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Study to Investigate the Pharmacokinetics and Safety of Cadazolid in Patients With Clostridium Difficile Infection

31. ledna 2014 aktualizováno: Actelion

A Phase 1, Open-label, Single Oral Dose Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Cadazolid in Patients With Severe Clostridium Difficile Infection (CDI)

The study investigated the pharmacokinetics, safety, and tolerability of cadazolid in subjects with severe Clostridium difficile diarrhea (CDAD) and whether this influenced the quantity of cadazolid absorbed into the systemic circulation.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

6

Fáze

  • Fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Chorvatsko
      • Zagreb, Chorvatsko, 1000
        • Clinical Hospital for Infective Disease

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 80 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Signed informed consent prior to any study-mandated procedure.
  • Non-pregnant females were to remain non-pregnant for 1 month after the end of the study. Female subjects of child-bearing potential must have had a negative serum pregnancy test at screening and must have used a reliable method of contraception
  • Subjects with severe CDAD; Clostridium difficile infection (CDI) must have been microbiologically proven, using a validated enzyme-linked immunosorbent assay (ELISA) for the detection of C. difficile toxin A (TcdA) and/or C. difficile toxin B (TcdB). The severity of CDAD was assessed according to the current European Union guidelines - European Society of Clinical Microbiology and Infectious Diseases (ESCMID).
  • Received oral vancomycin or oral/intravenous (i.v.) metronidazole therapy for the treatment of CDAD.
  • Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study.

Exclusion Criteria:

  • Known hypersensitivity to any excipients of the drug formulation.
  • Clinical evidence of any relevant disease other than CDAD and/or existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism or excretion of the study drug.
  • Veins unsuitable for i.v. puncture on either arm (e.g., veins that are difficult to locate, access, or puncture; veins with a tendency to rupture during or after puncture).
  • Subjects with rare hereditary fructose intolerance, glucose-galactose malabsorption, saccharase-isomaltase deficiency or previously undiagnosed diabetes mellitus.
  • Subjects who have a life-threatening condition, which may be related to CDAD or other underlying illness.
  • Any clinically relevant electrocardiogram (ECG) abnormality at screening.
  • Subjects who were unable to swallow or have difficulty swallowing.
  • Subjects with vomiting, ileus or not passing stool.
  • Likelihood of death within 72 hours from any cause.
  • Life-threatening or fulminant CDAD (White blood cell count > 30 × 10^9/L; temperature > 40 °C; or septic shock, peritoneal signs or significant dehydration).
  • History of ulcerative colitis or Crohn's disease.
  • Loss of 250 mL or more of blood within 3 months prior to screening.
  • Positive results from the hepatitis serology, except for vaccinated subjects, at screening.
  • Positive results from the human immunodeficiency virus (HIV) serology at screening.
  • Legal incapacity or limited legal capacity at screening.
  • Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Cadazolid
Single oral dose of 3000 mg.
Lék: Cadazolid
Cadazolid was provided as dry powder for oral suspension (Amber glass bottles of 60 mL). The powder was reconstituted with tap water by a pharmacist immediately prior to dispensing to subjects.
Ostatní jména:
  • ACT-179811

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Maximum plasma concentration (Cmax) of cadazolid
Časové okno: 144 hours
Blood samples for pharmacokinetic analysis taken immediately prior to dosing with cadazolid, and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after dosing. Cmax was calculated on the basis of the blood sampling time points.
144 hours
Time to reach maximum plasma concentration (tmax) of cadazolid
Časové okno: 144 hours
Blood samples for pharmacokinetic analysis taken immediately prior to dosing with cadazolid, and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after dosing. tmax was calculated on the basis of the blood sampling time points.
144 hours
Area under the plasma concentration-time curve (AUC(0-144h)) of cadazolid
Časové okno: 144 hours
Blood samples for pharmacokinetic analysis taken immediately prior to dosing with cadazolid, and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after dosing. AUC(0-144) was calculated according to the linear trapezoidal rule using the measured concentration-time values above the limit of quantification.
144 hours
Unchanged cadazolid in urine up to Day 7
Časové okno: 144 hours
Urine was collected into standard-weight polyethylene containers over the following time intervals: 0-12 h, 12-24 h, 24-36 h, 36-48 h, 48-72 h, 72-96 h, 96-120 h, and 120-144 h. The concentration of cadazolid was determined using validated liquid chromatography-tandem mass spectrometry assays. The amount of drug excreted in the urine was obtained by multiplying the concentration of drug by the volume of matrix collected.
144 hours
Unchanged cadazolid in faeces up to Day 7
Časové okno: 144 hours
Faeces were collected in pre-weighed polypropylene boxes. The concentration of cadazolid was determined using validated liquid chromatography-tandem mass spectrometry assays. The amount of drug excreted in the faeces was obtained by multiplying the concentration of drug by the volume of matrix collected.
144 hours

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from baseline up to Day 7 in systolic blood pressure (SBP)
Časové okno: 144 hours
Blood pressure (systolic and diastolic) and pulse rate were measured using an automatic oscillometric device, always on the leading arm (i.e., leading arm = writing arm). Measurements were recorded in the supine position after the subject had rested for a 5-minute period.
144 hours
Change from baseline up to Day 7 in diastolic blood pressure (DBP)
Časové okno: 144 hours
Blood pressure (systolic and diastolic) and pulse rate were measured using an automatic oscillometric device, always on the leading arm (i.e., leading arm = writing arm). Measurements were recorded in the supine position after the subject had rested for a 5-minute period.
144 hours
Change from baseline up to Day 7 in pulse rate
Časové okno: 144 hours
Blood pressure (systolic and diastolic) and pulse rate were measured using an automatic oscillometric device, always on the leading arm (i.e., leading arm = writing arm). Measurements were recorded in the supine position after the subject had rested for a 5-minute period.
144 hours
Change from baseline to Day 7 in body weight
Časové okno: 144 hours
Body weight was measured using the same weighing scales.
144 hours
Change from baseline up to Day 7 in heart rate
Časové okno: 144 hours
Heart rate was determined from standard 12-lead electrocardiographs (ECGs) recorded in the supine position, after a 5-minute period of resting.
144 hours
Change from baseline up to Day 7 in PQ interval (time interval from the beginning of the P wave to the beginning of the QRS complex)
Časové okno: 144 hours
PQ interval was determined from standard 12-lead ECGs recorded in the supine position, after a 5-minute period of resting.
144 hours
Change from baseline up to Day 7 in QRS duration (time interval from the beginning of the Q wave to the end of the S wave)
Časové okno: 144 hours
QRS duration was determined from standard 12-lead ECGs recorded in the supine position, after a 5-minute period of resting.
144 hours
Change from baseline up to Day 7 in QT (time interval from beginning of the Q wave until end of the T wave)
Časové okno: 144 hours
QT interval was determined from standard 12-lead ECGs recorded in the supine position, after a 5-minute period of resting.
144 hours
Change from baseline up to Day 7 in QT interval according to Bazett's correction (QTcB)
Časové okno: 144 hours
QTcB interval was determined from standard 12-lead ECGs recorded in the supine position, after a 5-minute period of resting. The QTcB interval is the QT interval (interval from beginning of the Q wave until end of the T wave) corrected for heart rate with Bazett's formula (QTcB = QT/RR^0.5 where RR is 60/heart rate)
144 hours
Change from baseline up to Day 7 in QT interval according to Fridericia's correction (QTcF)
Časové okno: 144 hours
QTcF interval was determined from standard 12-lead ECGs recorded in the supine position, after a 5-minute period of resting. The QTcF interval is the QT interval (interval from beginning of the Q wave until end of the T wave) corrected for heart rate with Fridericia's formula (QTcB = QT/RR^0.33 where RR is 60/heart rate)
144 hours
Frequency of treatment-emergent ECG abnormalities from up to Day 7
Časové okno: 144 hours
Treatment-emergent abnormalities were determined from standard 12-lead ECGs recorded in the supine position, after a 5-minute period of resting. An ECG abnormality was considered treatment-emergent if it was not present during the screening period and/or at time of pre-dose assessment.
144 hours

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Actelion

Vyšetřovatelé

  • Ředitel studie: Alison Mackie, MSc, Actelion

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. srpna 2012

Primární dokončení (Aktuální)

1. září 2012

Dokončení studie (Aktuální)

1. září 2012

Termíny zápisu do studia

První předloženo

30. ledna 2014

První předloženo, které splnilo kritéria kontroly kvality

31. ledna 2014

První zveřejněno (Odhad)

3. února 2014

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

3. února 2014

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

31. ledna 2014

Naposledy ověřeno

1. ledna 2014

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • AC-061-103

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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