- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02201303
Evaluation of Danirixin (GSK1325756) Inhibition of CD11b Cell Surface Expression
5 maggio 2017 aggiornato da: GlaxoSmithKline
A Single-Center In Vitro Study to Evaluate GSK1325756 Inhibition of CD11b Cell Surface Expression in Healthy Adults and Respiratory Syncytial Virus-Infected Children <2 Years (200591)
This study is to determine danirixin (GSK1325756) concentrations required to inhibit neutrophil activation in blood obtained from Respiratory Syncytial Virus (RSV)-infected children <2 years and healthy adults.
The study will evaluate differences in neutrophil activation between RSV-infected children <2 years and healthy adults with escalating concentrations of Chemokine (C-X-C motif) Ligand 1 (CXCL1) and danirixin to determine if RSV-infected children and adult neutrophils are similarly activated by CXCL1 and inhibited by danirixin.
This study will guide dose prediction to inhibit specific percentages of neutrophils in future pediatric RSV-infection studies.
This single-center, in vitro study will consist of 2 parts.
Approximately 24 subjects will be enrolled, including 12 healthy adults and 12 RSV-infected children <2 years.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
40
Fase
- Fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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New York
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Syracuse, New York, Stati Uniti, 13210
- GSK Investigational Site
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Non più vecchio di 64 anni (Bambino, Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
Healthy Adults
- Male/females aged between 18 and 64 years of age inclusive, at the time of signing the informed consent
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history and physical examination. A subject with a clinical abnormality parameter(s) which is not specifically listed in the inclusion or exclusion criteria, may be included only if the Investigator in consultation with the GSK Medical Monitor agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Body weight >= 45 kilograms (kg) and body mass index (BMI) within the range 18.5-32 kg/meter^2 (inclusive).
- A female subject is eligible to participate if she is not known to be pregnant by history or delivered within the past 3 months.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
RSV Infected Children
- Male/females aged <2 years, at the time of parent(s)/legal guardian(s) signing the informed consent.
- Healthy, except for current RSV-infection, as determined by a responsible and experienced physician, based on a medical evaluation including medical history and physical examination. A subject with a clinical abnormality parameter(s) which is not specifically listed in the inclusion or exclusion criteria, may be included only if the Investigator in consultation with the GSK Medical Monitor agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Body weight >= 3.5 kg
- Documented RSV-infection, either by RSV-antigen or RSV-PCR
- RSV-infection clinical symptom onset within 5 days of blood draw based on parent(s)/guardian(s) history.
- Parent(s)/legal guardian(s) of child capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Exclusion Criteria:
Healthy Adults
- Any clinical infection within the past 14 days per subject's history.
- Acute or chronic infectious/inflammatory diseases by history, including but not limited to, hepatitis B, hepatitis C, human immuno virus (HIV), inflammatory bowel disease, liver / biliary disease, pancreatitis, arthritis.
- Receiving systemic anti-inflammatory or immune modulating medications, including but not limited to, non-steroidal anti-inflammatory (NSAIDS) and glucocorticoids, within the past 14 days. All other medications are permitted.
- Any alcoholic beverage within 24 hours of blood collection and history of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 gram (g) of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
- Current smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- Strenuous exercise within 48 hours prior to the blood collection.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to signing the informed consent in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
RSV Infected Children
- A Child in Care: A child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. A child in care can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. A child in care does not include a child who is adopted or has an appointed legal guardian.
- Any clinical infection, besides current RSV infection, within the past 14 days per subject's history
- Acute or chronic infectious/inflammatory diseases by history, including but not limited to, hepatitis B, hepatitis C, HIV, liver / biliary disease, pancreatitis
- Receiving systemic anti-inflammatory or immune modulating medications, including but not limited to, NSAIDS and glucocorticoids, within the past 14 days. All other medications are permitted.
- Past medical history including prematurity <37 weeks, congenital heart disease, chronic lung disease, or immunodeficiency.
- Where participation in the study would result in withdrawal of blood or blood products in excess of 2 mL/kg for 24 hours before or after the study period.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to parent(s)/guardian(s) signing the informed consent in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Part 1
Blood sample will be collected from the RSV-infected children <2 years and healthy adults participants.
Escalating concentrations of CXCL1 will be added to whole blood in vitro and CD11b up regulation on peripheral blood neutrophils will be analyzed
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Escalating concentrations of CXCL1 will be added to whole blood in vitro.
A CXCL1/CD11b upregulation concentration response curve will determine the concentration to be used in Part 2.
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Sperimentale: Part 2
Blood sample will be collected from the RSV-infected children <2 years and healthy adults participants.
Escalating concentrations of danirixin will be added to whole blood in vitro with a fixed concentration of CXCL1 to determine inhibition of CD11b expression on peripheral blood neutrophils
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Escalating concentrations of CXCL1 will be added to whole blood in vitro.
A CXCL1/CD11b upregulation concentration response curve will determine the concentration to be used in Part 2.
Powdered form for in-vitro administration to blood sample
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Percent inhibition of Chemokine Ligand (CXCL1)-induced Cluster of Differentiation 11b expression on peripheral blood neutrophils in RSV-infected children <2 years and healthy adults after in vitro incubation with escalating concentrations of danirixin
Lasso di tempo: Day 1
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Blood (1.5 milliliter [mL]) will be collected from a peripheral vein via indwelling catheter or direct venepuncture.
Escalating concentrations of danirixin (0.03-100 micromoles) will be added to whole blood in vitro with a fixed concentration of CXCL1 to determine inhibition of Cluster of Differentiation 11b (CD11b) expression on peripheral blood neutrophils analyzed by Fluorescence-Activated Cell sorting (FACs).
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Day 1
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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CD11b upregulation on peripheral blood neutrophils in RSV-infected children <2 years and healthy adults after in vitro incubation with escalating concentrations of CXCL1
Lasso di tempo: Day 1
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Blood (1.0 mL) will be collected from a peripheral vein via indwelling catheter or direct venepuncture.
Escalating concentrations of CXCL1 will be added to whole blood in vitro and CD11b upregulation on peripheral blood neutrophils will be analyzed by FACS
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Day 1
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Differences in percent inhibition of CXCL1-induced CD11b expression on peripheral blood neutrophils in RSV-infected children <2 years and healthy adults after in vitro incubation with escalating concentrations of danirixin
Lasso di tempo: Day 1
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Inhibition of CD11b upregulation will be evaluated to determine if there is a similar concentration-response relationship between healthy adults and RSV-infected children
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Day 1
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
13 gennaio 2014
Completamento primario (Effettivo)
2 luglio 2015
Completamento dello studio (Effettivo)
2 luglio 2015
Date di iscrizione allo studio
Primo inviato
9 gennaio 2014
Primo inviato che soddisfa i criteri di controllo qualità
24 luglio 2014
Primo Inserito (Stima)
28 luglio 2014
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
9 maggio 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
5 maggio 2017
Ultimo verificato
1 maggio 2017
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 200591
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su CXCL1
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