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A First Time in Human Study in Healthy Volunteers to Investigate a New Medicine to Treat Malaria

1. august 2017 oppdatert av: GlaxoSmithKline

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

The purpose of this study is to determine if the study drug (antimalarial medication) is safe when given to healthy subjects as a single dose or as repeated doses, to understand the effect of food on single doses of study drug and to determine if the study drug has an effect on other approved medications such as rosiglitazone and rosuvastatin.

Studieoversikt

Status

Avsluttet

Forhold

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

12

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • GSK Investigational Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 50 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
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
Part A: 3-4 months; Part B: ~1 month

Sekundære resultatmål

Resultatmål
Tidsramme
Plasma or blood concentrations of study drug
Tidsramme: Part A: 3-4 months; Part B: ~1 month
Part A: 3-4 months; Part B: ~1 month

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

11. desember 2008

Primær fullføring (Faktiske)

30. mars 2009

Studiet fullført (Faktiske)

30. mars 2009

Datoer for studieregistrering

Først innsendt

18. desember 2008

Først innsendt som oppfylte QC-kriteriene

18. desember 2008

Først lagt ut (Anslag)

19. desember 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. august 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. august 2017

Sist bekreftet

1. august 2017

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Studiedata/dokumenter

  1. Studieprotokoll
    Informasjonsidentifikator: 111319
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Skjema for informert samtykke
    Informasjonsidentifikator: 111319
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Statistisk analyseplan
    Informasjonsidentifikator: 111319
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Datasettspesifikasjon
    Informasjonsidentifikator: 111319
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Annotert saksrapportskjema
    Informasjonsidentifikator: 111319
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Klinisk studierapport
    Informasjonsidentifikator: 111319
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Datasett for individuell deltaker
    Informasjonsidentifikator: 111319
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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