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An Open-label, Single Dose, Parallel Design, Phase 1 Clinical Study of LCB01-0371

7. april 2016 opdateret af: LegoChem Biosciences, Inc

An Open-label, Single Dose, Parallel Design, Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Oral Dosage Form of LCB01-0371 in Healthy Volunteers

To investigate pharmacokinetics, safety and tolerability of LCB01-0371, LCB01-0371-B after a single oral dose in healthy male subjects.

To investigate safety, tolerability of LCB01-0371 after a single oral dose in healthy male subjects.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

An Open-label, Single dose, Parallel design, Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Oral dosage form of LCB01-0371 in Healthy Male Volunteers

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

12

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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 40 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Healthy male between 20 and 40 years of age at the time of screening
  2. Agree to continue to use a medically reliable dual contraception and not to donate sperm in this protocol for the duration of the study and for 28 days after last dose of investigational product
  3. Capable of giving written informed consent, willing to participate in this clinical trial, and willing to comply with all study requirements

Exclusion Criteria:

  1. History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) within 6 months possibly affecting absorption of clinical trial drugs, or history of surgery (except simple appendectomy and herniotomy)
  2. History of hypersensitivity reaction or history of clinically significant hypersensitivity reaction to LCB01-0371 or same class of the study drugs (linezolid) or other drugs including aspirin and antibiotics
  3. History of clinically significant disease such as allergic or anaphylactic reaction to drug, cardiovascular, peripheral vascular system, skin, mucous membrane, eye, otorhinolaryngologic system, respiratory, musculoskeletal, infection disease, Gastrointestinal system , liver, biliary system, endocrine, kidney, urogenital system, nervous system, psychiatric system, blood dyscrasia, tumor, fracture, problem(s)
  4. blood donation and transfusion within 60 days prior to screening visit
  5. Treatment with an other investigational product or Participation in other bioequivalence test within 90 days prior to screening visit
  6. Use medication which expected to influence in this study within 30 days prior to screening visit
  7. smokers over 10 cigarettes per day within 30 days prior to screening visit or unable to stop smoking in this protocol for the duration of the study from first dose of investigational product
  8. drinkers over 3 glasses alcohol drink per week within 30 days prior to screening visit or unable to stop drinking in this protocol for the duration of the study from first dose of investigational product
  9. positive result at urine drug screening test or urine nicotine test at screening visit
  10. positive result at serum test(hepatitis B, hepatitis C, HIV, syphilis) at screening visit
  11. corrected QT interval >450 msec or significant abnormalities on screening ECG
  12. other: Patients considered unable perform for the study by the investigator concerning

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: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group 1: LCB01-0371
Period 1: LCB01-0371 Tablet 400 mg Period 2: LCB01-0371 Tablet 400 mg
  1. Period:LCB01-0371 Tablet 400 mg
  2. Period: LCB01-0371 Tablet 400 mg
  1. Period:LCB01-0371 Tablet 800 mg
  2. Period: LCB01-0371 Tablet 1200 mg
Eksperimentel: Group 2: LCB01-0371
Period 1: LCB01-0371 Tablet 800 mg Period 2: LCB01-0371 Tablet 1200 mg
  1. Period:LCB01-0371 Tablet 400 mg
  2. Period: LCB01-0371 Tablet 400 mg
  1. Period:LCB01-0371 Tablet 800 mg
  2. Period: LCB01-0371 Tablet 1200 mg

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Pharmacokinetics: Peak Plasma Concentration (Cmax)
Tidsramme: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours
0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours
Pharmacokinetics: time to maximum concentration (Tmax)
Tidsramme: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours
0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours
Pharmacokinetics: Area under the plasma concentration versus time curve (AUC)
Tidsramme: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours
0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours

Sekundære resultatmål

Resultatmål
Tidsramme
Number of Adverse Event
Tidsramme: participants will be followed after hospital stay, an expected average of 16 weeks
participants will be followed after hospital stay, an expected average of 16 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Kyun-Seop Bae, MD PhD, Asan Medical Center

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

1. juli 2015

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Faktiske)

1. december 2015

Datoer for studieregistrering

Først indsendt

12. august 2015

Først indsendt, der opfyldte QC-kriterier

18. august 2015

Først opslået (Skøn)

20. august 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

8. april 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. april 2016

Sidst verificeret

1. april 2016

Mere information

Begreber relateret til denne undersøgelse

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Group 1:LCB01-0371

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