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A Study of LY2140023 in Healthy Participants

2021年8月25日 更新者:Denovo Biopharma LLC

An Absolute Bioavailability Study of LY2140023 and LY404039 in Healthy Subjects Using the Intravenous Tracer Method

The purpose of this study is to assess the extent and rate of absorption of LY2140023 in healthy participants. The study has two periods. In Treatment Period 1, participants will receive a single oral dose of 80 milligrams (mg) LY2140023 followed by a 2-hour intravenous (IV) infusion of approximately 100 micrograms (µg) LY2140023 containing approximately 100 nanocuries (nCi) [14C]-LY2140023. In Treatment Period 2, participants will receive an oral dose of 80 mg LY2140023 followed by a 2-hour IV infusion of approximately 100 µg LY404039 containing approximately 100 nCi [14C]-LY404039. There will be at least a 3-day washout between doses.

調査の概要

研究の種類

介入

入学 (実際)

18

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

    • West Yorkshire
      • Leeds、West Yorkshire、イギリス、LS2 9LH
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

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~65年 (大人、高齢者)

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:

  • Are healthy males or females of non-childbearing potential, as determined by medical history and physical examination
  • Male participants: must agree to use a reliable method of birth control during the study and for 3 months following the last dose of LY2140023, and agree not to donate sperm for 3 months following the last dose of LY2140023
  • Female participants of non-childbearing potential i.e. postmenopausal or permanently sterile following hysterectomy, bilateral salpingectomy or confirmed tubal occlusion (not tubal ligation). Postmenopausal is defined as spontaneous amenorrhea for at least 12 months and a plasma follicle-stimulating hormone (FSH) level >40 million international units/milliliter (mIU/mL), unless the participant is taking hormone replacement therapy
  • Have given written informed consent approved by Lilly and the chosen ethical review board (ERB)
  • Have venous access sufficient to allow for intravenous infusion and blood sampling

Exclusion Criteria:

  • Are currently enrolled in or have completed or discontinued within the last 90 days from a clinical trial involving an investigational product other than the investigational product used in this study; or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
  • Have participated in any clinical trial involving a radiolabeled investigational product or been exposed to radiolabeled substances (for treatment or diagnosis) within the last 12 months
  • Have known allergies to LY2140023 or LY404039, related compounds, or any components of the formulation
  • Are persons who have previously withdrawn from this study or any other study investigating LY2140023 after receiving at least 1 dose of LY2140023
  • Show evidence or any history of significant active neuropsychiatric disease (for example, manic depressive illness, schizophrenia, depression)
  • Have increased risk of seizures based on a history of:

    • One or more seizures (except for a single simple febrile seizure [lacking focality, lasting less than 15 minutes, and not associated with a central nervous system (CNS) infection or severe metabolic disturbance] as a child between ages 6 months to 5 years)
    • Head trauma with loss of consciousness or a post-concussive syndrome within 1 year or lifetime history of head trauma with persistent neurological deficit (focal or diffuse)
    • CNS infection, uncontrolled migraine, or transient ischemic attack (TIA) within 1 year; stroke with persistent neurological deficit (focal or diffuse), uncontrolled migraine is defined as migraine attacks that produce headache lasting up to 72 hours and are often accompanied by associated symptoms (nausea, photophobia, and phonophobia) that impair well-being and disrupt social functioning. TIA is defined as a "mini-stroke" caused by temporary disturbance of blood supply to an area of the brain, which results in a sudden, brief decrease in brain function
    • CNS infection with persistent neurological deficit (focal or diffuse)
    • Brain surgery
    • Electroencephalogram (EEG) with paroxysmal (epileptiform) activity (isolated spikes waves, repetitive bursts of sharp waves, paroxysmal activity, frank seizures, spike-wave complexes, or sharp-slow wave complexes, or as locally defined)
    • Brain structural lesion, including developmental abnormalities, as determined by examination or imaging studies (except hydrocephalus treated by shunt and without neurological deficit)
  • Show evidence of active renal disease (for example, diabetic renal disease, polycystic kidney disease) or creatinine clearance less than 80 milliliters/minute (mL/min) as determined by the Cockroft Gault formula
  • Show evidence or any history of known substance dependence or abuse at any time (according to Diagnostic and Statistical Manual of Mental Disorders [DSM-IV] diagnosis), or regularly use known drugs of abuse and/or show positive findings on urinary drug screening
  • Have a clinically significant abnormality in the neurological examination
  • Participants judged prior to randomization to be at suicidal risk by the investigator

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:基礎科学
  • 割り当て:非ランダム化
  • 介入モデル:クロスオーバー割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:LY2140023 + [14C]-LY2140023
Treatment Period 1: On Day 1, a single oral dose of 80 milligrams (mg) LY2140023 (parent compound) followed by a single 2-hour intravenous (IV) infusion of approximately 100 micrograms (µg) LY2140023 containing approximately 100 nanocuries (nCi) [14C]-LY2140023.
経口投与。
Administered IV.
実験的:LY2140023 + [14C]-LY404039
Treatment Period 2: On Day 1, a single oral dose of 80 mg LY2140023 (parent compound) followed by a single 2-hour IV infusion of approximately 100 µg LY404039 containing approximately 100 nCi [14C]-LY404039 (active metabolite).
経口投与。
Administered IV.

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
メジャーの説明
時間枠
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY2140023 and LY404039 in Treatment Period 1
時間枠:Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16 and 24 hours postdose
Exposure of LY2140023 (parent compound), LY404039 (active metabolite), 14C-radiolabeled LY2140023, and 14C-radiolabeled LY404039 in terms of Area Under the Concentration Versus Time Curve from time 0 extrapolated to infinity (AUC[0-inf]) is summarized for participants in Treatment Period 1.
Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16 and 24 hours postdose
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY2140023 and LY404039 in Treatment Period 2
時間枠:Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16 and 24 hours postdose
Exposure of LY2140023 (parent compound), LY404039 (active metabolite), and 14C-radiolabeled LY404039 in terms of Area Under the Concentration Versus Time Curve from time 0 extrapolated to infinity (AUC[0-inf]) is summarized for participants in Treatment Period 2.
Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16 and 24 hours postdose

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

2012年7月1日

一次修了 (実際)

2012年7月1日

研究の完了 (実際)

2012年7月1日

試験登録日

最初に提出

2012年6月28日

QC基準を満たした最初の提出物

2012年7月2日

最初の投稿 (見積もり)

2012年7月11日

学習記録の更新

投稿された最後の更新 (実際)

2021年9月21日

QC基準を満たした最後の更新が送信されました

2021年8月25日

最終確認日

2012年8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

  • 12682
  • H8Y-MC-HBCU (その他の識別子:Eli Lilly and Company)

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。

LY2140023の臨床試験

3
購読する