臨床研究等提出・公開システム

無作為化非盲検クロスオーバー試験

A randomized, Open-label, crossover

1.治験の内容を理解し、それを遵守する能力があると治験責任医師又は治験分担医師が判断した者
2.治験手順が行われる前に、同意・説明文書に被験者による署名及び日付記入ができる者
3.日本人の健康成人男子
4.同意取得時に20歳以上35歳以下である者
5.スクリーニング時に体重が50.0 kg以上、BMIが18.5 kg/m2以上25.0 kg/m2以下である者

1.In the opinion of the investigator or subinvestigator, the subject is capable of understanding and complying with protocol requirements.
2.The subject signs and dates a written, informed consent form prior to the initiation of any study procedures.
3.The subject is a Japanese healthy adult male.
4.The subject is aged 20 to 35 years, inclusive, at the time of informed consent.
5.The subject has a body weight of 50 kg or more with a BMI of >=18.5 kg/m2 and <25.0 kg/m2 at screening.

1.第1期の治験薬投与開始前16週（112日）以内に他の治験薬の投与を受けた者
2.過去に治験又は治療行為としてSYR-322又はメトホルミン塩酸塩の投与を受けたことがある者
3.治験実施医療機関の従業員、その家族又は本治験の実施に関わる治験実施医療機関の従業員と依存した関係にある者（例：夫婦、親、子供、兄弟姉妹）若しくは強制の下に同意するおそれがある者
4.コントロール不良かつ臨床的に問題のある神経、循環器、肺、肝、腎、代謝、消化器、泌尿器、内分泌疾患又はその他の異常を有しており、治験参加や治験結果に影響を与える可能性がある者
5.薬物に対して過敏症を有する者
6.スクリーニング時に薬物濫用（不法な薬物使用に定義される）の尿検査結果が陽性である者
7.スクリーニング時の来院前2年以内に薬物濫用若しくはアルコール依存症の既往がある者又は治験期間中、アルコール摂取若しく薬物使用をやめる意思のない者
8.併用禁止薬、ビタミン剤又は併用禁止薬及び食品の表に記載される食品が必要な者
9.現在、心血管系障害、中枢神経系障害、肝障害、造血疾患、腎不全、代謝若しくは内分泌障害、重篤なアレルギー、喘息、低酸素血症、高血圧、痙攣又はアレルギー性発疹を有する者。DPP-4阻害剤及びビグアナイド系薬剤の服薬が禁忌となる疾患又は治験実施に影響を及ぼす可能性のある疾患が疑われる病歴を有する者。診察又は臨床検査所見に異常がある者。消化性潰瘍疾患、痙攣性疾患又は不整脈等を有する者。
10.薬物の吸収に影響を及ぼす可能性のある消化器系疾患〔吸収不良、食道逆流、消化性潰瘍疾患、びらん性食道炎、週に1回以上の胸やけ又は外科的介入（胆嚢摘出等）〕を現在認める又は第1期の治験薬投与開始前24週（168日）以内に認めた者
11.癌の既往がある者
12.スクリーニング時にB型肝炎ウイルス表面抗原（HBsAg）、C型肝炎ウイルス（HCV）抗体、ヒト免疫不全ウイルス（HIV）抗原／抗体、梅毒血清反応のいずれかが陽性の者
13.末梢静脈からの採血が困難な者
14.第1期の治験薬投与開始前4週（28日）以内に200 mL以上又は第1期の治験薬投与開始前12週（84日）以内に400 mL以上の全血を採取した者
15.第1期の治験薬投与開始前52週（364日）以内に合計800 mL以上の全血を採取した者
16.第1期の治験薬投与開始前2週（14日）以内に血液成分を採取した者
17.スクリーニング時又は第1期のDay 1に実施する治験薬投与開始前の臨床検査において、ヘモグロビン量が12.5 g/dL未満である者
18.スクリーニング時又は第1期のDay 1に実施する治験薬投与開始前の12誘導心電図検査において、臨床的に問題のある心電図の異常が認められた者
19.スクリーニング時又は第1期のDay 1に実施する治験薬投与開始前の臨床検査において、臨床的に問題のある原疾患を示唆する臨床検査値の異常を認めた者又は次の項目に異常値が認められた者：正常上限の1.5倍を超えるALT又はAST
20.治験実施計画書に従う可能性の低い又はその他の理由で不適と治験責任医師又は治験分担医師が判断する者

1. The subject has received any investigational compound within 16 weeks (112 days) prior to the start of study drug administration in Period 1.
2. The subject has received SYR-322 or metformin hydrochloride in a previous clinical study or as a therapeutic agent.
3. The subject is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress.
4. The subject has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, or endocrine disease or other abnormality, which may impact the ability of the subject to participate or potentially confound the study results.
5. The subject has a known hypersensitivity to drugs.
6. The subject has a positive urine drug result for drugs of abuse (defined as any illicit drug use) at screening.
7. The subject has a history of drug abuse or history of alcohol abuse within 2 years prior to the screening visit or unwilling to agree to abstain from alcohol and drugs throughout the study.
8. Subject has taken any excluded medication, supplements, or food products during the time periods listed in the Excluded Medications and Dietary Products table.
9. Subject has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma, hypoxemia, hypertension, seizures, or allergic skin rash. There is any finding in the subject's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking DPP-4 inhibitors or biguanides, or a similar drug in the same class, or that might interfere with the conduct of the study. This includes, but is not limited to, peptic ulcer disease, seizure disorders, and cardiac arrhythmias.
10. The subject has current or recent [within 24 weeks (168 days) prior to the initiation of study treatment in Period 1] gastrointestinal disease that would be expected to influence the absorption of drugs (i.e., a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once per week] occurrence of heartburn, or any surgical intervention [e.g., cholecystectomy]).
11. The subject has a history of cancer.
12. The subject has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV), human immunodeficiency virus (HIV) antibody/antigen, or serological reactions for syphilis at screening.
13. The subject has poor peripheral venous access.
14. The subject has undergone whole blood collection of at least 200 mL within 4 weeks (28 days) or at least 400 mL within 12 weeks (84 days) prior to the start of study medication administration Period 1.
15. The subject has undergone whole blood collection of at least 800 mL in total within 52 weeks (364 days) prior to the start of study medication administration in Period 1.
16. The subject has undergone blood component collection within 2 weeks (14 days) prior to the start of study medication administration in Period 1.
17. The subject has a screening or prior to the start of study medication administration on Day 1 in Period 1 hemoglobin level <12.5 g/dl.
18. The subject has a screening or prior to the start of study medication administration on Day 1 in Period 1 abnormal (clinically significant) 12-lead ECG.
19. Subject has abnormal screening or prior to the start of study medication administration on Day 1 in Period 1 laboratory values that suggest a clinically significant underlying disease or subject with the following lab abnormalities: ALT and/or AST >1.5 the upper limits of normal.
20. Subject who, in the opinion of the investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.

20歳以上

20age old over

35歳以下

35age old under

男性

Male

試験完了

completed