- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03996226
A Food-Effect Study of E7386 in Healthy Participants
13 november 2019 uppdaterad av: Eisai Inc.
A Phase 1 Food-Effect Study of E7386 in Healthy Subjects
The primary objective of this study is to determine the effect of food in healthy participants on the bioavailability of E7386 following single dose administration with and without a meal.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
17
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Texas
-
Austin, Texas, Förenta staterna, 78744
- PPD
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 55 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Non-smoking, healthy participants at the time of informed consent.
- Body Mass Index (BMI) greater than (>) 18 and less than or equal to (<=) 30 kilogram per square meter (kg/m^2) at Screening.
Exclusion Criteria:
- Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [ß-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 international units per litre (IU/L) or equivalent units of ß-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug
Females of childbearing potential who:
Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:
- total abstinence (if it is their preferred and usual lifestyle)
- an intrauterine device or intrauterine hormone-releasing system
- a contraceptive implant
- an oral contraceptive (with additional barrier method) (Participant must be on a stable dose of the same oral contraceptive product for at least 28 days before dosing and throughout the study and for 28 days after study drug discontinuation)
- have a vasectomized partner with confirmed azoospermia
- Do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing)
- Males who have not had a successful vasectomy (confirmed azoospermia) and their female partners meet the exclusion criteria No: 2, above. If the female partner is pregnant, then males who do not agree to use Barrier contraception (latex or synthetic condoms) throughout the study period and for 90 days after study drug discontinuation. No sperm donation is allowed during the study period and for 90 days after study drug discontinuation
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing
- Evidence of disease that may influence the outcome of the study within 4 weeks before dosing; eg, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or participants who have a congenital abnormality in metabolism
- Any history of major surgery, e.g., intestinal resections, hepatectomy, nephrectomy, digestive organ resection that may affect absorption, metabolism or excretion of E7386.
- Any clinically abnormal symptom or organ impairment found by medical history at Screening, and physical examinations, vital signs, electrocardiogram (ECG) finding, or laboratory test results that require medical treatment at Screening
- Clinically significant ECG abnormality including a marked baseline prolongation of QT/corrected QT interval (QTc) (example: repeated demonstration of a QTc interval greater than (>) 500 milliseconds [msec]), or a family history of prolonged QTc syndrome or sudden death
- History of drug or alcohol misuse within 6 months prior to Screening, or who had a positive urine drug test at Screening or Baseline
- Diagnosed with acquired immune deficiency syndrome, or test positive for human immunodeficiency virus (HIV) at screening
- Active viral hepatitis (A, B or C) as demonstrated by positive serology at Screening
- Use of prescription drugs within 4 weeks prior to dosing
- Intake of over-the-counter medications within 2 weeks prior to dosing
- Intake of caffeinated beverages or food within 72 hours prior to dosing
- Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week of dosing
- Participated in another clinical trial less than 4 weeks prior to dosing or was currently enrolled in another clinical trial
- Consumed grapefruit, starfruit, Seville oranges or their products within 7 days prior to dosing
- Consumed herbal preparations/medications including but not limited to: St. John's wort, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone, yohimbe, saw palmetto, and ginseng within 7 days prior to dosing
- Allergic to E7386 or any of the tablet's ingredients
- Known history of clinically significant drug or food allergies, or presently experiencing significant seasonal or perennial allergy at Screening.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: E7386: Fed + Fast
Participants will receive a single oral dose of E7386 tablet in fed condition on Day 1 of treatment period 1 followed by a single oral dose of E7386 tablet in fasted condition on Day 8 of treatment period 2. A washout period of 7 days will be maintained between the 2 treatment periods.
|
E7386 oral tablets.
|
|
Experimentell: E7386: Fast + Fed
Participants will receive a single oral dose of E7386 tablet in fasted condition on Day 1 of treatment period 1 followed by a single oral dose of E7386 tablet in fed condition on Day 8 of treatment period 2. A washout period of 7 days will be maintained between the 2 treatment periods.
|
E7386 oral tablets.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Cmax: Maximum Observed Plasma Concentration for E7386
Tidsram: Day 1: 0-48 hours; Day 8: 0-48 hours
|
Day 1: 0-48 hours; Day 8: 0-48 hours
|
|
Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for E7386
Tidsram: Day 1: 0-48 hours; Day 8: 0-48 hours
|
Day 1: 0-48 hours; Day 8: 0-48 hours
|
|
AUC0-t: AUC 0-t: Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for E7386
Tidsram: Day 1: 0-48 hours; Day 8: 0-48 hours
|
Day 1: 0-48 hours; Day 8: 0-48 hours
|
|
AUC0-inf: Area Under the Plasma Concentration-time Curve from Time 0 to Infinite Time for E7386
Tidsram: Day 1: 0-48 hours; Day 8: 0-48 hours
|
Day 1: 0-48 hours; Day 8: 0-48 hours
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
7 juni 2019
Primärt slutförande (Faktisk)
29 oktober 2019
Avslutad studie (Faktisk)
29 oktober 2019
Studieregistreringsdatum
Först inskickad
21 juni 2019
Först inskickad som uppfyllde QC-kriterierna
21 juni 2019
Första postat (Faktisk)
24 juni 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
14 november 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 november 2019
Senast verifierad
1 juni 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- E7386-A001-001
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Ja
IPD-planbeskrivning
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på E7386
-
Eisai LimitedUpphängd
-
Eisai LimitedAvslutad
-
Eisai Inc.Aktiv, inte rekryterandeAvancerade neoplasmerFörenta staterna, Storbritannien
-
Eisai Co., Ltd.Aktiv, inte rekryterandeKolorektala neoplasmer | Gastrointestinala tumörer | Fasta neoplasmerJapan
-
Charite University, Berlin, GermanyAlnylam PharmaceuticalsRekryteringKardiovaskulär sjukdom | Kardiovaskulär riskfaktor | Hemodialys | Kronisk njursjukdom som kräver kronisk dialys | HyperoxalemiTyskland
-
Medicines for Malaria VentureMahidol UniversityAvslutadMalaria, Falciparum | Malaria, Vivax
-
Eisai Inc.Merck Sharp & Dohme LLCAvslutadMelanom | Karcinom, hepatocellulärt | Kolorektala neoplasmerSpanien, Förenta staterna, Japan, Storbritannien
-
Eisai Inc.Aktiv, inte rekryterandeNeoplasmer | Karcinom, hepatocellulärt | Neoplasmer i levern | Kolorektala neoplasmer | Endometriella neoplasmerFörenta staterna, Spanien, Taiwan, Kina, Danmark, Kanada, Frankrike, Italien, Sydkorea, Japan