- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01713621
OZ439 PhIIa Study in Plasmodium Falciparum: Extended Observation
17 mars 2017 uppdaterad av: Medicines for Malaria Venture
The Extended Observation Over a Period of 28 Days of the Effects of Single Doses of OZ439 on the Recrudescence of Plasmodium Falciparum Malaria - a PhIIa, Open Label Study in Adult Patients
This study aims to investigate the concentration dependent effects of OZ439 on the clearance of P. falciparum parasites in patients, specifically the determination of an in-vivo minimum inhibitory concentration (MIC) of OZ439.
Characterisation of PK-PD (Pharmacokinetic-Pharmacodynamic) relationships is essential for rational evidence based dosing.
The adaptive investigation of a range of doses will provide the best chance of accurate PK-PD characterisation, allowing the observation of Plasmodium falciparum growth dynamics and the subsequent identification of MIC and MPC (minimum parasiticidal concentration).
Additionally the tolerability and pharmacokinetics of OZ439 will be confirmed.
The PK/PD relationship between OZ439 exposure and subsequent effects on parasitaemia will be investigated.
Studieöversikt
Studietyp
Interventionell
Inskrivning (Faktisk)
25
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Bangkok, Thailand, 10400
- Faculty of Tropical Medicine,
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Tak
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Mae Ramat, Tak, Thailand, 63140
- Mae Ramat District hospital
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Mae Sot, Tak, Thailand, 63110
- Shoklo Malaria Research Unit
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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 60 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Male or female patients between the age of 18 and 60 years, inclusive
- Body weight between 45 kg and 90 kg inclusive
Presence of mono-infection of P. falciparum confirmed by:
- Fever, as defined by axillary temperature ≥ 37.5°C or oral/rectal/tympanic temperature ≥ 38°C, or history of fever in the previous 24 hours (history of fever must be documented) and,
- Microscopically confirmed parasite infection: 1,000 to 75,000 asexual parasite count/µL blood.
- Written informed consent, in accordance with local practice, provided by patient. If the patient is unable to write, witnessed consent is permitted according to local ethical considerations
- Ability to swallow oral medication
- Ability and willingness to participate and access the health facility
- Agree to hospitalization for at least 72h until parasites have fallen below the level of polymerase chain reaction (PCR) detection and have no signs or symptoms of malaria; and then to return once daily to the study centre for blood sampling for quantitative polymerase chain reaction (qPCR), and rehospitalisation when qPCR levels are detectable.
Exclusion Criteria:
- Patients with signs and symptoms of severe/complicated malaria requiring parenteral treatment according to the World Health Organization Criteria 2010
- Mixed Plasmodium infection
- Severe vomiting, defined as more than three times in the 24 hours prior to inclusion in the study or inability to tolerate oral treatment, or severe diarrhoea defined as 3 or more watery stools per day
- Presence of other serious or chronic clinical condition requiring hospitalization
- Severe malnutrition (defined as the weight-for-height being below -3 standard deviation or less than 70% of median of the NCHS/WHO normalized reference values)
- Known history or evidence of clinically significant disorders such as cardiovascular (including arrhythmia, QTc interval greater than or equal to 450 msec), respiratory (including active tuberculosis), history of jaundice, hepatic, renal, gastrointestinal, immunological (including active HIV-AIDS), neurological (including auditory), endocrine, infectious, malignancy, psychiatric, history of convulsions or other abnormality (including head trauma)
- Known history of hypersensitivity, allergic or adverse reactions to artemisinin containing compounds or mefloquine
- Known active Hepatitis A Immunoglobulin M (IgM) (HAV-IgM), Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (HCV Ab)
- Have received any antimalarial treatment in the preceding 14 days, as determined by history and screening test
- Have received antibacterial with known antimalarial activity in the preceding 14 days
- Have received an investigational drug within the past 4 weeks
- Liver function tests (Aspartate Aminotransferase(ASAT)/Alanine Aminotransferase (ALAT) levels) > 2x upper limit of normal (ULN) if Total Bilirubin normal or >1.5xULN if Total bilirubin between >1 and >1.5xULN
- Hemoglobin (Hb) level =< 8g/dl
- Total Bilirubin > 1.5XULN
- Serum creatinine levels more than 2 times the upper limit of normal range (>2xULN).
- Female patients must be neither pregnant as demonstrated by a negative serum pregnancy test at screening and urinary pregnancy test pre-dose (the result of the pre-dose assessment must be confirmed negative prior to dosing) nor lactating, and must be willing to take measures not to become pregnant during the study period and safety follow-up period.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: OZ439 100mg
Single dose of 100mg of OZ439 administered as an oral suspension
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OZ439 is a novel synthetic trioxolane antimalarial agent
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Experimentell: OZ439 500mg
Single dose of 500mg of OZ439 administered as an oral suspension
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OZ439 is a novel synthetic trioxolane antimalarial agent
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Minimum Inhibitory Concentration (MIC) and Minimum Parasiticidal Concentration (MPC)
Tidsram: up to 28 days
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The estimated MIC and MPC were derived from the fitted parasitaemia concentration and PK/PD relationship.
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up to 28 days
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Sasithon Pukrittayakamee, MD, Faculty of Tropical Medicine, Mahidol University, Bangkok
- Huvudutredare: Francois Nosten, MD, Shoklo Malaria Research Unit, Faculty of Tropical medicine, Mahidol University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
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
1 mars 2013
Primärt slutförande (Faktisk)
1 april 2015
Avslutad studie (Faktisk)
1 april 2015
Studieregistreringsdatum
Först inskickad
22 oktober 2012
Först inskickad som uppfyllde QC-kriterierna
22 oktober 2012
Första postat (Uppskatta)
25 oktober 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
14 april 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 mars 2017
Senast verifierad
1 mars 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MMV_OZ439_12_006
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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 OZ439
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