- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01377831
Study of Ketamine Administered Intravenously and by Sublingual Wafer
6. mars 2015 oppdatert av: 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
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
- 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
Observasjonsmessig
Registrering (Faktiske)
8
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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South Australia
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Adelaide, South Australia, Australia, 5000
- Pain and Anaesthesia Research Clinic (PARC), Royal Adelaide Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Mann
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
8 Healthy Male Volunteers
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Bioavailability of a single 25 mg dose of sublingual (SL) ketamine
Tidsramme: 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.
|
24 hours post-dose for two dosing periods, which were separated by 7 days.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
General clinical tolerability and safety
Tidsramme: 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.
|
Rate of disintegration
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Pual Rolan, Pain and Anaesthesia Research Clinic - PARC
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juni 2011
Primær fullføring (Faktiske)
1. juni 2011
Studiet fullført (Faktiske)
1. juni 2011
Datoer for studieregistrering
Først innsendt
19. juni 2011
Først innsendt som oppfylte QC-kriteriene
20. juni 2011
Først lagt ut (Anslag)
21. juni 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
10. mars 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. mars 2015
Sist bekreftet
1. mars 2015
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- Ket001
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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