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- Klinische proef NCT01377831
Study of Ketamine Administered Intravenously and by Sublingual Wafer
6 maart 2015 bijgewerkt door: iX Biopharma Ltd.
An Open Label, Two Way Crossover Study to Evaluate the Bioavailability and Clinical Tolerability of a Novel Sublingual Wafer Formulation of Ketamine in Healthy Male Volunteers
To determine the rate and extent of of absorption of racemic ketamine from sublingual wafer
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
- To determine the apparent rate of disintegration of the sublingual wafer
- To determine the overall clinical tolerability of ketamine when administered as a single dose via the sublingual route. Tolerability will be assessed using a range of objective and subjective parameters as assessed using modified Likert and Bond and Lader scales.
Studietype
Observationeel
Inschrijving (Werkelijk)
8
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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South Australia
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Adelaide, South Australia, Australië, 5000
- Pain and Anaesthesia Research Clinic (PARC), Royal Adelaide Hospital
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 65 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Mannelijk
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
8 Healthy Male Volunteers
Beschrijving
Inclusion Criteria:
- Adult males aged 18-65 years.
- Good general health without clinically significant renal, hepatic, cardiac or respiratory disease, as determined by the Principal Investigator.
- Good general mental health as determined by scores on the Symptom Checklist-90-R (SCL-90-R®), a screening instrument which evaluates a broad range of psychological problems and symptoms of psychopathology.
- Agree to and be capable of signing an Informed Consent Form.
- Have suitable venous access for blood sampling.
- BMI within the range of 19-30 kg/m2.
Exclusion Criteria:
- Renal impairment as evidenced by estimated creatinine clearance (CrCl), measured by the Cockcroft-Gault method, of less than 90 mL/min.
- Have a laboratory value at the Screening Visit that is outside the normal range, unless it is judged by the Investigator as not clinically significant after appropriate evaluation.
- A score of more than two standard deviations from the mean on any of the key nine scales in the SCL-90-R ®
Any medical condition that in the opinion of the Investigator may adversely impact on the participant's ability to complete the study, including but not limited to:
- History of cerebral trauma or stroke
- History of seizure or epilepsy
- Hyperthyroidism
- Recent clinically significant URTI (within two weeks of Day 1) or respiratory infection
- History of Myocardial Infarction or clinically significant cardiac disease including cardiac arrhythmia.
- Poorly controlled hypertension - as assessed by the Principal Investigator.
- Clinically significant history of asthma requiring regular supportive or preventative therapy (childhood asthma that has resolved >5 years previously may be suitable for inclusion at the discretion of the Investigator.
- Glaucoma
- Plasma AST, ALT and ALP tests in excess of 1.5 times the upper limit of normal.
- History of severe allergic or anaphylactic drug-related reactions.
- History of hypersensitivity to ketamine or any of its excipients.
- Current (within the last six months) clinically significant psychiatric disorder including anxiety, psychosis or depression.
- Concurrent use of other medication on a regular or daily basis including but not limited to, theophylline, benzodiazepines, thyroxine, sedatives or anti-anxiolytics.
- Participation in another clinical trial of an investigational agent within 30 days of study entry.
- Known history of past or present infection with hepatitis C virus (HCV), hepatitis B or human immunodeficiency virus (HIV).
- Clinically significant abnormal ECG (12-lead) at the screening visit or prior to dosing on Day 1, as determined by the Investigator.
- Participants who have a marked prolongation of the QT corrected (QTc) interval (i.e., repeated demonstration of a QTc >430 msec for males) at screening or prior to dosing on Day 1 in either study period will not be allowed to continue in the study.
- Significant history of illicit drug or alcohol use or abuse (as determined by the Principal Investigator).
- Any alcohol use within 24 hours prior to dosing on Day 1 in each of the study periods.
- Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the participant returning for follow-up visits on schedule.
- Blood donation (1 unit or more) within 1 month prior to the screening visit.
- Current or previous tobacco user (within 12 months prior to Day 1) .
- Planned surgical procedure requiring general anaesthesia during the study period and within two weeks of study completion
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Bioavailability of a single 25 mg dose of sublingual (SL) ketamine
Tijdsspanne: 24 hours post-dose for two dosing periods, which were separated by 7 days.
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Bioavailability determined by evaluation and comparison of PK variables following SL and IV administration.
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24 hours post-dose for two dosing periods, which were separated by 7 days.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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General clinical tolerability and safety
Tijdsspanne: 24 hours post-dose for two dosing periods, which were separated by 7 days.
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Determined by using a range of objective and subjective parameters.
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24 hours post-dose for two dosing periods, which were separated by 7 days.
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Rate of disintegration
Tijdsspanne: 5 minutes post-dose
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Measured the apparent rate of disintegration of a single 25 mg sublingual wafer formulation of ketamine.
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5 minutes post-dose
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Pual Rolan, Pain and Anaesthesia Research Clinic - PARC
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juni 2011
Primaire voltooiing (Werkelijk)
1 juni 2011
Studie voltooiing (Werkelijk)
1 juni 2011
Studieregistratiedata
Eerst ingediend
19 juni 2011
Eerst ingediend dat voldeed aan de QC-criteria
20 juni 2011
Eerst geplaatst (Schatting)
21 juni 2011
Updates van studierecords
Laatste update geplaatst (Schatting)
10 maart 2015
Laatste update ingediend die voldeed aan QC-criteria
6 maart 2015
Laatst geverifieerd
1 maart 2015
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- Ket001
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .