PainNCT01377831
Study of Ketamine Administered Intravenously and by Sublingual Wafer
An observational study of Pain, run by iX Biopharma Ltd. at 1 site in Australia.
Trial summary
To determine the rate and extent of of absorption of racemic ketamine from sublingual wafer Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- How many people
- 8 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2011to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 8 Healthy Male Volunteers
Who may be able to join
- 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.
Who cannot join
- 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
Show all 27Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Pain and Anaesthesia Research Clinic (PARC), Royal Adelaide Hospital
Adelaide, South Australia, 5000
About this study
Official title: 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
Read the detailed description
- 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.
- Conditions
- Pain
- Medical subject headings
- Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours post-dose for two dosing periods, which were separated by 7 days.
Secondary outcomes (2)
General clinical tolerability and safety
Determined by using a range of objective and subjective parameters.
Measured: 24 hours post-dose for two dosing periods, which were separated by 7 days.
Rate of disintegration
Measured the apparent rate of disintegration of a single 25 mg sublingual wafer formulation of ketamine.
Measured: 5 minutes post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- iX Biopharma Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pual Rolan, Principal investigator, Pain and Anaesthesia Research Clinic - PARC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377831
- Sponsor's protocol ID
- KET001
- Status last verified
- Mar 2015
- First submitted
- 19 Jun 2011
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01377831
- Acronym / sponsor ID
- KET001
- Conditions
- Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- iX Biopharma Ltd.University, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 21 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the rate and extent of of absorption of racemic ketamine from sublingual wafer
Detailed description
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 8 Healthy Male Volunteers
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (27 listed)
- 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:
- Plasma AST, ALT and ALP tests in excess of 1.5 times the upper limit of normal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bioavailability of a single 25 mg dose of sublingual (SL) ketamine
Time frame: 24 hours post-dose for two dosing periods, which were separated by 7 days.
Bioavailability determined by evaluation and comparison of PK variables following SL and IV administration.
2 secondary outcomes
General clinical tolerability and safety
Time frame: 24 hours post-dose for two dosing periods, which were separated by 7 days.
Rate of disintegration
Time frame: 5 minutes post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pual Rolan principal investigator
Pain and Anaesthesia Research Clinic - PARC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by iX Biopharma Ltd. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioavailability of a single 25 mg dose of sublingual (SL) ketamine (time frame: 24 hours post-dose for two dosing periods, which were separated by 7 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2015.