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A Ph 1 Study of Epanova® in Healthy Chineses

3. července 2018 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

14

Fáze

  • Fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Čína
      • Beijing, Čína, 100029
        • Research Site

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 45 let (Dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Body mass index (BMI) ≥19 and ≤26 kg/m2 and weigh at least 50 kg.
  4. 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.
  5. Acceptable supine blood pressure (BP) and heart rate as determined by the investigator (systolic BP ≤140 mm Hg, and diastolic BP ≤90 mm Hg).
  6. 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

  1. Past history of psychological or physical disorder.
  2. An individual who has abnormal laboratory values or an inappropriate current or past medical history for participation based on the PI's decision.
  3. Has a history or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
  4. Has a positive urine drug/alcohol breath testing at the screening visit or on Day -2.
  5. Habitual users of drug(s) of abuse.
  6. Has tested positive for human immunodeficiency virus (HIV), hepatitis B (including surface antigen [HbsAg] positive healthy carrier), hepatitis C antibodies (HCV), or syphilis.
  7. Has used fish oil, other EPA and/or DHA containing supplements within 60 days of admission to the clinic.
  8. Has a known sensitivity or allergy to soybeans, fish, and/or shellfish.
  9. Has had a history of hypersensitivity or idiosyncratic reaction to compounds related to Epanova.
  10. Pregnant or lactating women.
  11. Those who have difficulty with blood sampling via a peripheral vein.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Základní věda
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Epanova
Epanova® capsule, per oral
Lék: Epanova
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.
Ostatní jména:
  • Omega-3 carboxylic acids

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
1. Plasma concentrations versus time profile of EPA and DHA
Časové okno: 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
2. Observed maximum plasma concentration (Cmax)
Časové okno: 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
3. Time to reach maximum plasma concentration (tmax)
Časové okno: 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
4. Terminal half-life
Časové okno: 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
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)
Časové okno: 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
6. Apparent clearance for parent drug estimated as dose divided by AUC (CL/F)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of subjects with adverse events.
Časové okno: Adverse event will be collected from Visit 4(Day1) to Visit 23 (Day20).
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.
Adverse event will be collected from Visit 4(Day1) to Visit 23 (Day20).
Safety as determined by evaluation of blood pressure in mmHg
Časové okno: Blood presure will be collected from Visit1(any day between Day-28 to Day-2) to Visit23(Day20).
Measurement of blood pressure (systolic and diastolic in mmHg)
Blood presure will be collected from Visit1(any day between Day-28 to Day-2) to Visit23(Day20).
Safety as determined by evaluation of heart beat in beats per minute
Časové okno: Heart beat will be collected from Visit1(any day between Day-28 to Day-2) to Visit23(Day20).
Measurement of heart beat in beats per minute
Heart beat will be collected from Visit1(any day between Day-28 to Day-2) to Visit23(Day20).
Safety as determined by evaluation of body temperature in degree Celsius
Časové okno: Body temperature will be collected from Visit1(any day between Day-28 to Day-2) to Visit23(Day20).
Measurement of body temperature in degree Celsius
Body temperature will be collected from Visit1(any day between Day-28 to Day-2) to Visit23(Day20).
Safety as determined by evaluation of respiratory rate in breaths per minute
Časové okno: Respiratory rate will be collected from Visit1(any day between Day-28 to Day-2) to Visit23(Day20).
Measurement of respiratory rate in breaths per minute
Respiratory rate will be collected from Visit1(any day between Day-28 to Day-2) to Visit23(Day20).
Safety as determined by analysis of electrocardiograms
Časové okno: Electrocardiograms will be collected at Visit1(any day between Day-28 to Day-2), Visit3(Day-1) and V23(Day20).
Analysis of 12-lead electorcardiograms
Electrocardiograms will be collected at Visit1(any day between Day-28 to Day-2), Visit3(Day-1) and V23(Day20).
Safety as determined by abnormality in haematology
Časové okno: Blood samples will be collected at Visit1(any day between Day-28 to Day-2), Visit2 (Day -2) and Visit23(Day20).
Measurement of red blood cell count, white blood cell count, haemoglobin and platelets
Blood samples will be collected at Visit1(any day between Day-28 to Day-2), Visit2 (Day -2) and Visit23(Day20).
Safety as determined by abnormality in clinical chemistry
Časové okno: Blood samples will be collected at Visit1(any day between Day-28 to Day-2), Visit2 (Day -2) and Visit23(Day20).
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
Blood samples will be collected at Visit1(any day between Day-28 to Day-2), Visit2 (Day -2) and Visit23(Day20).
Safety as determined by abnormality in urinalysis
Časové okno: Urine samples will be collected at Visit1(any day between Day-28 to Day-2), Visit2 (Day -2) and Visit23(Day20).
Measurement of leucocyte, red blood cells, protein and microscopy
Urine samples will be collected at Visit1(any day between Day-28 to Day-2), Visit2 (Day -2) and Visit23(Day20).

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

AstraZeneca

Vyšetřovatelé

  • Vrchní vyšetřovatel: Yang Lin, MD, Beijing Anzhen Hospital

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

4. června 2018

Primární dokončení (Aktuální)

27. června 2018

Dokončení studie (Aktuální)

27. června 2018

Termíny zápisu do studia

První předloženo

4. května 2018

První předloženo, které splnilo kritéria kontroly kvality

20. června 2018

První zveřejněno (Aktuální)

29. června 2018

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

5. července 2018

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

3. července 2018

Naposledy ověřeno

1. července 2018

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • D5881C00001

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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