenital diseases, heart diseases, or medical history of such conditions
5. Subjects with risk factors for Torsades de Pointes (TdP) (e.g., heart failure, hypokalemia, or a family history of long QT syndrome) or medical history of such conditions
6. Subjects with medical history of syncope suspected to be related to TdP, unexplained syncope, or seizures
7. Subjects with standard 12-lead electrocardiogram waveforms that make it difficult to evaluate QTc prolongation (e.g., drift, EMG interference, T wave morphology, significant sinus arrhythmia, or frequent ectopic beats) at the screening and before the administration of the study drug in Period 1
8. Subjects with a QTcF (QT interval corrected using Fridericia's formula) of =>450 msec in the standard 12-lead ECG test at the screening and before the administration of the study drug in Period 1

責任研究者

• 責任研究者 / Name of lead principal investigator: Seiji Mita
• 部署名 / Division: Taisho Pharmaceutical Co., LTD.
• 住所 / Address: 3-24,1, Takada, Toshima-Ku, Tokyo Tokyo Japan 170-8633
• 電話 / Telephone: [phone]
• 実施責任組織 / Affiliation: 美田 誠二
• 実施責任組織 / Affiliation: Taisho Pharmaceutical Co., LTD.

試験問い合わせ窓口

• 住所 / Address: 3-24,1, Takada, Toshima-Ku, Tokyo Tokyo Japan 170-8633
• 電話 / Telephone: [phone]
• E-mail: [e-mail]
• 担当者 / Name of contact person: Development Management Development Headquarters