- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00743405
Safety, Tolerability and Pharmacokinetics of GSK1034702 in Healthy Subjects
18. juli 2017 opdateret af: GlaxoSmithKline
Single-blind, Randomised, Placebo Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1034702 in Healthy Subjects
This is a First Time in Human Study to assess the safety, tolerability and pharmacokinetics of single doses of GSK1034702 in healthy subjects.
It will be a single-blind, randomized, placebo-controlled, single oral dose, dose-rising, cross-over study in healthy male and female (of non-child bearing potential) subjects.
Subjects will be randomized into cohorts of 10 subjects and cohorts will be recruited until the pre-defined safety or PK stopping limits are reached.
Each subject will receive placebo and up to 4 doses of GSK1034702 in a randomized sequence on 5 separate study occasions.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
30
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
London, Det Forenede Kongerige, NW10 7NS
- GSK Investigational Site
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 55 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Healthy as determined by a responsible physician, based on a medical evaluation including own and familial medical history, physical examination, laboratory tests and cardiac monitoring.
- Male or female between 18 and 55 years of age.
- A female subject is eligible to participate if she is of non-childbearing potential
- Body weight > 50 kg and BMI within the range 19 - 29.9 kg/m2 (inclusive).
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Capable of reading, comprehending and writing English at a sufficient level to complete study-related materials.
- Demonstrates no evidence of mental impairment.
- No co-morbid Psychiatric Disorders as defined using the Mini International Neuropsychiatric Interview
Exclusion Criteria:
- A positive pre-study drug/alcohol screen.
- A positive pre-study Hepatitis B , Hepatitis C or HIV.
- History of regular alcohol consumption.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements .
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Pregnant females, females planning pregnancy or lactating females.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Subjects with a current or a history of psychiatric illness.
- Subjects with any history of suicidal attempts or behavior.
- Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products.
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice (and pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices) from 7 days prior to the first dose of study medication.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: Cohort 1
Subjects will be receive GSK1034702 0.5 milligram (mg) following the dose escalation plan
|
Oral or liquid
Til at matche GSK1034702
|
Andet: Cohort 2
Subjects will be receive GSK1034702 5 mg following the dose escalation plan
|
Oral or liquid
Til at matche GSK1034702
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
•Safety and tolerability determined by adverse events; ECG; Holter; blood pressure, heart rate, respiration rate; clinical laboratory evaluations, pupil size & temperature.•Blood concentrations of GSK1034702.
Tidsramme: 20 weeks
|
20 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Assessment of the Bond-Lader Visual Analogue Scale.
Tidsramme: 20 weeks
|
20 weeks
|
Assessment of exploratory PD markers: neuroendocrine markers, e.g. growth hormone.
Tidsramme: 20 weeks
|
20 weeks
|
Relationship between GSK1034702 plasma concentrations and safety/tolerability or exploratory PD endpoints with selected pharmacodynamic and safety parameters.
Tidsramme: 20 weeks
|
20 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
2. maj 2008
Primær færdiggørelse (Faktiske)
15. december 2008
Studieafslutning (Faktiske)
15. december 2008
Datoer for studieregistrering
Først indsendt
27. august 2008
Først indsendt, der opfyldte QC-kriterier
27. august 2008
Først opslået (Skøn)
28. august 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. juli 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. juli 2017
Sidst verificeret
1. juli 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 110623
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 .