- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00828867
Single Dose Escalation First Time in Human PK Study
A Double-Blind, Parallel, Randomized, Placebo-Controlled, Single Dose Escalation First Time in Human Study to Investigate the Safety, Tolerability and Pharmacokinetics of Investigational Study Drug in Healthy Subjects
Studieoversikt
Status
Forhold
Intervensjon / Behandling
- Legemiddel: 100 mg GSK investigational drug
- Legemiddel: 200 mg GSK investigational drug
- Legemiddel: 400 mg GSK investigational drug
- Legemiddel: 800 mg GSK investigational drug
- Legemiddel: 1500 mg GSK investigational drug
- Legemiddel: 2000 mg GSK investigational drug
- Legemiddel: 800mg fed GSK investigational drug
- Legemiddel: 3000mg GSK investigational drug
- Legemiddel: 4000mg GSK investigational drug
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
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New South Wales
-
Randwick, New South Wales, Australia, 2031
- GSK Investigational Site
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Healthy
- male
- non-childbearling potential females
- Body weight greater than or equal to 50 kg (110 lbs) for men and greater than or equal to 45 kg (99 lbs) for women. Body mass index (BMI) between 18.5-29.9 kg/m2 inclusive.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
- QTcB < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block on Screening ECG
Exclusion Criteria:
- The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
- A 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 defined as:
an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males), or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). A standard unit is defined as 10g ethanol which is equivalent to 100mL wine, 250mL full strength beer, 470mL light beer, 30mL spirits
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the 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 dosing day.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- 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 as determined by positive [serum or urine] human chorionic gonadotropin (hCG) test at screening or prior to dosing.
- Lactating females.
- Subjects who have asthma or a history of asthma within the past 6 months.
- History of smoking or history of regular use of tobacco- or nicotine-containing products within 3 months prior to screening.
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice, pummelos, satsuma, ugli, tangerine, and tangelo, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Cohort 1
100mg
|
Andre navn:
|
Eksperimentell: Cohort 2
200mg
|
|
Eksperimentell: Cohort 3
400mg
|
|
Eksperimentell: Cohort 4
800mg
|
|
Eksperimentell: Cohort 5
1500mg
|
|
Eksperimentell: Cohort 6
2000mg
|
|
Eksperimentell: Cohort 7
800mg with food
|
|
Eksperimentell: Cohort 8
3000mg
|
|
Eksperimentell: Cohort 9
4000mg
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Safety parameters, adverse events, absolute values and changes over time of hematology, clinical chemistry, urinalysis, vital signs, electrocardiogram intervals, and ECG rhythm.
Tidsramme: Eighteen days
|
Eighteen days
|
Pharmacokinetic parameters following single dose administration: area under the plasma concentration curve AUC 0 to inf, AUC 0 to t, AUC 0 to 24, maximum observed concentration , time to maximum observed concentration , terminal half life .
Tidsramme: Two days, Three days (3000mg and 4000mg only)
|
Two days, Three days (3000mg and 4000mg only)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
AUC 0 to inf and Cmax following single dose administration for the assessment of dose proportionality
Tidsramme: Two days, Three days (3000mg and 4000mg only)
|
Two days, Three days (3000mg and 4000mg only)
|
Amount excreted of unchanged study drug and renal clearance
Tidsramme: Two days, Three days (3000mg and 4000mg only)
|
Two days, Three days (3000mg and 4000mg only)
|
AUC 0 to inf, AUC 0 to t, AUC 0 to 24, Cmax, tmax and tlag if deemed appropriate with and without high fat calorie meal
Tidsramme: Two days, Three days (3000mg and 4000mg only)
|
Two days, Three days (3000mg and 4000mg only)
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 111341
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Studiedata/dokumenter
-
Statistisk analyseplan
Informasjonsidentifikator: 111341Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Klinisk studierapport
Informasjonsidentifikator: 111341Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Annotert saksrapportskjema
Informasjonsidentifikator: 111341Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Skjema for informert samtykke
Informasjonsidentifikator: 111341Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Datasettspesifikasjon
Informasjonsidentifikator: 111341Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Datasett for individuell deltaker
Informasjonsidentifikator: 111341Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Studieprotokoll
Informasjonsidentifikator: 111341Informasjonskommentarer: 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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