GSK2018682 FTIH in Healthy Volunteers (P1A114070)
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
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Fase
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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New South Wales
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Randwick, New South Wales, Australia, 2031
- GSK Investigational Site
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South Australia
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Adelaide, South Australia, Australia, 5000
- GSK Investigational Site
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Separare
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
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Sperimentale: 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.
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GSK2018682
Placebo abbinato
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Sperimentale: 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.
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GSK2018682
Placebo abbinato
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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To investigate the safety and tolerability of single escalating oral doses of GSK2018682
Lasso di tempo: 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
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Adverse event and safety lab monitoring
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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
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To investigate effects of GSK2018682 on heart rate and blood pressure
Lasso di tempo: 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
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12 lead ECG and telemetry monitoring plus vital signs (systolic and diastolic blood blood pressures), heart rate, respiratory rate and temperature
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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
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To investigate the pharmacokinetics of single doses of GSK2018682
Lasso di tempo: 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
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Peak blood concentration, time of peak blood concentration, oral clearance, half life and AUC
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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
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Evaluate the effect of single escalating oral doses of GSK2018682 on lymphocytes (totals plus subsets)
Lasso di tempo: 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
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Reduction from baseline in lymphocyte counts obtained at different time points after dosing and at different dose levels
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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
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Collaboratori e investigatori
Sponsor
Sponsor
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
Completamento primario (Effettivo)
Completamento primario
Completamento dello studio (Effettivo)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- 114070
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Dati/documenti di studio
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Set di dati del singolo partecipante
Identificatore informazioni: 114070Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Rapporto di studio clinico
Identificatore informazioni: 114070Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Protocollo di studio
Identificatore informazioni: 114070Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Piano di analisi statistica
Identificatore informazioni: 114070Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Modulo di segnalazione del caso annotato
Identificatore informazioni: 114070Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Modulo di consenso informato
Identificatore informazioni: 114070Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Specifica del set di dati
Identificatore informazioni: 114070Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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 .