Disposition of Carbon-14-Labeled LY2886721 ([^14C]-LY2886721) Following Oral Administration in Healthy Human Participants
2019年8月9日 更新者:Eli Lilly and Company
Disposition of [14C]-LY2886721 Following Oral Administration in Healthy Human Subjects
This open-label study is being conducted to determine the metabolism and physiological disposition of radiolabeled LY2886721 after a single dose in healthy male participants.
調査の概要
研究の種類
介入
入学 (実際)
6
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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Wisconsin
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Madison、Wisconsin、アメリカ
- 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~50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:
- Healthy males as determined by medical history and physical examination
- Males will be sterile (including vasectomy) or if the participant is not sterile and is sexually active, he will agree to use from check-in until 3 months after exit/discharge, 1 of the following approved methods of contraception: a male condom with spermicide, a sterile sexual partner, use by female sexual partner of an intrauterine device with spermicide, a female condom with spermicide, contraceptive sponge with spermicide, a diaphragm with spermicide, a cervical cap with spermicide, or oral, implantable, transdermal, intravaginal, or injectable contraceptives
- Have a body mass index of 19 to 30 kilograms per square meter (kg/m^2)
- Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
- Have venous access sufficient to allow for blood sampling
- Have normal blood pressure and heart rate (sitting)
- Experience a minimum of at least 1 bowel movement per day
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
- Have given written informed consent approved by Lilly and the institutional review board (IRB) governing the site
Exclusion Criteria:
- Are currently enrolled in, have completed, or discontinued within the last 30 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 known allergies to LY2886721, related compounds, or any components of the formulation
- Are persons who have previously received the investigational product in this study, have completed or withdrawn from this study or any other study investigating LY2886721
- Have a Bazett's corrected QT (QTcB) interval value of >450 milliseconds (msec) or any abnormality in the 12-lead electrocardiogram (ECG) increases the risks associated with participating in the study
- Have an abnormal blood pressure
- Have a history or presence of 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
- Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies
- Show evidence of hepatitis C and/or positive hepatitis C antibody
- Show evidence of hepatitis B and/or positive hepatitis B surface antigen
- Intend to use prescription medication, over-the-counter medication, or herbal preparations containing St. John's Wort, kava, garlic, ginger, ginko biloba, or guarana within 14 days prior to admission
- Eating of grapefruit or grapefruit-containing foods, or drinking grapefruit-containing juices within 7 days prior to dosing or any time during the study
- Have used any tobacco- or nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to dosing
- Have donated blood of more than 500 milliliters (mL) within the last month
- Have an average weekly alcohol intake that exceeds 21 units per week (males up to age 65), or are unwilling to stop alcohol consumption from 48 hours prior to check-in until end of study [1 unit = 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits]
- Show evidence of significant active neuropsychiatric disease, in particular evidence of significant medical or psychiatric illness within the past 12 months. Have any other condition that would preclude participation in the study
- Have a history or presence of epilepsy, a history of seizures, any known brain abnormalities, and a history of significant brain injury
- Have participated in a [^14C] study within the last 6 months prior to check-in for this study. The total exposure from this study and the previous study must be within the Code of Federal Regulations (CFR) recommended levels considered safe (per 21 CFR 361.1), less than 5,000 millirems (mrem)/year whole body annual exposure
- Exposure to significant radiation within 12 months prior to dose (for example, serial X-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring)
- Have a history of clinically significant adverse drug reactions or "drug allergy" to more than 3 types of systemically administered medications (all penicillins and cephalosporins may be considered 1 type of medication for this purpose)
- Have a history of, or current, significant ophthalmological disease
- Have evidence of active renal disease (for example, diabetic renal disease, polycystic kidney disease) or creatinine clearance of <80 milliliters per minute (mL/min) as calculated by Cockcroft-Gault equation: Men: (140-age)*weight in kilograms (kg)/72*[serum creatinine in milligrams per deciliter (mg/dL)]
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:なし
- 介入モデル:単一グループの割り当て
- 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 |
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実験的:Radiolabeled LY2886721
Single 25 milligram (mg) oral dose containing 80 microCuries of radiolabeled LY2886721
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Administered orally
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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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Percentage of Urinary and Fecal Excretion of LY2886721 Radioactivity Over Time
時間枠:Predose up to 7 days (168 hours) postdose
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Urinary and fecal excretion of LY2886721 radioactivity over time was expressed as a percentage of the total radioactive dose administered.
The amount of drug-related material excreted in urine and feces (Ae) at a specific collection interval (i) was calculated as the product of radioactivity concentration and volume or weight.
The Ae values for each collection interval were then summed and calculated as Total Ae=Ae(i1)+Ae(i2)+Ae(in).
The percentage of the total radiolabeled dose administered that was excreted in feces or urine=[(Total Ae)/(Total radioactive dose administered)]*100.
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Predose up to 7 days (168 hours) postdose
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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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Plasma Pharmacokinetics (PK) of LY2886721: Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0 to Inf)]
時間枠:Predose up to 4 days (96 hours) postdose
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Predose up to 4 days (96 hours) postdose
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PK of Radioactivity: AUC(0 to Inf)
時間枠:Predose up to 4 days (96 hours) postdose
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AUC(0 to inf) for plasma and whole blood total radioactivity is reported as hours*nanogram equivalents per milliliter (h*ng Eq/mL).
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Predose up to 4 days (96 hours) postdose
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Plasma PK of LY2886721: Maximum Observed Concentration (Cmax)
時間枠:Predose up to 4 days (96 hours) postdose
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Predose up to 4 days (96 hours) postdose
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PK of Radioactivity: Cmax
時間枠:Predose up to 4 days (96 hours) postdose
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The Cmax of total radioactivity in plasma and whole blood are reported as nanogram equivalents per milliliter (ng Eq/mL).
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Predose up to 4 days (96 hours) postdose
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Relative Abundance of LY2886721 and the Metabolites of LY2886721 in Plasma
時間枠:1 to 8 hours postdose
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The metabolites of LY2886721 were identified using a high performance liquid chromatography (HPLC) chromatogram.
The relative abundance of LY2886721 and its metabolites in plasma were reported as a percentage of recovered radioactivity and calculated by dividing the sum of the radioactive content of fractions contributing to a particular peak by the sum of the radioactive content of all fractions in the radio chromatogram, then multiplying by 100.
Radioactivity corresponds to 80 μCi [^14C]-LY2886721.
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1 to 8 hours postdose
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Relative Abundance of LY2886721 and the Metabolites of LY2886721 in Urine
時間枠:0 to 72 hours postdose
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The metabolites of LY2886721 were identified using an HPLC chromatogram.
The relative abundance of LY2886721 and its metabolites in urine were reported as a percentage of recovered radioactivity and calculated by dividing the sum of the radioactive content of fractions contributing to a particular peak by the sum of the radioactive content of all fractions in the radio chromatogram, then multiplying by 100.
Radioactivity corresponds to 80 μCi [^14C]-LY2886721.
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0 to 72 hours postdose
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Relative Abundance of LY2886721 and the Metabolites of LY2886721 in Feces
時間枠:0 to 144 hours postdose
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The metabolites of LY2886721 were identified using an HPLC chromatogram.
The relative abundance of LY2886721 and its metabolites in feces were reported as a percentage of recovered radioactivity and calculated by dividing the sum of the radioactive content of fractions contributing to a particular peak by the sum of the radioactive content of all fractions in the radio chromatogram, then multiplying by 100.
Radioactivity corresponds to 80 μCi [^14C]-LY2886721.
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0 to 144 hours postdose
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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6月1日
一次修了 (実際)
2011年7月1日
研究の完了 (実際)
2011年7月1日
試験登録日
最初に提出
2011年6月3日
QC基準を満たした最初の提出物
2011年6月3日
最初の投稿 (見積もり)
2011年6月7日
学習記録の更新
投稿された最後の更新 (実際)
2019年9月13日
QC基準を満たした最後の更新が送信されました
2019年8月9日
最終確認日
2019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。
LY2886721の臨床試験
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Eli Lilly and Company終了しました