- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00811356
A First Time in Human Study in Healthy Volunteers to Investigate a New Medicine to Treat Malaria
A Single-Blind, Placebo-Controlled, Randomized First Time in Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Dose Escalation of GSK932121 in Healthy Adult Subjects
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Malaria is a type of parasitic infection, common in tropical and subtropical regions of the world, including parts of the Americas, Asia, and Africa. In recent years there has been a rapid spread of drug resistant malaria which makes it necessary to develop new antimalarial treatments. In animal studies, GSK932121 is shown to be able to kill the malaria parasite and is fully active against drug resistant malaria parasites. It is hoped that information collected on this study will lead to an improved treatment for malaria.
This is a first time in human fusion study which has 3 parts:
Part A - single dose escalation/ food effect: a study where the study drug is given once only- first at the lowest dose of in a group of participants and the dose increased only if the previous dose is found to be safe. It also looks at the effect of food on the study drug in the body Part B - repeat dose escalation: a study where the study drug will be given daily for up to 7 days - first at a lower dose in a group of participants and the dose increased for the next group only if the previous dose is found to be safe and Part B - drug-drug interaction: a study where the study drug will be given daily for up to 7 days at a dose determined to be safe in previous groups of participants and looking at the effect of the study drug on other specific approved medications (such as rosiglitazone--a diabetic medication and rosuvastatin--a cholesterol lowering medication) in the body.
Safety will be assessed by measurement of vital signs, cardiac monitoring, spirometry, collection of adverse event assessments, renal biomarkers and laboratory safety tests.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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Victoria
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Melbourne, Victoria, Australien, 3004
- GSK Investigational Site
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Male or female between 18 and 50 years of age, inclusive
- Females of non-childbearing potential (as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea
- Body weight > 50 kg and BMI within the range 19 - 31 kg/m2 (inclusive)
- QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block
Exclusion Criteria:
- Positive pre-study drug/alcohol screen
- Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- A positive test for HIV antibody
- History of regular alcohol consumption within 6 months of the study
- Participation in a clinical trial with an investigational product within 30 days or 5 half-lives of the investigational product (whichever is longer) prior to start of the new study
- Exposure to more than four new drugs or within 12 months prior to the first dosing day
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that would be contraindicated
- Donation of blood or blood products in excess of 500 mL within a 56 day period.
- Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
- Lactating females.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- History of sensitivity to heparin or history of heparin-induced thrombocytopenia if heparin is used to maintain the patency of an intravenous cannula.
- Asthma or a history of asthma
- Smoking or history or regular use of tobacco- or nicotine-containing products within 2 months prior to screening
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Single Dose, Repeat Dose, Drug-Drug Interaction
GSK932121 or placebo will be administered as a single dose with or without food in a dose escalation manner. Once the results from the single dose is obtained and reviewed, GSK932121 or placebo will be administered as a repeat dose. The results from each repeat dose level will be reviewed prior to determining the next repeat dose level. To better understand the effect of GSK932121 on rosiglitazone and rosuvastatin, a drug-drug interaction arm will also be investigated in this study. Rosiglitazone and rosuvastatin will be administered alone, then GSK932121 will be given as a repeat dose. Rosiglitazone and rosuvastatin will then be administered in combination with GSK932121. |
GSK932121 is the study drug that will be tested in all parts of this study as described above.
Rosiglitazone and rosuvastatin will only be tested in the drug-drug interaction substudy.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Evidence of safety as determined by assessing adverse events, vital signs, spirometry, ECGs, telemetry, renal biomarkers, safety labs, and physical examination
Tidsramme: Part A: 3-4 months; Part B: ~1 month
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Part A: 3-4 months; Part B: ~1 month
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Plasma or blood concentrations of study drug
Tidsramme: Part A: 3-4 months; Part B: ~1 month
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Part A: 3-4 months; Part B: ~1 month
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Infektioner
- Vektorbårne sygdomme
- Parasitiske sygdomme
- Protozoiske infektioner
- Malaria
- Hypoglykæmiske midler
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antimetabolitter
- Antikolesteræmiske midler
- Hypolipidæmiske midler
- Lipidregulerende midler
- Hydroxymethylglutaryl-CoA-reduktasehæmmere
- Rosuvastatin Calcium
- Rosiglitazon
Andre undersøgelses-id-numre
- 111319
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Studiedata/dokumenter
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Studieprotokol
Informations-id: 111319Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Formular til informeret samtykke
Informations-id: 111319Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Statistisk analyseplan
Informations-id: 111319Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datasætspecifikation
Informations-id: 111319Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Annoteret sagsbetænkningsformular
Informations-id: 111319Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Klinisk undersøgelsesrapport
Informations-id: 111319Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Individuelt deltagerdatasæt
Informations-id: 111319Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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 Malaria
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Noguchi Memorial Institute for Medical ResearchMedical Research Center Unit The Gambia (MRCG)RekrutteringMalaria infektion | Malaria Asymptomatisk parasitæmi | Malaria Falciparum | Overførsel af malariaGhana
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Medicines for Malaria VentureSwiss Tropical & Public Health Institute; Rinda Ubuzima, Rwanda; Swiss BioQuant og andre samarbejdspartnereIkke rekrutterer endnuMalaria | Malaria infektion | Malariaprofylakse | Malaria (Plasmodium Falciparum) | Malaria Falciparum | Malaria parasitæmi | MalariaforebyggelseRwanda
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Medicines for Malaria VentureAsociacion Civil Selva AmazonicaAfsluttetPlasmodium Falciparum Malaria | Plasmodium Vivax MalariaPeru
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Menzies School of Health ResearchNational Health and Medical Research Council, Australia; Wellcome Trust; National...AfsluttetVivax malaria | Falciparum malariaIndonesien
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University of California, San FranciscoCenters for Disease Control and Prevention; University of Massachusetts... og andre samarbejdspartnereTrukket tilbagePlasmodium Falciparum Malaria | Plasmodium Vivax MalariaLaos
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University of OxfordWellcome Trust; Ministry of public Health AfghanistanAfsluttetVivax malaria | Ukompliceret Falciparum MalariaAfghanistan
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Menzies School of Health ResearchInternational Centre for Diarrhoeal Disease Research, Bangladesh; Addis... og andre samarbejdspartnereAfsluttetMalaria | Vivax malaria | Falciparum malariaEtiopien, Bangladesh, Indonesien
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Gadjah Mada UniversityMenzies School of Health Research; Eijkman Institute for Molecular Biology og andre samarbejdspartnereAfsluttet
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London School of Hygiene and Tropical MedicineWorld Health Organization; United Nations High Commissioner for Refugees; HealthNet TPO og andre samarbejdspartnereAfsluttetMalaria | Vivax malaria | Falciparum malariaPakistan
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Menzies School of Health ResearchNational Health and Medical Research Council, Australia; Wellcome Trust; National...AfsluttetVivax malaria | Falciparum malariaIndonesien
Kliniske forsøg med GSK932121; Rosiglitazone; Rosuvastatin
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Hospital Authority, Hong KongUkendtHjerte-kar-sygdomme | Nyresygdomme | Kronisk sygdomKina
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GlaxoSmithKlineAfsluttetDiabetes mellitus, type 2
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GlaxoSmithKlineAfsluttetDiabetes mellitus, type 2
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GlaxoSmithKlineAfsluttetNeuropati, diabetikerHolland
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Medstar Health Research InstituteGlaxoSmithKlineAfsluttet
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Baskent UniversityAfsluttetFedme | Type 2 diabetes mellitusKalkun
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University of CalgaryGlaxoSmithKlineAfsluttet
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Leiden University Medical CenterAfsluttetInsulin resistens | Kronisk nyresygdomHolland
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GlaxoSmithKlineAfsluttetAlzheimers sygdomForenede Stater, Australien, Spanien, Bulgarien, Polen, Tyskland, Filippinerne, Singapore, Belgien, Canada, Hong Kong, Korea, Republikken, Finland, Slovenien, Tjekkiet, Frankrig, Sydafrika, Sverige, Holland, Malaysia, Det Forenede... og mere
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Dana-Farber Cancer InstituteNational Cancer Institute (NCI)Afsluttet