A Relative Bioavailability and Food Effect Study of New Formulations
2017年3月10日 更新者:Eli Lilly and Company
Relative Bioavailability of the LY3009104 Free Base Test Formulation Compared to the Reference Phosphate Salt Formulation and the Effect of Food on the Bioavailability of the Test Formulation in Healthy Subjects
The purpose of this trial is to assess the effect of 3 formulations on the relative bioavailability of LY3009104.
Participants will receive single dose of LY3009104 on 4 separate occasions with and without food.
Safety evaluation and serial pharmacokinetic (PK) samples will be collected during each treatment period.
Approximately 5 to 7 days of washout period between each treatment and a follow-up visit will occur approximately 5 to 7 days after the last dose of study drug.
調査の概要
研究の種類
介入
入学 (実際)
15
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:
- Overtly healthy males or females as determined by medical history and physical examination
- Have a body mass index (BMI) of 18.5 to 29.9 kilograms per square meter (kg/m^2), inclusive, at screening
- 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 normal blood pressure and pulse rate as determined by the investigator
- Have venous access sufficient to allow for blood sampling
- 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 ethical review board (ERB) governing the site
Male Participants:
- Agree to use two forms of highly effective methods of birth control [oral, injectable, or implanted hormonal contraceptives; condom with spermicidal foam/gel/film/cream/suppository; occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; intrauterine device; intrauterine system, for example, progestin releasing coil; and vasectomised male (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate)] with female partners of childbearing potential during the study and for at least 3 months following the last dose of study drug
Female participants:
- Are women of non-childbearing potential, defined as: women with Mayer Rokitansky Kuster Hauser Syndrome (also referred to as Clinical Absence of Uterus and Vagina), or women who have had surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation), or women greater than 60 years of age, or women greater than 40 and less than 60 years of age who have had a cessation of menses for at least 12 months and a follicle-stimulating hormone (FSH) test confirming non-childbearing potential [FSH ≥40 milli-international units per milliliter (mIU/mL)]
Exclusion Criteria:
- Are currently enrolled in, or 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
- Have a history of 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)
- Are participants who have previously received the investigational product in this study, have completed or withdrawn from this study or any other study investigating LY3009104
- 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
- Current or recent history (<30 days prior to screening and/or <45 days prior to Check-in) of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection
- Have an absolute neutrophil count (ANC) less than 2000 cells per microliter (cell/μL). For abnormal values, a single repeat will be allowed
- Have a 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
- Regularly use known drugs of abuse
- Have had symptomatic herpes zoster or herpes simplex infection within 90 days prior to the first dose
- Have been exposed to a live vaccine within 12 weeks prior to the first dose or expected to need/receive a live vaccine (including herpes zoster vaccination) during the course of the study
- Show evidence of human immunodeficiency virus (HIV) infection and/or positive human 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 over-the-counter or prescription medication and herbal supplements within 14 days prior to dosing and during the study
- Intend to use vitamins and mineral supplements within 2 days prior to dosing and during the study
- Have donated blood of more than 450 milliliters (mL) within the previous 3 months
- Have consumed grapefruit, starfruit, pomelos, or products containing these fruits, 7 days prior to the first dose and during the study
- 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 for 48 hours prior to admission in each period until the 48 hour PK sample has been collected [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]
- Have used any tobacco-containing 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 enrollment
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:処理
- 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: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:LY3009104 Reference Formulation
8 milligrams (mg) LY3009104 (two 4-mg phosphate salt capsules), administered orally in the fasted state, once only.
There will be a washout period of 5 to 7 days between doses of study drug.
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経口投与
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実験的:LY3009104 Test Formulation 1
8 mg LY3009104 (one 8-mg smaller particle free base tablet), administered orally in the fasted state, once only.
There will be a washout period of 5 to 7 days between doses of study drug.
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経口投与
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実験的:LY3009104 Test Formulation 2
8 mg LY3009104 (one 8-mg larger particle free base tablet), administered orally in the fasted state, once only.
There will be a washout period of 5 to 7 days between doses of study drug.
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経口投与
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実験的:LY3009104 Test Formulation 2 + Meal
8 mg LY3009104 (one 8-mg larger particle free base tablet), administered orally with high-fat/high calorie meal, once only.
There will be a washout period of 5 to 7 days between doses of study drug.
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経口投与
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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: Plasma Concentration-Time Curve (AUC)
時間枠:Predose up to 48 hours postdose for each of the 4 treatment periods
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The area under the concentration-time curve from time 0 to infinity [AUC(0-inf)] is reported for participants who received either LY3009104 tablets or capsules in a fasted or fed state.
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Predose up to 48 hours postdose for each of the 4 treatment periods
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二次結果の測定
結果測定 |
時間枠 |
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Pharmacokinetics: Maximum Plasma Concentration (Cmax)
時間枠:Predose up to 48 hours postdose for each of the 4 treatment periods
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Predose up to 48 hours postdose for each of the 4 treatment periods
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Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax)
時間枠:Predose up to 48 hours postdose for each of the 4 treatment periods
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Predose up to 48 hours postdose for each of the 4 treatment periods
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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7月1日
一次修了 (実際)
2011年9月1日
研究の完了 (実際)
2011年9月1日
試験登録日
最初に提出
2011年7月19日
QC基準を満たした最初の提出物
2011年7月19日
最初の投稿 (見積もり)
2011年7月20日
学習記録の更新
投稿された最後の更新 (実際)
2017年4月21日
QC基準を満たした最後の更新が送信されました
2017年3月10日
最終確認日
2017年3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。