A Study of LY2963016 in Healthy Participants
2014年10月3日 更新者:Eli Lilly and Company
Pharmacokinetics and Pharmacodynamics of LY2963016 Compared to Lantus® in Healthy Subjects Following Two Single Subcutaneous Doses
This study involves 2 single injections of LY2963016 and 2 single injections of Lantus. There will be at least 6 days between each injection.
The study will compare LY2963016 to Lantus at two different doses.
This study is approximately 10 weeks long, not including screening. Screening is required within 4 weeks of the start of the study.
調査の概要
研究の種類
介入
入学 (実際)
24
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
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Singapore、シンガポール、117597
- 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.
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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
21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:
- Healthy males or females
- Women must be either surgically sterile, post-menopausal, or agree to use a reliable method of birth control during the study
- Have a body mass index between 18.5 and 29.9 kilograms per meter squared (kg/m²)
- Are nonsmokers and have not smoked for at least 6 months prior to entering the study
- Have normal blood pressures and pulse rates at screening, as determined by the investigator
- Have an electrocardiogram (ECG) at screening considered as within normal limits by the investigator
- Have clinical laboratory test results within normal reference range for the population
- Have fasting plasma glucose <110 milligrams per deciliter (mg/dL) (<6.0 micromoles per liter [mmol/L]) at screening
- Have venous access sufficient to allow for blood sampling, intravenous drug administration, and clamp procedures as per the protocol
- Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site
Exclusion Criteria:
- Are persons who have previously completed or withdrawn from this study
- Are currently enrolled in or have discontinued within the last 30 days from a clinical trial involving an investigational drug or device or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Have known allergies to insulin, its excipients, or related drugs or have history of relevant allergic reactions of any origin
- Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
- Show evidence of significant active neuropsychiatric disease
- Show evidence of current use of known drugs of abuse or have a history of use within the past year
- Have a history of first-degree relatives known to have diabetes mellitus
- Show evidence of an acute infection with fever or infectious disease at the time of study entry
- Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies at screening
- Have positive hepatitis B surface antigens at screening
- Intend to use over-the-counter medication within 7 days or prescription medication within 14 days prior to dosing (apart from vitamin/mineral supplements, occasional paracetamol, thyroid replacement, or birth control methods)
- Have donated blood or had a blood loss of 450 milliliters (mL) 3 months prior to study enrollment
- Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females) or are unwilling to stop alcohol consumption from 48 hours prior to each dosing until discharged from the clinical research unit (CRU)
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: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:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:0.3 U/kg LY2963016
Single 0.3 units/kilogram (U/kg) subcutaneous dose of LY2963016
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皮下投与
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実験的:0.3 U/kg Lantus
Single 0.3 U/kg subcutaneous dose of Lantus
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皮下投与
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実験的:0.6 U/kg LY2963016
Single 0.6 U/kg subcutaneous dose of LY2963016
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皮下投与
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実験的:0.6 U/kg Lantus
Single 0.6 U/kg subcutaneous dose of Lantus
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皮下投与
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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 |
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Pharmacokinetics: Area Under the Serum LY2963016 or Lantus Concentration-Time Curve (AUC) From Zero to Infinity [AUC(0-∞)]
時間枠:Predose up to 24 hours after administration of study drug
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Results for LY2936016 treatment arms provide the AUC(0-∞) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-∞) for Lantus.
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Predose up to 24 hours after administration of study drug
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Pharmacokinetics: Maximum Serum LY2963016 or Lantus Concentration (Cmax)
時間枠:Predose up to 24 hours after administration of study drug
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Predose up to 24 hours after administration of study drug
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pharmacokinetics: Area Under the Serum Concentration-Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY2963016 or Lantus
時間枠:Predose up to 24 hours after administration of study drug
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Results for LY2936016 treatment arms provide the AUC(0-24) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-24) for Lantus.
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Predose up to 24 hours after administration of study drug
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Pharmacokinetics: Area Under the Serum Concentration-Time Curve (AUC) From Time Zero to Last Measured Concentration Value [AUC(0-tlast)] of LY2963016 or Lantus
時間枠:Predose up to 24 hours after administration of study drug
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Results for LY2936016 treatment arms provide the AUC(0-tlast) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-tlast) for Lantus.
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Predose up to 24 hours after administration of study drug
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Maximum Glucose Infusion Rate (Rmax)
時間枠:Postdose up to 24 hours after administration of study drug
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Rmax is used to measure the study drug action over time as measured by the euglycaemic clamp procedure.
During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate.
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Postdose up to 24 hours after administration of study drug
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Total Amount of Glucose Infused (Gtot)
時間枠:Postdose up to 24 hours after administration of study drug
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Gtot is used to measure the study drug action over time as measured by the euglycaemic clamp procedure.
During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate.
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Postdose up to 24 hours after administration of study drug
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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9月1日
研究の完了 (実際)
2012年9月1日
試験登録日
最初に提出
2012年7月2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6日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年10月7日
QC基準を満たした最後の更新が送信されました
2014年10月3日
最終確認日
2014年10月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 14676
- I4L-MC-ABEM (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。