A Study of LY2881835 in Healthy People and People With Diabetes
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Escalating Oral Doses of LY2881835 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus
This will be the first study in which LY2881835 is given to humans in order to evaluate the safety and any side effects of LY2881835 in humans as well as how long LY2881835 stays in the body and its effect on blood sugar levels.
The study consists of two parts. In part A, healthy subjects will participate and in part B, patients with type 2 Diabetes Mellitus (T2DM) will participate.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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Singapore、シンガポール
- 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
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
All subjects:
- Are a healthy male or a healthy female who cannot become pregnant, or are patients with Type 2 Diabetes Mellitus (T2DM) who are not taking any drugs to lower blood sugar except metformin
- Have a body mass index (BMI) of at least 18.5 kilograms per meter squared (kg/m²) at screening
- Have blood pressure, pulse rate and clinical laboratory tests within the normal range for the population or investigator site, or with abnormalities deemed clinical insignificant by the investigator
- Have veins that are suitable for easy blood collection
- Are reliable and willing to be available for the whole study and are willing to follow study procedures
- Must have given written informed consent
Subjects with Type 2 Diabetes Mellitus (T2DM) only:
- Do not have any change to their diabetes treatment for at least 4 weeks prior to screening
- Have a glycosylated hemoglobin (HbA1c) level greater than or equal to 6% and less than or equal to 11% at screening
Exclusion Criteria:
All subjects:
- Are currently participating in or were in another new drug or medical research study in the last 30 days
- Have participated in this study before
- Have known allergies to compounds related to the study drug
- Currently have or used to have health problems or laboratory test results that in the opinion of the doctor, could interfere with understanding the results of this study
- Intend to use over-the-counter or prescription medications within 14 days prior to dosing or during the study. Hormone replacement therapy and intermittent use of paracetamol during the study is acceptable. For patients with Type 2 Diabetes Mellitus, medicines for control of high fats (For example, cholesterol), high blood pressure, are allowed.
- Have electrocardiogram (ECG) readings that are not suitable for the study
- Are unwilling to follow dietary restrictions/requirements for the study including 1) refrain from consuming foods or beverages containing grapefruit pomelo, star fruit, or Seville orange within 14 days of the start of the study drug dosing until collection of the last blood sample for drug assay and 2) consume only the meals provided during inpatient stays at the clinical research unit
- Have a history of drug or alcohol abuse
- Are infected with hepatitis B
- Are infected with human immunodeficiency disease virus (HIV)
- Have donated 450 milliliters (mL) or more of blood in the last 3 months or provided any blood donation within the last month from screening
- Have a regular alcohol intake greater than 21 units per week (males) and 14 units per week (females) or are not willing to abstain from alcohol while in the research unit
- Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic
- The study doctor thinks the subject should not participate for any other reasons
Subjects with Type 2 Diabetes Mellitus (T2DM) only:
- Have health complications due to poorly controlled diabetes as shown by blood and urine laboratory test results or based on physical examination and medical assessment, as determined by the study doctor
- Were hospitalised for poor control of their diabetes (ketoacidotic episode) in the last 6 months
- Currently using or have used insulin in the last 1 year to control their diabetes
研究計画
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：独身
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：LY2881835
One cohort of healthy participants will receive single oral doses of LY2881835 in up to 3 of the 4 periods in Part A (dose escalation: 0.5 milligram (mg), 1.5 mg, subsequent doses determined based on review of safety, tolerability, glycaemic response and available pharmacokinetic (PK) data from the first 2 dose levels). One cohort of participants with Type 2 Diabetes Mellitus (T2DM) will receive single oral doses of LY2881835 in up to 2 of the 3 periods in Part B (dose escalation: starting dose based on review of safety, tolerability, glycaemic response and available PK data from Part A). There is a washout period of at least 5 days between periods (doses). |
Administered orally
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プラセボコンパレーター：placebo
One cohort of healthy participants will receive a single oral dose of placebo in 1 of the 4 periods in Part A. Another cohort of participants with T2DM will receive a single oral dose of placebo in 1 of the 3 periods in Part B. There is a washout period of at least 5 days between periods (doses). |
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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Number of Participants With Clinically Significant Adverse Effects
時間枠：Baseline to study completion up to 3 months
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Clinically significant adverse effects are treatment emergent adverse events (TEAEs) possibly related to study drug.
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Baseline to study completion up to 3 months
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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 (PK): Area Under the Curve (AUC) of LY2881835
時間枠：Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24hours (h) post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose
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Not all the participants had quantifiable plasma concentrations at 48 hours, therefore only AUC from time zero to 24 hours [AUC(0-24 hours)] is provided.
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Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24hours (h) post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose
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Pharmacokinetics (PK): Maximum Concentration (Cmax) Of LY2881835
時間枠：Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose
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Not all the participants had quantifiable plasma concentrations at 48 hours, therefore only Cmax up to 24 hours post-dose is provided.
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Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose
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Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of LY2881835
時間枠：Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose
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Not all the participants had quantifiable plasma concentrations at 48 hours, therefore only Tmax up to 24 hours post dose is provided.
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Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose
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Glucose Area Under the Effective Concentration Curve (AUEC)
時間枠：Part A: Predose, 1.0, 1.5, 2.5, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18 and 24 h post-dose; Part B: Predose, 1.0, 1.5, 2.5, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18 and 24 h post-dose
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Glucose area under the serum concentration versus time curve (AUEC) was calculated using the linear trapezoidal rule from time 0 to 24 hours.
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Part A: Predose, 1.0, 1.5, 2.5, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18 and 24 h post-dose; Part B: Predose, 1.0, 1.5, 2.5, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18 and 24 h post-dose
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Glucagon-Like Peptide (Active GLP-1) Area Under the Effective Concentration Curve (AUEC)
時間枠：Part A: Predose, 1.5 and 2.5 h post-dose; Part B: Predose, 1.5 and 2.5 h post-dose
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Glucagon-like peptide (active GLP-1) area under the serum concentration versus time curve (AUEC) was calculated using the linear trapezoidal rule from time 0 to 2.5 hours.
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Part A: Predose, 1.5 and 2.5 h post-dose; Part B: Predose, 1.5 and 2.5 h post-dose
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C-Peptide Area Under the Effective Concentration Curve (AUEC)
時間枠：Part A: Predose, 1.0, 1.5, 2.5, 4, 5, 6 and 24 h post-dose; Part B: Predose, 1.0, 1.5, 2.5, 4, 5, 6 and 24 h post-dose
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C-Peptide area under the serum concentration versus time curve (AUEC) was calculated using the linear trapezoidal rule from time 0 to 6 hours.
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Part A: Predose, 1.0, 1.5, 2.5, 4, 5, 6 and 24 h post-dose; Part B: Predose, 1.0, 1.5, 2.5, 4, 5, 6 and 24 h post-dose
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 13747
- I4P-FW-GPFA (その他の識別子：Eli Lilly and Company)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.
This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.
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。
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