- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00961779
Safety Study of NNZ-2566 in Healthy Female Subjects
A Phase I, Double-Blind, Randomized, Dose Escalation Study to Assess the Safety, Tolerability and PK of NNZ-2566 in Healthy Females, When Administered as a Loading Dose (10-Min), and as a Loading Dose Followed by a Maintenance Dose (72-Hr).
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
To obtain evidence of the safety of NNZ-2566 in healthy female volunteers, compared to placebo when administered as a 10 minute intravenous (i.v.) bolus infusion, and when administered as a 10-minute bolus infusion immediately followed by a continuous 72-hour maintenance infusion.
To determine the blood pharmacokinetics (PK) of an intravenous dose of NNZ-2566 in healthy female volunteers when administered as a 10-minute bolus infusion, and when administered as a 10-minute bolus followed by a continuous 72-hour maintenance infusion.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
-
-
Victoria
-
Melbourne, Victoria, Australia, 3004
- Nucleus Network
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Aged between 18 years and 50 years (inclusive).
- Females only.
- Weight 50 to 105 kg
- BMI of 18 to 30 kg/m2.
General Health: Healthy, determined by a medical history with particular attention to:
- a drug history identifying any known drug allergies and the presence of drug abuse;
- any chronic use of medication; and
- a thorough review of body systems. This will also be determined by having no clinically significant abnormal findings on physical examination, which includes an electrocardiogram (ECG), which in the opinion of the Investigator would jeopardize the safety of the subject or impact on the validity of the study results.
- Venous Access: Volunteers with adequate venous access in their left and right arm to allow collection of blood samples and drug administration.
- Language: Fluent in the English language.
- Informed Consent: Have voluntarily given written informed consent to participate in this study.
Exclusion Criteria:
- Pregnant and lactating females are excluded from participating in the study.
- History of allergy and/or hypersensitivity to any of the stated ingredients of the formulations.
- History of clinically significant gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, psychiatric disease or hematological disorders.
- Any history of asthma during the last 10 years.
- A creatinine clearance of less than 75 mL/min.
- Any predisposing condition that might interfere with the absorption, distribution, metabolism, and/or excretion of the investigational product.
- History of abnormal bleeding tendencies or thrombophlebitis unrelated to venepuncture or intravenous cannulation.
- History of Hepatitis B, a positive test for Hepatitis B surface antigen, a history of Hepatitis C, a positive test for Hepatitis C antibody, a history of HIV infection or demonstration of HIV antibodies.
- Pregnancy.
- Any evidence of organ dysfunction, or any clinically significant clinical laboratory value, including a liver function test (LFT) > 1.5 x upper limit of normal (ULN).
- Difficulty abstaining from alcohol during the 48 hours prior to dose administration and until completion of blood sampling at exit assessment.
- History of, or current evidence of, abuse of alcohol or any drug substance, licit or illicit, or positive urine drug screen for drugs of abuse.
- Difficulty in abstaining from any prescription medications for 14 days prior to dose administration and for the duration of the study.
- Difficulty in abstaining from over-the-counter (OTC) medications or herbal supplements for 14 days prior to dose administration and for the duration of the study, (with the exception of occasional analgesia, vitamin and other nutrient supplement use, at the discretion of the Investigator).
- Difficulty in abstaining from food and/or beverages that contain caffeine or other xanthines, (e.g., coffee, tea, cola and chocolate) during the 24 hours prior to dose administration and whilst confined at the clinical study facility.
- History of any psychiatric illness which may impair the ability to provide written informed consent.
- Poor protocol compliers or those unlikely to attend.
- Receipt of any drug as part of a research study within 30 days of initial dose administration in this study.
- Standard blood donation (usually 550 mL) within the 12-week period before dose administration.
- Unusual dietary habits and excessive or unusual vitamin intakes.
- Vaccination or immunizations within 30 days of initial dose administration.
- QT/QTc Exclusions i.e., a marked baseline prolongation of corrected QT interval > 450 ms in two ECGs, or a history of risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore placebo: Placebo (Normal saline infusion)
|
Normal saline infusion
Altri nomi:
|
Sperimentale: NNZ-2566
NNZ-2566 reconstituted in bicarbonate buffer and normal saline.
6/8 subjects in each cohort (5 cohort in total) to receive NNZ-2566 experimental treatment.
|
Glycyl-L-2-Methylprolyl-L-Glutamic Acid (NNZ-2566) supplied as a lyophilized powder (2g in 50mL vials) for reconstitution with bicarbonate buffer and normal saline.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Incidence of AEs and SAEs
Lasso di tempo: Through to Day 7 post end of study drug infusion or until resolved
|
Through to Day 7 post end of study drug infusion or until resolved
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Douglas J Wilson, MB ChB, PhD, Neuren Pharmaceuticals Ltd
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Neu-2566-HV-004
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
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 Lesioni cerebrali, traumatiche
-
University of PadovaCompletatoPropofol | Anestesia Brain MonitoringItalia
-
University of PadovaCompletato
-
University of PadovaReclutamentoAnestesia Brain MonitoringItalia
-
University of PadovaCompletato
-
University of PadovaCompletato
-
University of PadovaCompletatoPropofol | Anestesia Brain MonitoringItalia
-
University of PadovaCompletatoLidocaina | Anestesia Brain MonitoringItalia
-
University of Dublin, Trinity CollegeSconosciutoBrain Health Atleti d'élite in pensione
-
Assiut UniversityCompletatoMorfometria basata su Brain Voxel in ManiaEgitto