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Phase 1 Study of TAK-831 in Healthy Adult Asian Subjects

2021年6月9日 更新者：Neurocrine Biosciences

Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of TAK 831 in Healthy Adult Asian Subjects

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-831 when administered as single or multiple oral doses in healthy adult Asian participants.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

The drug being tested in this study is called TAK-831. This study will assess the safety, tolerability, pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-831 when administered as single or multiple oral doses in healthy adult Asian participants (Japanese and Chinese participants).

The study will enroll approximately 40 participants and include up to 5 cohorts of healthy adult Japanese or Chinese participants as following (8 participants per a cohort). Cohorts 3, 4 and 5 are optional and will be decided to run based on the data of Cohorts 1 and 2. Dose level for these cohorts will be defined based on the result of Cohort 1 or Cohort 2.

  • Japanese Cohort 1-A; TAK-831 100 mg single dose + TAK-831 300 mg single dose
  • Japanese Cohort 1-B; TAK-831 100 mg single dose + Placebo single dose
  • Japanese Cohort 1-C; Placebo single dose + TAK-831 300 mg single dose
  • Japanese Cohort 2; TAK-831 300 mg or TAK-831 matching placebo, single dose + TAK-831 300 mg or TAK-831 matching placebo, multiple dose *
  • Chinese Cohort 3; TAK-831 600 mg or TAK-831 matching placebo, single dose + TAK-831 600 mg or TAK-831 matching placebo, multiple dose
  • Japanese Cohort 4; TAK-831 600 mg or TAK-831 matching placebo, single dose + TAK-831 600 mg or TAK-831 matching placebo, multiple dose
  • Japanese Cohort 5; TAK-831 50 mg or TAK-831 matching placebo, single dose + TAK-831 50 mg or TAK-831 matching placebo, multiple dose *The dose in Cohort 2 will be adjusted based on the safety and tolerability as well as PK and PD in Cohort 1.

Above all treatment, randomization information will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need) and TAK-831 will be administered orally.

This single center trial will be conducted in Japan. The overall time to participate in Cohort 1 of this study is approximately 12 days and 19 days in Cohorts 2 to 5. 11 days (for Cohort 1) or 12 days (for Cohorts 2 to 5) after last dose of study drug, participants will be contacted by telephone for a follow-up assessment unless abnormal, clinically significant findings are observed upon discharge.

研究の種類

介入

入学 (実際)

40

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

  • 日本
    • Tokyo
      • Shinjuku-ku、Tokyo、日本
        • Clinical Research Hospital Tokyo

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

20年～55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. The participant must understand the study procedures and agree to participate by providing written informed consent (for Chinese participants, an interpreter should be present as necessary).
  2. The participant must be willing and able to comply with all study procedures and restrictions.
  3. The participant must be male or female (of nonchildbearing potential) aged 20 to 55 years, inclusive, at the Screening.
  4. The participant must have a body mass index (BMI) >=18.5 kg/m^2 and =<25.0 kg/m^2 at the Screening.
  5. The participant must be a current nonsmoker who has not used tobacco- or nicotine-containing products (e.g., nicotine patch) for at least 6 months prior to the Screening.
  6. Chinese participants are defined as participants who were born in mainland China, and their biological parents and grandparents must all have been of Chinese origin (for Cohort 3 only).
  7. Chinese participants who have lived out of China for more than 5 years must not have significantly modified their diets since leaving China (for Cohort 3 only).
  8. The participant must be judged to be in good health by the investigator, based on clinical evaluations including laboratory tests, medical history, full physical examination, 12-lead electrocardiogram, and vital sign measurements performed at the Screening and prior to the first dose of study drug.
  9. The participant must meet the birth control requirements.

Exclusion Criteria:

  1. The participant has a history of clinically significant endocrine, gastrointestinal (including motility disorder and intestinal obstruction), cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary, or presents with major neurological (including stroke and chronic seizures) abnormalities or diseases.
  2. The participant has participated in another investigational trial within 4 weeks before the pretrial visit (Screening). The 4-week window will be derived from the date of the last trial procedure and/or adverse event (AE) related to the trial procedure in the previous trial to the Screening Visit of the current trial.
  3. The participant is an employee or immediate family member (e.g., spouse, parent, child, sibling) of the sponsor.
  4. The participant has a history of cancer (malignancy).
  5. The participant has a history of significant multiple and/or severe allergies (e.g., food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food.
  6. The participant has a positive alcohol or drug or immunological screen.
  7. The participant is of childbearing potential or lactating.
  8. The participant had major surgery, received or lost 1 unit of blood (approximately 500 milliliters [mL]) within 8 weeks prior to the first dose of study drug.
  9. The participant with any gastrointestinal (GI) surgery that could impact upon the absorption of study drug.
  10. The participant has a known hypersensitivity to any component of the formulation of TAK-831 or related compounds.
  11. The participant is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies, beginning approximately 7 days before administration of the initial dose of trial drug, throughout the trial (including washout intervals between trial periods), until the Follow-up Visit.
  12. The participant has a history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to: beer [354 mL/12 ounces], wine [118 mL/4 ounces], or distilled spirits [29.5 mL/1 ounce] per day).
  13. The participant who consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.
  14. The participant has a history of drug abuse.
  15. The participant has a (QT interval with Fridericia's correction method) QTcF >450 milliseconds (msec) (males) or >470 msec (females) or PR outside the range of 120 to 220 msec at the Screening Visit or Check-in.

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：順次割り当て
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的：Japanese Cohort 1-A; TAK-831 100 mg + TAK-831 300 mg
TAK-831 100 milligrams (mg), tablets, orally, once daily on Day 1, followed by TAK-831 300 mg, tablets, orally, once daily on Day 9 in healthy Japanese participants.
薬：TAK-831
TAK-831 Tablets.
実験的：Japanese Cohort 1-B; TAK-831 100 mg + Placebo
TAK-831 100 mg, tablets, orally, once daily on Day 1 followed by TAK-831 matching placebo, tablets, orally, once daily on Day 9 in healthy Japanese participants.
薬：TAK-831
TAK-831 Tablets.
薬：Placebo
TAK-831 Matching Placebo Tablets.
実験的：Japanese Cohort 1-C; Placebo + TAK-831 300 mg
TAK-831 matching placebo, tablets, orally, once daily on Day 1 followed by TAK-831 300 mg, tablets, orally, once daily on Day 9 in healthy Japanese participants.
薬：TAK-831
TAK-831 Tablets.
薬：Placebo
TAK-831 Matching Placebo Tablets.
実験的：Japanese Cohort 2; TAK-831 300 mg
TAK-831 300 mg or TAK-831 matching placebo, tablets, orally, once daily on Day 1 followed by TAK-831 300 mg or TAK-831 matching placebo, tablets, orally, once daily from Day 4 to Day 17 in healthy Japanese participants.
薬：TAK-831
TAK-831 Tablets.
薬：Placebo
TAK-831 Matching Placebo Tablets.
実験的：Chinese Cohort 3; TAK-831 600 mg
TAK-831 600 mg or TAK-831 matching placebo, tablets, orally, once daily on Day 1 followed by TAK-831 600 mg or TAK-831 matching placebo, tablets, orally, once daily from Day 4 to Day 17 in healthy Chinese participants. This cohort is optional and will be decided to run based on the data of Cohorts 1 and 2. The dose will be defined based on the result of Cohort 1 or Cohort 2.
薬：TAK-831
TAK-831 Tablets.
薬：Placebo
TAK-831 Matching Placebo Tablets.
実験的：Japanese Cohort 4; TAK-831 600 mg
TAK-831 600 mg or TAK-831 matching placebo, tablets, orally, once daily on Day 1 followed by TAK-831 600 mg or TAK-831 matching placebo, tablets, orally, once daily from Day 4 to Day 17 in healthy Japanese participants. This cohort is optional and will be decided to run based on the data of Cohorts 1 and 2. The dose will be defined based on the result of Cohort 1 or Cohort 2.
薬：TAK-831
TAK-831 Tablets.
薬：Placebo
TAK-831 Matching Placebo Tablets.
実験的：Japanese Cohort 5; TAK-831
TAK-831 50 mg or TAK-831 matching placebo, tablets, orally, once daily on Day 1 followed by TAK-831 50 mg or TAK-831 matching placebo, tablets, orally, once daily from Day 4 to Day 17 in healthy Japanese participants.
薬：TAK-831
TAK-831 Tablets.
薬：Placebo
TAK-831 Matching Placebo 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
Number of Participants Reporting at Least One Treatment-emergent Adverse Event (TEAE)
時間枠：Cohort 1: Baseline up to Day 23; Cohorts 2-5: Baseline up to Day 31
Cohort 1: Baseline up to Day 23; Cohorts 2-5: Baseline up to Day 31
Number of Participants Reporting at Least One TEAE Related to Laboratory Test Results
時間枠：Cohort 1: Baseline up to Day 23; Cohorts 2-5: Baseline up to Day 31
Cohort 1: Baseline up to Day 23; Cohorts 2-5: Baseline up to Day 31
Number of Participants Reporting at Least One TEAE Related to Vital Sign
時間枠：Cohort 1: Baseline up to Day 23; Cohorts 2-5: Baseline up to Day 31
Cohort 1: Baseline up to Day 23; Cohorts 2-5: Baseline up to Day 31
Number of Participants Reporting at Least One TEAE Related to Body Weight
時間枠：Cohort 1: Baseline up to Day 23; Cohorts 2-5: Baseline up to Day 31
Cohort 1: Baseline up to Day 23; Cohorts 2-5: Baseline up to Day 31
Number of Participants Reporting at Least One TEAE Related to 12-lead Electrocardiogram (ECG) Parameters
時間枠：Cohort 1: Baseline up to Day 23; Cohorts 2-5: Baseline up to Day 31
Cohort 1: Baseline up to Day 23; Cohorts 2-5: Baseline up to Day 31

二次結果の測定

結果測定
時間枠
Cmax: Maximum Observed Plasma Concentration for TAK-831
時間枠：Cohort 1: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose; Cohorts 2 to 5: Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose
Cohort 1: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose; Cohorts 2 to 5: Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose
Cohorts 2 to 5, Cmax, ss: Maximum Observed Steady-state Plasma Concentration During a Dosing Interval for TAK-831
時間枠：Day 17 pre-dose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post-dose
Day 17 pre-dose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-831
時間枠：Cohort 1: Day 1 pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72 hours post-dose; Cohorts 2 to 5: Day 1 pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72 hours post-dose; Day 17 pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24 hours post-dose
Cohort 1: Day 1 pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72 hours post-dose; Cohorts 2 to 5: Day 1 pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72 hours post-dose; Day 17 pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24 hours post-dose
AUClast: Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration for TAK-831
時間枠：Cohort 1: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose; Cohorts 2 to 5: Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose
Cohort 1: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose; Cohorts 2 to 5: Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831
時間枠：Cohort 1: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose; Cohorts 2 to 5: Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose
Cohort 1: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose; Cohorts 2 to 5: Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose
Cohorts 2 to 5, AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 to [Time] Over the Dosing Interval for TAK-831
時間枠：Day 1: pre-dose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose and Day 17: pre-dose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose
Day 1: pre-dose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose and Day 17: pre-dose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, and 24 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

Neurocrine Biosciences

協力者

Takeda

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)

2018年10月9日

一次修了 (実際)

2019年6月9日

研究の完了 (実際)

2019年6月19日

試験登録日

最初に提出

2018年9月26日

QC基準を満たした最初の提出物

2018年9月26日

最初の投稿 (実際)

2018年9月27日

学習記録の更新

投稿された最後の更新 (実際)

2021年6月14日

QC基準を満たした最後の更新が送信されました

2021年6月9日

最終確認日

2021年6月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • TAK-831-1002
  • U1111-1219-2623 (その他の識別子：WHO)
  • JapicCTI-184127 (レジストリ識別子：JapicCTI)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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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