A Study of LY2951742 in Healthy Volunteers
2018年10月8日 更新者:Eli Lilly and Company
A Safety, Tolerability, and Pharmacokinetic Study of Single, Escalating Subcutaneous Doses of LY2951742 in Healthy Volunteers
To evaluate the safety and tolerability of LY2951742 given as single or multiple subcutaneous injection in healthy male subjects
調査の概要
研究の種類
介入
入学 (実際)
63
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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Leuven、ベルギー
- 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
18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
男
説明
Inclusion Criteria:
- Are healthy Caucasian males, as determined by medical history and physical examination
- Agree to use a reliable method of birth control (e.g. condom AND additional contraception method to be used by respective partner) during the study and for 3 months following the last dose of the investigational product
- Have a body mass index (BMI) greater than 19 kilogram/square meter (kg/m^2)
- Have clinical laboratory test results within normal reference range for the population or investigator site
- Have venous access sufficient to allow for blood sampling
- Are willing to follow study procedures including no drugs (exception of study drug) 72 hours prior to initiation of the laser doppler imaging (LDI) procedure, no chocolate, alcohol or caffeine containing products 12 hours prior to initiation of the laser doppler imaging (LDI) procedure, and complete a 4 hour fast prior to initiation of the laser doppler imaging (LDI) procedure
- Have suitable skin characteristics for the dermal capsaicin challenge and have demonstrated a 100 percent increase in dermal flow following capsaicin challenge as part of the screening procedures and measured by laser doppler imaging (LDI)
Exclusion Criteria:
- Are currently enrolled in, have completed or discontinued within the last 30 days from, a clinical trial involving an investigational product; or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Are persons who have previously received the investigational product in this study, have completed or withdrawn from this study investigating LY2951742
- Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study including QTc greater than 450 milliseconds (msec) (male), history of congenital long QT syndrome or other conduction abnormality
- Have abnormal vital signs as determined by the investigator
- Have a history or presence of significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders (including migraine) that would constitute a risk when taking the study medication; or of interfering with the interpretation of data study
- Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Show evidence of:
- Human immunodeficiency virus infection and/or positive human immunodeficiency virus (HIV) antibodies
- Hepatitis C and/or positive hepatitis C antibody
- Hepatitis B and/or positive hepatitis B surface antigen
- Intend to use over-the-counter or prescription medication that may interfere with study safety assessments or other measurements within 7 days prior to dosing and during the study (example: systemic glucocorticoids, immunomodulatory drugs, drugs with propensity for dermal reactions, and drugs with known liver toxicity).
- Have donated blood of more than 500 milliliter (mL) or has undergone major surgery
- The use of caffeine containing products and alcohol is not allowed from 12 hours prior to all study visits and during in clinic stays. All other times, alcohol consumption and caffeine intake are limited to no more than 2 alcoholic beverages or equivalent (beer [284 mL/10 ounces], wine [125 mL/4 ounces], or distilled spirits (25 milliliter [mL/1 ounce]) per day and caffeinated beverages will be limited to no more than 2 units per day amounts (1 unit=120 milligrams [mg] of caffeine). Strenuous activity is not allowed from 1 week prior to admission until the follow-up visit.
- Are smokers within the previous 6 months
- Have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer)prior to dosing or have received a vaccination within 1 month
- Have a history of multiple or severe allergies or has had an anaphylactic reaction or intolerability to prescription or non-prescription drugs or food
- Are immunocompromised
- Have had cancer or within the past 5 years
- Have a history of significant allergies, in particular to ethanol or sensitivity to the fruits of capsicum plants (example: chili peppers)
- Have eczema, scleroderma, psoriasis, dermatitis, keloids, tumors, ulcers, burns, flaps, or grafts on their forearm or other abnormality of the skin which may interfere with the study assessments
- Cannot avoid excess tanning (any exposure to sunlight or a tanning bed which would cause a sunburn reaction) throughout the study and cannot cover forearms for 24 hours prior to treatment period
- Have excessive hair growth on the volar surface of the forearm or subjects currently using lotions, oils, depilatory preparations, or other topical treatments on a regular basis which cannot be discontinued for the duration of the study; subject has used any topical treatments within 7 days of the start of the study
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: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:Single dose 1 milligram (mg) LY2951742
Administered single subcutaneous injection
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Administered subcutaneously
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実験的:Single dose 5 mg LY2951742
Administered single subcutaneous injection
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Administered subcutaneously
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実験的:Single dose 25 mg LY2951742
Administered single subcutaneous injection
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Administered subcutaneously
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実験的:Single dose 75 mg LY2951742
Administered single subcutaneous injection
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Administered subcutaneously
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実験的:Single dose 200 mg LY2951742
Administered single subcutaneous injection
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Administered subcutaneously
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実験的:Single dose 600 mg LY2951742
Administered single subcutaneous injection
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Administered subcutaneously
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プラセボコンパレーター:Single dose placebo
Administered single subcutaneous injection
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皮下投与
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プラセボコンパレーター:Multiple dose placebo
Administered subcutaneously every 2 weeks for 6 weeks (4 doses)
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皮下投与
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実験的:150 mg LY2951742
Administered subcutaneously every 2 weeks for 6 weeks (4 doses)
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Administered subcutaneously
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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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Number of Participants With Clinically Significant Effects
時間枠:Baseline up to 6 months (study completion)
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Clinically significant effects were defined as serious and other non-serious adverse events (AEs).
A summary of serious and all other non-serious AEs is located in the Reported Adverse Events module.
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Baseline up to 6 months (study completion)
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Single Dose Pharmacokinetics of LY2951742 Maximal Concentration (Cmax)
時間枠:Day 1 up to Day 84 or early discontinuation
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Day 1 up to Day 84 or early discontinuation
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Single Dose Pharmacokinetics of LY2951742 Area Under the Curve (AUC)
時間枠:Day 1 up to Day 84 or early discontinuation
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Day 1 up to Day 84 or early discontinuation
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Multiple Dose Pharmacokinetics of LY2951742 Maximal Concentration (Cmax)
時間枠:Day 43 up to Day 57
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Day 43 up to Day 57
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Multiple Dose Pharmacokinetics of LY2951742 Area Under the Curve (AUC)
時間枠:Day 43 up to Day 57
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Day 43 up to Day 57
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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
2011年4月1日
一次修了 (実際)
2012年4月1日
研究の完了 (実際)
2012年4月1日
試験登録日
最初に提出
2011年4月15日
QC基準を満たした最初の提出物
2011年4月15日
最初の投稿 (見積もり)
2011年4月19日
学習記録の更新
投稿された最後の更新 (実際)
2019年2月20日
QC基準を満たした最後の更新が送信されました
2018年10月8日
最終確認日
2012年5月1日
詳しくは
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。