- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03760276
A Study to Evaluate the Appropriateness of the Voriconazole Dosing Regimen
29. november 2018 opdateret af: SeungHwan Lee, Seoul National University Hospital
A Pilot Study to Evaluate the Appropriateness of the Voriconazole Dosing Regimen Based on the Population Pharmacokinetic Model and the Influence of Sex on the Pharmacokinetics of Voriconazole
A pilot study was performed to evaluate the appropriateness of the voriconazole dosing regimen based on the population pharmacokinetic model and the influence of sex on the pharmacokinetics of voriconazole
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
11
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Seoul, Korea, Republikken, 03080
- Seoul National University Hospital Clinical Trial Center
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
20 år til 45 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Those who have been informed of the nature of the trial and have voluntarily agreed to participate in this study and have signed an IRB approved consent before all screening tests
- Healthy Korean male and female volunteers aged 20 to 45
- Those with a body weight of 50 kg or more and less than 90 kg and a body mass index (BMI) of 18 or more and less than 27 (BMI(kg/m2) = body weight (kg)/{height(m)}2
- CYP2C19 EM or PM
Exclusion Criteria:
- Subjects with clinical evidence of significant respiratory, circulatory, renal, hepatic, endocrine, blood, neuropsychiatric, skeletal or other chronic diseases, alcohol or drug addiction
- Subjects with a history of gastrointestinal disorders (Crohn's disease, ulcers, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of the test drug
- Those with a history of substance abuse within the last 2 months
- Those who have taken any prescribed medicines or herbal medicines within 2 weeks prior to the date of the first medicines, or those taking any general medicines (OTC) or vitamin preparations (eligible if the other conditions are reasonable according to the judgment of the investigator)
- Those who donate blood within 30 days before the date of the first dose or who have participated in the clinical study of other clinical trial drugs or marketed drugs within 3 months
- Those who have had significant adverse reactions such as hypersensitivity reactions to azole drugs including drugs for clinical research
- Those who are not planning on or planning to have a pregnancy during the trial and are not able to use a recognized method of contraception (eg, sterilization surgery of the person and partner, intrauterine contraceptive device, or diaphragm contraception (such as diaphragm or condom use)
- Persons who are continuously drinking (21 units / week, 1 unit = 10 g of pure alcohol) or who can not abstain from 3 days before the first dose to the end of the clinical trial
- Those who smoked more than 10 cigarettes per day for the last 3 months or who can not quit smoking 3 days before the first dose
- Those who consume grapefruit / caffeine-containing food within 3 days of the first dose or who cannot be prohibited during the clinical study period
- Screening tests for urine pregnancy (β-hCG) positive or lactating women
- Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- A person who is found to be unsuitable for participation in clinical research due to safety laboratory results or other reasons
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Voriconazole TBD mg tablet orally, every 12 hours for 7 days
|
To be determined mg of Voriconazole (Vfend®, anti-fungal agent)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Peak plasma concentration (Cmax)
Tidsramme: Day 1 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours, Day 5 12 hours, Day 6 0, 12 hours, Day 7 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
|
Pharmacokinetic sampling after administration of drugs from day 1 to day 7
|
Day 1 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours, Day 5 12 hours, Day 6 0, 12 hours, Day 7 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
|
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Area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast)
Tidsramme: Day 1 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours, Day 5 12 hours, Day 6 0, 12 hours, Day 7 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
|
Pharmacokinetic sampling after administration of drugs from day 1 to day 7
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Day 1 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours, Day 5 12 hours, Day 6 0, 12 hours, Day 7 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Genetic polymorphisms of CYP2C9 and CYP3A4
Tidsramme: Day 1 0 hour
|
Exploratory evaluation
|
Day 1 0 hour
|
|
Hepatic safety marker of miRNA-122
Tidsramme: Day 1 0 hour, Day 5 12 hour, Day 7 12 hour
|
Exploratory safety evaluation
|
Day 1 0 hour, Day 5 12 hour, Day 7 12 hour
|
|
Safety and tolerability evaluation by monitoring adverse events (number of subjects and cases)
Tidsramme: Day 1 to Day 12
|
Safety and tolerability evaluation
|
Day 1 to Day 12
|
|
Physical examination (list of current medications)
Tidsramme: Day 1 to Day 12
|
Safety and tolerability evaluation
|
Day 1 to Day 12
|
|
Physical examination (list of any symptoms or pain)
Tidsramme: Day 1 to Day 12
|
Safety and tolerability evaluation
|
Day 1 to Day 12
|
|
Physical examination (Medical and surgical history)
Tidsramme: Day 1 to Day 12
|
Safety and tolerability evaluation
|
Day 1 to Day 12
|
|
Evaluation of Vital signs (body temperature °C)
Tidsramme: Day 1 to Day 12
|
Safety and tolerability evaluation
|
Day 1 to Day 12
|
|
Evaluation of Vital signs (blood pressure mmHg)
Tidsramme: Day 1 to Day 12
|
Safety and tolerability evaluation
|
Day 1 to Day 12
|
|
Evaluation of Vital signs (pulse (heart rate, beats per minute))
Tidsramme: Day 1 to Day 12
|
Safety and tolerability evaluation
|
Day 1 to Day 12
|
|
Evaluation of Vital signs (breathing rate (respiratory rate, beats per minute))
Tidsramme: Day 1 to Day 12
|
Safety and tolerability evaluation
|
Day 1 to Day 12
|
|
Safety and tolerability evaluation by 12-lead ECG (P wave, PR interval, QRS complex, J-point, ST segment, T wave, Corrected QT interval, U wave)
Tidsramme: Day 1 to Day 12
|
Safety and tolerability evaluation
|
Day 1 to Day 12
|
|
number of participants with abnormal laboratory values (hematologic, chemical, urine)
Tidsramme: Day 1 to Day 12
|
Safety and tolerability evaluation
|
Day 1 to Day 12
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
20. august 2018
Primær færdiggørelse (Faktiske)
28. oktober 2018
Studieafslutning (Faktiske)
28. oktober 2018
Datoer for studieregistrering
Først indsendt
23. november 2018
Først indsendt, der opfyldte QC-kriterier
29. november 2018
Først opslået (Faktiske)
30. november 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. november 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. november 2018
Sidst verificeret
1. november 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Infektioner
- Bakterielle infektioner og mykoser
- Mykoser
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Enzymhæmmere
- Hormoner, hormonsubstitutter og hormonantagonister
- Cytokrom P-450 CYP3A-hæmmere
- Cytokrom P-450 enzymhæmmere
- Hormonantagonister
- Antifungale midler
- Steroidsyntesehæmmere
- 14-alfa-demethylasehæmmere
- Voriconazol
Andre undersøgelses-id-numre
- Voriconazole_CYP2C19
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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