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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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Victoria
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Melbourne, Victoria, Australië, 3004
- GSK Investigational Site
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Plasma or blood concentrations of study drug
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Infecties
- Vector overgedragen ziekten
- Parasitaire ziekten
- Protozoaire infecties
- Malaria
- Hypoglycemische middelen
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antimetabolieten
- Middelen tegen cholesterol
- Hypolipidemische middelen
- Vetregulerende middelen
- Hydroxymethylglutaryl-CoA-reductaseremmers
- Rosuvastatine Calcium
- Rosiglitazon
Andere studie-ID-nummers
- 111319
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Bestudeer gegevens/documenten
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Leerprotocool
Informatie-ID: 111319Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Formulier geïnformeerde toestemming
Informatie-ID: 111319Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Statistisch analyseplan
Informatie-ID: 111319Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Specificatie gegevensset
Informatie-ID: 111319Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Geannoteerd casusrapportformulier
Informatie-ID: 111319Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Klinisch onderzoeksrapport
Informatie-ID: 111319Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Gegevensset individuele deelnemers
Informatie-ID: 111319Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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