- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03210649
Study to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of CKD-519
6. juli 2017 opdateret af: Chong Kun Dang Pharmaceutical
A Randomized, Double-blind, Placebo-controlled, Phase I Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of CKD-519 After Oral Administration in Healthy Adult Volunteers : Part I- Single Dosing / Part II- Multiple Dosing
The purpose of this study is to investigate the safety/tolerability and pharmacokinetics/pharmacodynamics of CKD-519
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
A randomized, double-blind, placebo-controlled, phase I clinical trial to investigate the safety/tolerability and pharmacokinetics/pharmacodynamics of CKD-519 after oral administration in healthy adult volunteers Part I- single dosing / Part II- multiple dosing
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
18
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Seodaemun-gu
-
Seoul, Seodaemun-gu, Korea, Republikken, 120-752
- Severance Hospital
-
-
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
19 år til 55 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Between 19 aged and 55 aged in healthy adult
- Body weight more than 55kg in male, 50kg in female
- Body Mass Index more than 18.5 and under 25(body mass index=kg/m2)
If female, must include more than one among the items
- The menopause(there is no natural menses for at least 2 years)
- Surgical Infertility(hysterectomy or bilateral oophorectomy, tubal ligation or other methods of infertility condition
- If men has sexual life with women of childbearing age, Necessarily he agrees that use condoms and do not sperm donation until two months during clinical trials and after the final dosage of investigational products
- Those who fully understand about this clinical trials after enough hearing, and then decided to join the clinical trials by themselves and to comply with the precautions written consent
Exclusion Criteria:
- Have clinically significant disease that hepatobiliary system(severe hepatic impairment, etc), kidney(severe renal impairment, etc), nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system(heart failure, etc) or mental illness, or a history of mental disease.
- Have a history of Toresades de pointes(TdP) or additional risk factors for Toresades de pointes(TdP). (Family history of long QT syndrome or sudden death, heart failure, hypokalemia, etc)
- Have a gastrointestinal disease history that can effect drug absorption(Crohn's disease, ulcers, etc.) or surgery(except simple appendectomy or hernia surgery)
- Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of drugs or additives.
- An impossible one who participates in clinical trial including screening tests(medical history taking, BP, 12-lead ECG, physical examination, blood&urine laboratory test result) before 28 days the taking investigational Products.
Defined by the following laboratory parameters
- AST, ALT>1.25 upper limit of normal range
- Total bilirubin>1.5 upper limit of normal range
- CPK>1.5 upper limit of normal range
- eGFR(using by MDRD method)<60mL/min/1.73m2
Defined by the following 12-lead ECG
- HR<40 or >110bpm
- PR interval>220ms or ≤110ms
- QRS interval>120ms
- QTcF<300ms or >450ms
- Pathologic Q-waves (defined as >40ms or depth>0.5mV)
- Incomplete or complete bundle branch block
- Pre-excitation (e.g., Wolfe-Parkinson-White Syndrome)
- Atrial fibrillation/flutter
- Second- or third-degree atrioventricular (AV)block
- Investigator judges to be unfavorable for consistently accurate QT measurements(e.g., indistinct QRS onset, low amplitude T wave, inverted or terminally inverted T wave, merged T/U waves, indistinct T wave offset , or prominent U wave that affects QT measurement)
- Sitting SBP>150mmHg or <90mmHg, sitting DBP>100mmHg or <50mmHg, after 5 minutes break.
- Drug abuse or have a history of drug abuse shows a positive for urine drug test.
- Pregnant or lactating women.
- A heavy caffeine consumer(caffeine>5 cups/day), alcohol consumer (alcohol>210g/week), or smoker(cigarette>10 cigarettes/day)
- Subject takes ethical drug or herbal medicine within 14 days, OTC within 7 days before the beginning of study treatment but investigator determine that the taking drug affect this study or could affect the safety of subjects.
- Subject who takes inhibitor and inducers of drug metabolizing enzyme (Barbiturates etc.) within 30 days.
- Taking concomitant medications that prolong the QT/QTc interval within 14 days before the beginning of study treatment.
- Taking foods containing grapefruit within 7 days before the beginning of study treatment(ex. Drinking containing grapefruit of 1L per a day or more within 7days before the beginning of study treatment)
- Subject who treated with any investigational drugs within 90 days before the beginning of study treatment
- Previously donate whole blood within 60 days or component blood within 30 days.
- An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
- Positive for Serology test(Hepatitis B, Hepatitis C, HIV)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: CKD-519 400mg(PartⅠ: 1day)
CKD-519 400mg(100mg x 4tabs) or placebo
|
Part 1 : CKD-519(100mg x 4 Tablets) for D1 Part 2 : CKD-519(100mg x 4 Tablets) for D1~D14
Part 1 : CKD-519 placebo(100mg x 4 Tablets) for D1 Part 2 : CKD-519 placebo(100mg x 4 Tablets) for D1~D14
|
|
Eksperimentel: CKD-519 400mg(PartⅡ: 14days)
CKD-519 400mg(100mg x 4tabs) or placebo
|
Part 1 : CKD-519(100mg x 4 Tablets) for D1 Part 2 : CKD-519(100mg x 4 Tablets) for D1~D14
Part 1 : CKD-519 placebo(100mg x 4 Tablets) for D1 Part 2 : CKD-519 placebo(100mg x 4 Tablets) for D1~D14
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Maximum Plasma Concentration [Cmax] of CKD-519
Tidsramme: Part I - Day1: 0(predose)~168hour, Part II - Day1: 0(predose)~24hour, Day3~Day13:0(predose), Day14: 0(predose)~168hour
|
Pharmacokinetics after administration of single and multiple doses
|
Part I - Day1: 0(predose)~168hour, Part II - Day1: 0(predose)~24hour, Day3~Day13:0(predose), Day14: 0(predose)~168hour
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pharmacodynamics(Lipid Parameter) of CKD-519
Tidsramme: PartⅡ- Day1, Day3, Day7, Day10, Day12, Day14, Day15, Day16, Day17, Day21
|
simultaneous with laboratory test after multiple administration
|
PartⅡ- Day1, Day3, Day7, Day10, Day12, Day14, Day15, Day16, Day17, Day21
|
|
Pharmacodynamics(CETP) of CKD-519
Tidsramme: Day1: 0(predose)~168hour
|
Pharmacodynamics after administration of single and multiple doses
|
Day1: 0(predose)~168hour
|
|
Pharmacodynamics(QC/QTc) of CKD-519
Tidsramme: Part II - Day-1, Day 1, Day14
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Pharmacokinetics after multiple administration
|
Part II - Day-1, Day 1, Day14
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Area Under the Curve [AUC] [Cmax] of CKD-519
Tidsramme: Part I - Day1: 0(predose)~168hour, Part II - Day1: 0(predose)~24hour, Day3~Day13:0(predose), Day14: 0(predose)~168hour
|
Pharmacokinetics after administration of single and multiple
|
Part I - Day1: 0(predose)~168hour, Part II - Day1: 0(predose)~24hour, Day3~Day13:0(predose), Day14: 0(predose)~168hour
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
7. marts 2017
Primær færdiggørelse (Faktiske)
24. april 2017
Studieafslutning (Faktiske)
24. april 2017
Datoer for studieregistrering
Først indsendt
2. juni 2017
Først indsendt, der opfyldte QC-kriterier
6. juli 2017
Først opslået (Faktiske)
7. juli 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. juli 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. juli 2017
Sidst verificeret
1. juli 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 148MAD16018
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