- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01387217
GSK2018682 FTIH in Healthy Volunteers (P1A114070)
7. juni 2017 oppdatert av: GlaxoSmithKline
A Single-blind, Placebo-controlled, Two Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of GSK2018682 in Healthy Volunteers
This protocol describes the first administration of GSK2018682 to humans.
The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of GSK2018682.
The study will also provide preliminary evidence of the potential therapeutic dose-range by measuring the inhibitory effect of GSK2018682 on total lymphocyte counts.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This protocol describes the first administration of GSK2018682 to humans.
The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of GSK2018682.
The study will also provide preliminary evidence of the potential therapeutic dose-range by measuring the inhibitory effect of GSK2018682 on total lymphocyte counts.
Studietype
Intervensjonell
Registrering (Faktiske)
27
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
New South Wales
-
Randwick, New South Wales, Australia, 2031
- GSK Investigational Site
-
-
South Australia
-
Adelaide, South Australia, Australia, 5000
- 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 55 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters significantly outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. Subjects with lymphocyte counts outside the normal range should always be excluded from enrollment
- BMI within the range 19 - 28 kg/m2 (inclusive).
Exclusion Criteria:
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen.
- A positive test for HIV antibody.
- History of regular alcohol consumption
- Subjects with a history of, or examination suspicious for, skin cancer(s) including melanoma, basal cell or squamous cell carcinoma.
- Systolic blood pressure less than 95 mmHg or greater than 140 mmHg, or diastolic blood pressure less than or equal to 50 mmHg or greater than or equal to 95 mmHg.
- Symptomatic reduction in blood pressure after orthostatic challenge.
- Subjects with resting heart rate less than 45 beats per minute or greater than 90 beats per minute
Other criteria may apply as defined by the clinical protocol.
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: Part A
Part A will be used to confirm the prediction of GSK2018682 PK, assess its effects on lymphocytes, and monitor its safety profile in a single cohort (Cohort 1).
Cohort 1 will consist of 4 subjects and explore 4 doses of GSK2018682 in 4 study sessions.
In each session, three subjects will receive GSK2018682 and one subject will receive placebo.
Thus, when the cohort completes, each subject will receive placebo and 3 doses of GSK2018682.
|
GSK2018682
Matchet placebo
|
|
Eksperimentell: Part B
Part B will explore doses to refine the dose-response curve of GSK2018682 on lymphocyte suppression, as allowed by stopping criteria, in 1 or 2 cohorts of up to 15 subjects (Cohort 2 and Cohort 3).
In Part B, up to six single ascending doses of GSK2018682 and one dose of placebo will be investigated in up to 8 sessions.
|
GSK2018682
Matchet placebo
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
To investigate the safety and tolerability of single escalating oral doses of GSK2018682
Tidsramme: Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks
|
Adverse event and safety lab monitoring
|
Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks
|
|
To investigate effects of GSK2018682 on heart rate and blood pressure
Tidsramme: Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks
|
12 lead ECG and telemetry monitoring plus vital signs (systolic and diastolic blood blood pressures), heart rate, respiratory rate and temperature
|
Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks
|
|
To investigate the pharmacokinetics of single doses of GSK2018682
Tidsramme: Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks
|
Peak blood concentration, time of peak blood concentration, oral clearance, half life and AUC
|
Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks
|
|
Evaluate the effect of single escalating oral doses of GSK2018682 on lymphocytes (totals plus subsets)
Tidsramme: Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks
|
Reduction from baseline in lymphocyte counts obtained at different time points after dosing and at different dose levels
|
Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks
|
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)
21. mai 2010
Primær fullføring (Faktiske)
20. desember 2010
Studiet fullført (Faktiske)
20. desember 2010
Datoer for studieregistrering
Først innsendt
14. april 2011
Først innsendt som oppfylte QC-kriteriene
30. juni 2011
Først lagt ut (Anslag)
4. juli 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. juni 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. juni 2017
Sist bekreftet
1. juni 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 114070
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
-
Datasett for individuell deltaker
Informasjonsidentifikator: 114070Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Klinisk studierapport
Informasjonsidentifikator: 114070Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Studieprotokoll
Informasjonsidentifikator: 114070Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Statistisk analyseplan
Informasjonsidentifikator: 114070Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Annotert saksrapportskjema
Informasjonsidentifikator: 114070Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Skjema for informert samtykke
Informasjonsidentifikator: 114070Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Datasettspesifikasjon
Informasjonsidentifikator: 114070Informasjonskommentarer: 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. .