A Ph 1 Study of Epanova® in Healthy Chineses
3 luglio 2018 aggiornato da: 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.
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
14
Fase
- Fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Beijing, Cina, 100029
- Research Site
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 45 anni (Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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1. Plasma concentrations versus time profile of EPA and DHA
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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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6. Apparent clearance for parent drug estimated as dose divided by AUC (CL/F)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Number of subjects with adverse events.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Yang Lin, MD, Beijing Anzhen Hospital
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
4 giugno 2018
Completamento primario (Effettivo)
27 giugno 2018
Completamento dello studio (Effettivo)
27 giugno 2018
Date di iscrizione allo studio
Primo inviato
4 maggio 2018
Primo inviato che soddisfa i criteri di controllo qualità
20 giugno 2018
Primo Inserito (Effettivo)
29 giugno 2018
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
5 luglio 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
3 luglio 2018
Ultimo verificato
1 luglio 2018
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- D5881C00001
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .