A Ph 1 Study of Epanova® in Healthy Chineses
2018年7月3日 更新者：AstraZeneca
A Phase I, Open-label Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of Epanova® in Chinese Healthy Subjects Living in China
The purpose of this study is to explore the safety, tolerability, and PK of single and multiple doses of Epanova in healthy male and female Chinese subjects and to allow comparison of these parameters with the Western population studied to date.
調査の概要
詳細な説明
This is a single centre, open-label, single- and multiple-dose, PK study in Chinese healthy subjects.
Approximately 14 subjects will receive a single oral dose of Epanova 4 g followed by a 72-hour washout period, and then receive Epanova 4 g orally once daily for 14 consecutive days.
Subjects will undergo screening evaluations to determine eligibility within 4 weeks (28 days) prior to the first dose of investigational product (IP).
Subjects will be admitted to the clinical pharmacology unit approximately 48 hours prior to the first dosing (Day -2) and will stay at the unit until at least 72 hours (Day 20) after their last dose of IP (Day 17).
Blood samples will be collected for PK analyses.
Subjects will be monitored closely for adverse events throughout the study.
研究の種類
介入
入学 (実際)
14
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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Beijing、中国、100029
- Research Site
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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～45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
全て
説明
Inclusion Criteria:
- Subjects must be willing and able to give written informed consent by signing an IRB-approved Informed Consent Form (ICF) prior to admission to this study and follow the restrictions and procedures outlined for the study.
- Healthy adult males or females as determined by medical history, physical examination, and laboratory tests. Subjects are to be native Chinese, 18 to 45 years of age (inclusive) at the time of consent.
- Body mass index (BMI) ≥19 and ≤26 kg/m2 and weigh at least 50 kg.
- Medically healthy subjects with clinically insignificant screening results (eg, laboratory profiles, medical histories, electrocardiograms [ECGs], physical examination). Haemoglobin must be greater than the lower limit of normal. A 12-lead ECG with QTcF >340 msec and <450 msec.
- Acceptable supine blood pressure (BP) and heart rate as determined by the investigator (systolic BP ≤140 mm Hg, and diastolic BP ≤90 mm Hg).
- For women of childbearing potential (have not had tubal ligation, hysterectomy or surgical procedure for sterilisation), the results from a serum pregnancy test at screening and at Day -2 must be within the normal range. The subject must also agree to use an acceptable method of contraception throughout the trial. Women with an intact uterus are deemed postmenopausal if they are at least age 45, have had cessation of menses for at least 1 year, and have not taken hormones or oral contraceptives (including oestrogen or hormone replacement therapy) during the past 12 months.
Key Exclusion Criteria
- Past history of psychological or physical disorder.
- An individual who has abnormal laboratory values or an inappropriate current or past medical history for participation based on the PI's decision.
- Has a history or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- Has a positive urine drug/alcohol breath testing at the screening visit or on Day -2.
- Habitual users of drug(s) of abuse.
- Has tested positive for human immunodeficiency virus (HIV), hepatitis B (including surface antigen [HbsAg] positive healthy carrier), hepatitis C antibodies (HCV), or syphilis.
- Has used fish oil, other EPA and/or DHA containing supplements within 60 days of admission to the clinic.
- Has a known sensitivity or allergy to soybeans, fish, and/or shellfish.
- Has had a history of hypersensitivity or idiosyncratic reaction to compounds related to Epanova.
- Pregnant or lactating women.
- Those who have difficulty with blood sampling via a peripheral vein.
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：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：Epanova
Epanova® capsule, per oral
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A single dose of Epanova 4 g will be administered as 4 capsules (each containing 1 g of Epanova) followed by a 72-hour washout period in Chinese healthy subjects.
Subsequently, multiple doses of Epanova 4 g will be administered once daily for 14 consecutive days.
他の名前：
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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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1. Plasma concentrations versus time profile of EPA and DHA
時間枠：Blood sample will be collected on Day-1, Day1(-1h, -5min Pre-dose and 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose),Day2,3,4,7,11,14,16,and Day17 (-5min Pre-dose, 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose), Day18,19 and Day20
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To evaluate the PK of single and multiple oral doses of Epanova in Chinese healthy subjects
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Blood sample will be collected on Day-1, Day1(-1h, -5min Pre-dose and 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose),Day2,3,4,7,11,14,16,and Day17 (-5min Pre-dose, 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose), Day18,19 and Day20
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2. Observed maximum plasma concentration (Cmax)
時間枠：Blood sample will be collected on Day-1, Day1(-1h, -5min Pre-dose and 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose),Day2,3,4,7,11,14,16,and Day17 (-5min Pre-dose, 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose), Day18,19 and Day20
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To evaluate the PK of single and multiple oral doses of Epanova in Chinese healthy subjects
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Blood sample will be collected on Day-1, Day1(-1h, -5min Pre-dose and 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose),Day2,3,4,7,11,14,16,and Day17 (-5min Pre-dose, 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose), Day18,19 and Day20
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3. Time to reach maximum plasma concentration (tmax)
時間枠：Blood sample will be collected on Day-1, Day1(-1h, -5min Pre-dose and 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose),Day2,3,4,7,11,14,16,and Day17 (-5min Pre-dose, 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose), Day18,19 and Day20
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To evaluate the PK of single and multiple oral doses of Epanova in Chinese healthy subjects
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Blood sample will be collected on Day-1, Day1(-1h, -5min Pre-dose and 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose),Day2,3,4,7,11,14,16,and Day17 (-5min Pre-dose, 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose), Day18,19 and Day20
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4. Terminal half-life
時間枠：Blood sample will be collected on Day-1, Day1(-1h, -5min Pre-dose and 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose),Day2,3,4,7,11,14,16,and Day17 (-5min Pre-dose, 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose), Day18,19 and Day20
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To evaluate the PK of single and multiple oral doses of Epanova in Chinese healthy subjects
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Blood sample will be collected on Day-1, Day1(-1h, -5min Pre-dose and 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose),Day2,3,4,7,11,14,16,and Day17 (-5min Pre-dose, 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose), Day18,19 and Day20
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5. Area under the plasma concentration-time curve from time zero to time of last quantifiable analyte concentration (AUC0-t)), from time zero to 24 hours (AUC0-24h), and from time zero extrapolated to infinity (AUC)
時間枠：Blood sample will be collected on Day-1, Day1(-1h, -5min Pre-dose and 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose),Day2,3,4,7,11,14,16,and Day17 (-5min Pre-dose, 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose), Day18,19 and Day20
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To evaluate the PK of single and multiple oral doses of Epanova in Chinese healthy subjects
|
Blood sample will be collected on Day-1, Day1(-1h, -5min Pre-dose and 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose),Day2,3,4,7,11,14,16,and Day17 (-5min Pre-dose, 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose), Day18,19 and Day20
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6. Apparent clearance for parent drug estimated as dose divided by AUC (CL/F)
時間枠：Blood sample will be collected on Day-1, Day1(-1h, -5min Pre-dose and 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose),Day2,3,4,7,11,14,16,and Day17 (-5min Pre-dose, 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose), Day18,19 and Day20
|
To evaluate the PK of single and multiple oral doses of Epanova in Chinese healthy subjects
|
Blood sample will be collected on Day-1, Day1(-1h, -5min Pre-dose and 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose),Day2,3,4,7,11,14,16,and Day17 (-5min Pre-dose, 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose), Day18,19 and Day20
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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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Number of subjects with adverse events.
時間枠：Adverse event will be collected from Visit 4(Day1) to Visit 23 (Day20).
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Following categories will be collected and analyzed: any adverse event (AE), any AE causally related to investigational product (IP), serious adverse events (SAEs), SAEs causally related to IP, AEs with outcome of death, AEs leading to discontinuation of IP, and other significant AEs.
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Adverse event will be collected from Visit 4(Day1) to Visit 23 (Day20).
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Safety as determined by evaluation of blood pressure in mmHg
時間枠：Blood presure will be collected from Visit1(any day between Day-28 to Day-2) to Visit23(Day20).
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Measurement of blood pressure (systolic and diastolic in mmHg)
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Blood presure will be collected from Visit1(any day between Day-28 to Day-2) to Visit23(Day20).
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Safety as determined by evaluation of heart beat in beats per minute
時間枠：Heart beat will be collected from Visit1(any day between Day-28 to Day-2) to Visit23(Day20).
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Measurement of heart beat in beats per minute
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Heart beat will be collected from Visit1(any day between Day-28 to Day-2) to Visit23(Day20).
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Safety as determined by evaluation of body temperature in degree Celsius
時間枠：Body temperature will be collected from Visit1(any day between Day-28 to Day-2) to Visit23(Day20).
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Measurement of body temperature in degree Celsius
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Body temperature will be collected from Visit1(any day between Day-28 to Day-2) to Visit23(Day20).
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Safety as determined by evaluation of respiratory rate in breaths per minute
時間枠：Respiratory rate will be collected from Visit1(any day between Day-28 to Day-2) to Visit23(Day20).
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Measurement of respiratory rate in breaths per minute
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Respiratory rate will be collected from Visit1(any day between Day-28 to Day-2) to Visit23(Day20).
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Safety as determined by analysis of electrocardiograms
時間枠：Electrocardiograms will be collected at Visit1(any day between Day-28 to Day-2), Visit3(Day-1) and V23(Day20).
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Analysis of 12-lead electorcardiograms
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Electrocardiograms will be collected at Visit1(any day between Day-28 to Day-2), Visit3(Day-1) and V23(Day20).
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Safety as determined by abnormality in haematology
時間枠：Blood samples will be collected at Visit1(any day between Day-28 to Day-2), Visit2 (Day -2) and Visit23(Day20).
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Measurement of red blood cell count, white blood cell count, haemoglobin and platelets
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Blood samples will be collected at Visit1(any day between Day-28 to Day-2), Visit2 (Day -2) and Visit23(Day20).
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Safety as determined by abnormality in clinical chemistry
時間枠：Blood samples will be collected at Visit1(any day between Day-28 to Day-2), Visit2 (Day -2) and Visit23(Day20).
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Measurement of kidney function (e.g.urea ,creatinine, Uric acid), liver function(ALP, ALT, AST, albumin, total bilirubin, direct bilirubin), lipid profile(total cholesterol, triglycerides), potassium and hs-CRP
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Blood samples will be collected at Visit1(any day between Day-28 to Day-2), Visit2 (Day -2) and Visit23(Day20).
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Safety as determined by abnormality in urinalysis
時間枠：Urine samples will be collected at Visit1(any day between Day-28 to Day-2), Visit2 (Day -2) and Visit23(Day20).
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Measurement of leucocyte, red blood cells, protein and microscopy
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Urine samples will be collected at Visit1(any day between Day-28 to Day-2), Visit2 (Day -2) and Visit23(Day20).
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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
捜査官
- 主任研究者：Yang Lin, MD、Beijing Anzhen Hospital
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 (実際)
2018年6月4日
一次修了 (実際)
2018年6月27日
研究の完了 (実際)
2018年6月27日
試験登録日
最初に提出
2018年5月4日
QC基準を満たした最初の提出物
2018年6月20日
最初の投稿 (実際)
2018年6月29日
学習記録の更新
投稿された最後の更新 (実際)
2018年7月5日
QC基準を満たした最後の更新が送信されました
2018年7月3日
最終確認日
2018年7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。
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