- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00448890
Evaluation of Single and Repeat Doses of GSK729327 in Healthy Volunteers
14 ottobre 2010 aggiornato da: GlaxoSmithKline
Single-Blind, Randomised, Placebo-Controlled Two-Part Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Escalating Doses and Repeat Doses of GSK729327 in Healthy Volunteers
GSK729327 is a selective positive allosteric modulator of AMPA-type ionotropic glutamate receptors, exhibiting equivalent potency at all AMPA receptor subtypes.
On the basis of preclinical studies it is expected that this compound will improve cognitive measures in schizophrenic patients with acceptable safety.
This is a First Time in Human Study (FTIH) to assess the safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of GSK729327 in healthy volunteers.
The study will be conducted in 2 parts, with single doses being explored in Part A and multiple doses over 28 days in Part B. Part A will be a single blind, placebo controlled, single oral dose, dose-rising cross-over study in healthy male volunteers.
Subjects will be randomized into two cohorts with an alternate panel design.
There will be up to nine dosing sessions in total in order to investigate up to 7 different doses.
The initial dose will be 0.25 mg and subsequent doses will be determined based on the pharmacokinetic and safety results from the previous dose.
Part B will be a randomised, single blind, placebo-controlled, parallel group study of repeat oral dosing of GSK729327.
Up to 4 cohorts of 15 (12 subjects receiving active dose and 3 subjects receiving placebo) healthy male and females of (non-childbearing potential) volunteers will be enrolled in Part B.
Panoramica dello studio
Tipo di studio
Interventistico
Iscrizione (Effettivo)
79
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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Berlin, Germania, 14050
- GSK Investigational Site
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London, Regno Unito, SE1 1YR
- 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
Da 18 anni a 55 anni (Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Healthy male subjects between the ages of 18 and 55 years inclusive.
- Part B also includes healthy female subjects of non-child bearing potential.
- A normal ECG, physical examination and laboratory screen.
- Body weight >50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive.
- Signed and dated written informed consent prior to admission to the study.
Exclusion Criteria:
- Abuse of alcohol.
- A positive pre-study urine drug or alcohol screen.
- A positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody result at screening.
- History of DSM-IV alcohol and/or drug abuse or dependence.
- Consumption of grapefruit juice or grapefruit within 7 days prior to the first dose of study medication until final evaluation.
- Has received an investigational drug or has participated in any other research trial within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (which ever is longer) prior to the first dose of study medication.
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Use of prescription or non-prescription drugs within 4 weeks prior to the first dose of study medication until final evaluation. Where participation in study would result in donation of blood in excess of 500 ml within a 56 day period.
- History or presence of allergy to the study drug or drugs of this class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
- History or presence of clinically significant gastro-intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- History of cholecystectomy or biliary tract disease.
- History of regular use of tobacco- or nicotine-containing products within 6 months of the start of a study.
- An unwillingness of the male subject to use a condom/spermicide in addition to having their female partner use another form of contraception such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation if the woman could become pregnant from the time of the first dose of study medication until 90 days following administration of the last dose of study medication.QTc interval > 450 ms. Or an ECG that is not suitable for QT measurements.
- History of long QT syndrome (personal or family) or other cardiac conduction disorder, or other clinically significant cardiac disease.
- The subject has a history of myocardial infarction .The subject has a resting pulse rate <55 or >100 bpm OR a systolic blood pressure >140 or <100 OR a diastolic blood pressure >90 or <60.Current or past history of symptomatic orthostatic hypotension. The subject has any laboratory abnormality that in the investigator's judgment is considered to be clinically significant (even if not outside of specified ranges).History of known or suspected seizures, including infantile febrile, unexplained significant and recent loss of consciousness or history of significant head trauma with loss of consciousness or a family history (first degree relative) of epilepsy or seizures (fits).History or presence of psychiatric disease.
- History of suicidal attempts or behavior. Subjects who cannot complete the neuropsychological test battery despite having undergone the training sessions.
- Subject has a history of sleep problems in the last 3 months.
- The subject has clinically significant abnormalities in haematology, blood chemistry, ECG, or physical examination not resolved by the screening visit. Abnormal response to photic stimulation EEG. Abnormal prolactin or TSH or free T4 or free T3 at screening/baseline.
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: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore placebo: Placebo
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GSK729327 Matching placebo - Tablets
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Sperimentale: GSK729327
Dose escalation from 1.0mg to 6 mg.
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Tablets
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Safety and tolerability endpoints of AEs; EEG; ECGs; neurological assessments; vital signs and clinical laboratory values.Part A PK parameters of Cmax,AUC,t1/2,Tmax,Ae(0-t).Part B PK parameters of Cmax,Tmax,t1/2,AUC and accumulation ratio.
Lasso di tempo: throughout the study
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throughout the study
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Pharmacodynamic effects on Bond-Lader,Body Sway and EEG and the relationship of plasma levels of GSK729327 with pharmacodynamic parameters.Part B will also look atcognitive function,Polysomnography and LSEQ.
Lasso di tempo: throughout the study
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throughout the study
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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
1 novembre 2006
Completamento primario (Effettivo)
1 dicembre 2008
Completamento dello studio (Effettivo)
1 gennaio 2009
Date di iscrizione allo studio
Primo inviato
15 marzo 2007
Primo inviato che soddisfa i criteri di controllo qualità
15 marzo 2007
Primo Inserito (Stima)
19 marzo 2007
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
15 ottobre 2010
Ultimo aggiornamento inviato che soddisfa i criteri QC
14 ottobre 2010
Ultimo verificato
1 ottobre 2010
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- AM1107296
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 .