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A Ph 1 Study of Epanova® in Healthy Chineses

3 juillet 2018 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

14

Phase

  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Chine
      • Beijing, Chine, 100029
        • Research Site

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 45 ans (Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Science basique
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Epanova
Epanova® capsule, per oral
Médicament: 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.
Autres noms:
  • Omega-3 carboxylic acids

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
1. Plasma concentrations versus time profile of EPA and DHA
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of subjects with adverse events.
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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).

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

AstraZeneca

Les enquêteurs

  • Chercheur principal: Yang Lin, MD, Beijing Anzhen Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

4 juin 2018

Achèvement primaire (Réel)

27 juin 2018

Achèvement de l'étude (Réel)

27 juin 2018

Dates d'inscription aux études

Première soumission

4 mai 2018

Première soumission répondant aux critères de contrôle qualité

20 juin 2018

Première publication (Réel)

29 juin 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 juillet 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 juillet 2018

Dernière vérification

1 juillet 2018

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • D5881C00001

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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