Study of Ketamine Administered Intravenously and by Sublingual Wafer

NCT01377831 | Completed DMC

• 1 other identifier: KET001
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the rate and extent of of absorption of racemic ketamine from sublingual wafer

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Bioavailability of a single 25 mg dose of sublingual (SL) ketamine

  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.

Secondary Outcomes (2)

• General clinical tolerability and safety

  24 hours post-dose for two dosing periods, which were separated by 7 days.

• Rate of disintegration

  5 minutes post-dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

8 Healthy Male Volunteers

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• iX Biopharma Ltd.: lead

Study Sites (1)

Pain and Anaesthesia Research Clinic (PARC), Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood will be drawn into Vacuette brand, lithium heparin separator tubes (green/yellow top).

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pual Rolan

  Pain and Anaesthesia Research Clinic - PARC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2011
• First Posted: June 21, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 10, 2015

Record last verified: 2015-03

Locations

AU (1)