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A Single- and Multiple-Dose Study of the Pharmacokinetics of TAK-491 in Healthy Chinese Participants

2020年1月28日 更新者:Takeda

A Randomized, Open-Label and Double-Blind, Placebo-Controlled, Single- and Multiple-Dose, Phase 1 Study of the Pharmacokinetics of TAK-491 40 mg and 80 mg in Healthy Chinese Subjects

The purpose of this study is to assess the pharmacokinetics and safety of single- and multiple-dose of TAK-491 in healthy Chinese participants.

調査の概要

詳細な説明

The drug being tested in this study is called TAK-491. TAK-491 is being tested to treat people who have hypertension. This study will look at the pharmacokinetics of TAK-491 in Chinese participants who take TAK-491.

The study will enroll approximately 64 participants.

The first 16 enrolled participants have been randomly assigned (by chance, like flipping a coin) to 1 of the 2 treatment groups:

  • TAK-491 40 mg
  • TAK-491 80 mg

All participants will be asked to take 1 tablet at the same time on Day 1 and Day 4 to 10 during the study.

The following 48 randomized participants will be randomly assigned (by chance, like flipping a coin) to 1 of the 3 treatment groups:

  • TAK-491 40 mg
  • TAK-491 80 mg
  • TAK-491 placebo

All participants will be asked to take two tablets at the same time on Day 1 and Day 4 to 10 during the study.

This single-center trial will be conducted in China. The overall time to participate in this study is approximately 52 days. Participants will be admitted in the clinic for the first 12 days, and will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment.

研究の種類

介入

入学 (実際)

64

段階

  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Beijing,P.R.
      • Beijing、Beijing,P.R.、中国

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~45年 (大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. Is capable of understanding and complying with protocol requirements.
  2. The participant or, when applicable, the legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
  3. Is a healthy adult male or female of Chinese descent.
  4. Is aged 18 to 45 years, inclusive, at the time of informed consent and first study medication dose.
  5. Has a body mass index (BMI) greater than or equal to (>=) 19.0 kilogram per square meter (kg/m^2) and less than (<) 24.0 kg/m^2, inclusive at Screening.
  6. Has clinical laboratory evaluations (including clinical chemistry [fasted for at least 8 hours for the screening assessment], hematology, and complete urinalysis) within the reference range for the testing laboratory, unless the results were deemed by the investigator to be not clinically significant at Screening and Check-in (Day -1).
  7. Is willing to refrain from strenuous exercise, from 72 hours before Check-in (Day-1) until after Final Visit.
  8. A female of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after the last dose of study drug.

Exclusion Criteria:

  1. Has received any investigational compound within 30 days prior to Screening.
  2. Has received TAK-491 in a previous clinical study or as a therapeutic agent.
  3. Is an immediate family member, study site employee, or in a dependant relationship with a study site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or may consent under duress.
  4. Has history of uncontrolled, clinically significant manifestations of metabolic (including diabetes mellitus, hypercholesterolemia, or dyslipidemia), endocrine, hematologic, pulmonary, cardiovascular, gastrointestinal, neurological, rheumatologic, skin and subcutaneous tissue disorders, infectious, hepatic, renal, urologic, immunologic, psychiatric or mood disorders (including any past history of suicide attempt), or a history of lactose intolerance, which may impact the ability of the participant to participate or potentially confound the study results.
  5. Has a known hypersensitivity to any component of the formulation of TAK-491 or other AII inhibitors or related compounds.
  6. Has a positive urine drug result for drugs of abuse or breath alcohol test at Screening or Check-in (Day -1).
  7. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.
  8. Has taken any excluded medication, supplements, or food products.
  9. If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 30 days after participating in this study; or intending to donate ova during such time period.
  10. Has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (that is, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis frequent [more than once per week] occurrence of heartburn, or any surgical intervention [example, cholecystectomy]).
  11. Has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1.
  12. Has positive test result for anti-Human immunodeficiency virus (HIV), anti- hepatitis C virus (HCV) antibodies, or for hepatitis B surface antigen (HBsAg) at Screening.
  13. Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in (Day -1). Cotinine test is positive at Screening or Check-in (Day -1).
  14. Has poor peripheral venous access.
  15. Has donated or lost 450 milliliter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 30 days prior to Day 1.
  16. Has a Screening or Check-in (Day -1) abnormal (clinically significant) electrocardiogram (ECG). Entry of any participants with an abnormal (not clinically significant) ECG must be approved, and documented by signature by the principal investigator.
  17. Has abnormal Screening or Check-in (Day -1) laboratory values that suggest a clinically significant underlying disease or participant with the following lab abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than (>) 1.5 times the upper limits of normal.
  18. Has a hemoglobin value <12 gram per deciliter (g/dL) at Screening.
  19. Has a systolic blood pressure <110 and >=160 millimeter of Mercury (mmHg) or a diastolic blood pressure <60 and >=100 mmHg at Screening or Check-in (Day -1).

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:他の
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的:TAK-491 40 mg (Open Label)
TAK-491 40 milligram (mg), tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
TAK-491 tablets
他の名前:
  • エダルビ
  • Azilsartan medoxomil
実験的:TAK-491 80 mg (Open-label)
TAK-491 80 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
TAK-491 tablets
他の名前:
  • エダルビ
  • Azilsartan medoxomil
実験的:TAK-491 40 mg (Double-blind)
TAK-491 40 mg, tablet, orally, once daily and TAK-491 80 mg placebo-matching tablet, orally, once daily on Day 1 and Days 4 to 10 in double-blind manner.
TAK-491 tablets
他の名前:
  • エダルビ
  • Azilsartan medoxomil
TAK-491 placebo-matching tablets
実験的:TAK-491 80 mg (Double-blind)
TAK-491 80 mg, tablet, orally, once daily and TAK-491 40 mg placebo-matching tablet, orally, once daily on Day 1 and Days 4 to 10 in double-blind manner.
TAK-491 tablets
他の名前:
  • エダルビ
  • Azilsartan medoxomil
TAK-491 placebo-matching tablets
プラセボコンパレーター:Placebo
TAK-491 40 mg placebo-matching tablet, orally, once daily and TAK-491 80 mg placebo-matching tablet, orally, once daily on Day 1 and Days 4 to 10.
TAK-491 placebo-matching tablets

この研究は何を測定していますか?

主要な結果の測定

結果測定
時間枠
Cmax: Maximum Observed Plasma Concentration for TAK-536 (the Active Moiety Derived From TAK-491) on Day 1
時間枠:Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Cmax: Maximum Observed Plasma Concentration for TAK-536 (the Active Moiety Derived From TAK-491) on Day 10
時間枠:Day 10 pre-dose and at multiple time points (up to 24 hours) post-dose
Day 10 pre-dose and at multiple time points (up to 24 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536 (the Active Moiety Derived From TAK-491) on Day 1
時間枠:Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536 (the Active Moiety Derived From TAK-491) on Day 10
時間枠:Day 10 pre-dose and at multiple time points (up to 24 hours) post-dose
Day 10 pre-dose and at multiple time points (up to 24 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-536 (the Active Moiety Derived From TAK-491) on Day 1
時間枠:Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
AUC(0-24): Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose for TAK-536 (the Active Moiety Derived From TAK-491) on Day 10
時間枠:Day 10 pre-dose and at multiple time points (up to 24 hours) post-dose
Day 10 pre-dose and at multiple time points (up to 24 hours) post-dose
Terminal Phase Elimination Half-life (T1/2) for TAK-536 (the Active Moiety Derived From TAK-491) on Day 1
時間枠:Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2015年11月20日

一次修了 (実際)

2017年3月17日

研究の完了 (実際)

2017年3月17日

試験登録日

最初に提出

2015年9月2日

QC基準を満たした最初の提出物

2015年9月2日

最初の投稿 (見積もり)

2015年9月4日

学習記録の更新

投稿された最後の更新 (実際)

2020年2月5日

QC基準を満たした最後の更新が送信されました

2020年1月28日

最終確認日

2020年1月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • TAK-491_112
  • U1111-1159-5559 (その他の識別子:WHO)

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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