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- Sperimentazione clinica NCT01713608
A Dose-escalation Study to Investigate Safety and Toleration of OZ439
12 marzo 2015 aggiornato da: Medicines for Malaria Venture
A Randomised, Placebo-controlled, Dose-escalation Study to Investigate Safety and Toleration of OZ439 OD for 3 Days to Healthy Male and Female Volunteers
A randomised, placebo-controlled, dose-escalation study to investigate safety and toleration of OZ439 OD for 3 days to healthy male and female volunteers. The study aims:
- To determine the safety and tolerability of ascending doses of OZ439 OD for three days.
- To assess pharmacokinetic parameters of ascending doses of OZ439 given OD.
- To identify the maximum tolerated dose of OZ439 administered.
Panoramica dello studio
Descrizione dettagliata
This study will be conducted in a randomised, placebo-controlled dose-escalation design with OZ439 OD administered with full fat milk for three days to healthy male and female subjects between 18 to 55 years of age, using features of an adaptive study design.
The study is expected to have three cohorts with a total of 36 healthy male and female subjects.
An additional two cohorts may be used if required.
The results of this study will inform the maximum tolerated exposure of OZ439 following OD dosing for three days in subjects who are not fasted.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
34
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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Croydon, Regno Unito, CR77YE
- Richmond Pharmacology Ltd
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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
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusions:
- healthy males or females of any race aged 18 - 55 years
- BMI of 18 - 30 kg/m2 inclusive at screening
- Agree to use acceptable methods of contraception if of childbearing potential
- Capable of understanding and complying with the requirements of the protocol and must have signed the informed consent form
- Females are either of child bearing potential or are confirmed as post-menopausal. Post-menopausal is defined as being amenorrheic for 12 months without an alternative medical cause with a screening FSH level ≥ 25.8 IU/L
Exclusions:
- Male subjects with female partner(s) who is (are) pregnant or lactating from the time of the first administration of study medication
- Clinically significant disease or any condition or disease that might affect drug absorption, distribution or excretion
- History of allergic reactions to artemisinin-based compounds or any other clinically relevant allergy to drugs or food
- Clinically relevant history of both soya and cow's milk intolerance/allergy
- Clinically significant abnormal laboratory, vital signs or other safety findings as determined by medical history, physical examination or other evaluations conducted at screening or on admission
- Electrocardiogram (ECG) abnormalities in the standard 12-lead ECG (at screening) and/or 24-hour 5 lead Holter ECG (at screening)
- Any abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes
- Prolonged QTcF >450 ms or shortened QTcF <340 ms, or family history of Long QT Syndrome
- History or current evidence of any clinically relevant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological, psychiatric, or other disease
- Positive results in any of the serology tests for Hepatitis B Surface Antigen (HbsAg), anti Hepatitis core antibody (anti HBc Ig G [and anti HBc IgM if IgG is positive], Hepatitis C antibodies (anti HCV), and HIV 1 and 2 antibodies (anti HIV 1/2)
- Confirmed positive results from urine drug screen (amphetamines, benzodiazepines, cocaine, cannabinoids, opiates, barbiturates, and methadone) or from the alcohol breath test at screening and on admission
- History or clinical evidence of alcohol or drug abuse. Alcohol abuse is defined as regular weekly intake of more than 21 units for males and 14 units for females; drug abuse is defined as compulsive, repetitive and/or chronic use of drugs or other substances with or without problems related to their use and/or where stopping or a reduction in dose will lead to withdrawal symptoms
- Is pregnant or lactating (female subjects who are of childbearing potential must have negative pregnancy tests at screening and admission)
- Mentally handicapped
- Participation in a drug trial within 90 days prior to first drug administration
- Use of any medication (incl. over-the-counter (OTC) medication) within 2 weeks prior to drug administration (Day 1) or within less than 10 times the elimination half-life of the respective drug, or anticipated concomitant medication during the treatment periods, (whichever is longer), including herbal, traditional and alternative medications. Excluding oral contraceptives (combination oestrogen/progesterone pills), injectable progesterone or subdermal implants. Limited amounts (4g/day for 2 days) of paracetamol will be permitted for the treatment of AEs
- Treatment with herbal supplements during the 7 days prior to drug administration, or use of vitamins during 48 hours prior to drug administration
- Is not permitted to use strong inhibitors and/or inducers of CYP450 within 21 days prior to the planned first drug administration
- Subjects have veins unsuitable for intravenous puncture or cannulation on either arm (e.g. veins that are difficult to locate, access or puncture veins with a tendency to rupture during or after puncture)
- Blood ALT, AST and bilirubin should be in the normal range at screening and on admission
- Donation of more than 500 mL of blood within 90 days prior to drug administration
- Subjects must be non-smokers for at least three months prior to first drug administration
- Any circumstances or conditions, which, in the opinion of the PI, may affect full participation in the trial or compliance with the protocol
- Legal incapacity or limited legal capacity at screening
- Subjects who are vegetarians, vegans or have any dietary restrictions conflicting with the study standardised menus
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: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: OZ439 Dose level 1 (300mg)
• Cohort 1 (12 subjects: 8 Active [A] and 4 on Placebo [P]) Active dose will consist of 300mg OZ439 drinking solution administered once daily for 3 days
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OZ439 x mg once daily for 3 days with milk
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Sperimentale: OZ439 Dose level 2
• Cohort 2 (12 subjects: 8 A, 4P).
Subjects on active will receive X amount of OZ439 (dose level to be determined based on safety and tolerability of previous dose level) drinking solution once daily for 3 days
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OZ439 x mg once daily for 3 days with milk
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Sperimentale: OZ439 dose level 3
Cohort 3 (12 subjects: 8 A, 4P).
Subjects on active will receive X amount of OZ439 (dose level to be determined based on safety and tolerability of previous dose level) drinking solution once daily for 3 days
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OZ439 x mg once daily for 3 days with milk
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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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OZ439 Cmax
Lasso di tempo: Blood for analysis of OZ439 will be collected at the following times: pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.
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OZ439 maximum measured plasma concentration
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Blood for analysis of OZ439 will be collected at the following times: pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.
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OZ439 AUCτ
Lasso di tempo: pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.
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OZ439 Area under the plasma concentration vs time curve from time zero to the time of the last quantifiable concentration t calculated using a log-linear trapezoidal method
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pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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OZ439 Tmax
Lasso di tempo: pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.
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Time to reach maximum measured OZ439 plasma concentration
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pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.
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OZ439 t½
Lasso di tempo: pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.
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OZ439 estimated terminal phase half life
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pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Fiona Macintyre, PhD, Medicines for Malaria Venture
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Collegamenti utili
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 2012
Completamento primario (Effettivo)
1 febbraio 2013
Completamento dello studio (Effettivo)
1 febbraio 2013
Date di iscrizione allo studio
Primo inviato
22 ottobre 2012
Primo inviato che soddisfa i criteri di controllo qualità
22 ottobre 2012
Primo Inserito (Stima)
25 ottobre 2012
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
23 marzo 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
12 marzo 2015
Ultimo verificato
1 marzo 2015
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- MMV_OZ439_12_005
- 2012-004187-22 (Numero EudraCT)
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 .
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