HealthyPhase 1AZD6765 EEGNCT01130909
A Blinded, Four-Way Crossover in Healthy Subjects to Assess EEG After Administration of Ketamine, Placebo and AZD6765
A Phase 1 study testing AZD6765 and Ketamine in people with Healthy, run by AstraZeneca at 1 site in France.
Trial summary
This study will provide data to support preclinical to clinical translation by aligning preclinical and clinical efficacy assay with dose dependent changes in EEG. Read more about this study
- Who is it for?
- Ages 30 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AZD6765 and Ketamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- May 2010to Jan 2011
- Phase
- Phase 1
- 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 30 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18-30 Non-smoker for at least 4 weeks
Who cannot join
- Any clinically relevant acute or chronic disease
- History of substance abuse Hypersensitivity to ketamine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double-Blind, Four-way Cross-over Study in Healthy Subjects to Assess Quantitative Electroencephalography (qEEG) Parameters After the Administration of Ketamine, Two Doses of AZD6765 and Placebo
This study will provide data to support preclinical to clinical translation by aligning preclinical and clinical efficacy assay with dose dependent changes in EEG.
Read the detailed description
A Phase I, Randomized, Double-Blind, Four-way Cross-over Study in Healthy Subjects to Assess Quantitative Electroencephalography (qEEG) parameters after the administration of ketamine, two doses of AZD6765 and Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD6765Drug
75 mg
AZD6765Drug
150 mg
KetamineDrug
0.5 mg/kg
PlaceboDrug
125 mL sterile NaCl 0.9%
| Study group | Role | What they receive |
|---|---|---|
| AZD6765 75 mg | Experimental | Not described Receives: Drug: AZD6765 |
| AZD6765 150 mg | Experimental | Not described Receives: Drug: AZD6765 |
| Ketamine 0.5 mg/kg | Active comparator | Not described Receives: Drug: Ketamine |
| 125 mL sterile NaCl 0.9% | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
qEEG assessed through the gamma bands
Measured: Day 1 of each treatment period at Predose, 0.25h, 1h, 1.25h, 3h and 8h
Secondary outcomes (3)
Pupil Size - to assess the relationship between qEEG and pupil size
Measured: Day 1 of each treatment period at Predose, 0.25h, 1h, 1.25h, 3h, and 8h
Electronystagmography - to assess the relationship between qEEG and spontaneous nystagmus.
Measured: Day 1 of each treatment period at Predose, 1h, 3h, and 8h
Bond/Lader scales and eVAS - to assess the subject's alertness, calmness and contentment
Measured: Day 1 of each treatment period at Predose, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, and 8h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2010 (estimated)
- Study startMay 2010
- Primary completionJan 2011
- Study completionJan 2011
Why it stopped: The benefit of halting the study to analyze the available data outweighs the benefit of delaying the analysis to include data from remaining treatment periods
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Albena Patroneva, MD, Study director, AstraZenecaFrancine Santoro, Principal investigator, Forenap
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01130909
- Sponsor's protocol ID
- D2285M00008
- Acronym
- AZD6765 EEG
- Status last verified
- Oct 2014
- First submitted
- 19 May 2010
- Last updated
- 13 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Sanacora G, Smith MA, Pathak S, Su HL, Boeijinga PH, McCarthy DJ, Quirk MC. Lanicemine: a low-trapping NMDA channel blocker produces sustained antidepressant efficacy with minimal psychotomimetic adverse effects. Mol Psychiatry. 2014 Sep;19(9):978-85. doi: 10.1038/mp.2013.130. Epub 2013 Oct 15.
PubMed 24126931
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Four-way Cross-over Study in Healthy Subjects to Assess Quantitative Electroencephalography (qEEG) Parameters After the Administration of Ketamine, Two Doses of AZD6765 and Placebo
- ClinicalTrials.gov ID
- NCT01130909
- Acronym / sponsor ID
- AZD6765 EEG / D2285M00008
- Conditions
- Healthy
- Keywords
- Healthy, Effect of a single dose on gamma-band qEEG
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The benefit of halting the study to analyze the available data outweighs the benefit of delaying the analysis to include data from remaining treatment periods
- Enrolment
- 36 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 26 May 2010 (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.
This study will provide data to support preclinical to clinical translation by aligning preclinical and clinical efficacy assay with dose dependent changes in EEG.
Detailed description
A Phase I, Randomized, Double-Blind, Four-way Cross-over Study in Healthy Subjects to Assess Quantitative Electroencephalography (qEEG) parameters after the administration of ketamine, two doses of AZD6765 and Placebo
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AZD6765 75 mg | Experimental | Drug: AZD6765 |
| AZD6765 150 mg | Experimental | Drug: AZD6765 |
| Ketamine 0.5 mg/kg | Active comparator | Drug: Ketamine |
| 125 mL sterile NaCl 0.9% | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI 18-30 Non-smoker for at least 4 weeks
Key exclusion criteria (2 listed)
- Any clinically relevant acute or chronic disease
- History of substance abuse Hypersensitivity to ketamine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD676575 mg | Drug | AZD6765 75 mg |
| AZD6765150 mg | Drug | AZD6765 150 mg |
| Ketamine0.5 mg/kg | Drug | Ketamine 0.5 mg/kg |
| Placebo125 mL sterile NaCl 0.9% | Drug | 125 mL sterile NaCl 0.9% |
Primary outcome
qEEG assessed through the gamma bands
Time frame: Day 1 of each treatment period at Predose, 0.25h, 1h, 1.25h, 3h and 8h
3 secondary outcomes
Pupil Size - to assess the relationship between qEEG and pupil size
Time frame: Day 1 of each treatment period at Predose, 0.25h, 1h, 1.25h, 3h, and 8h
Electronystagmography - to assess the relationship between qEEG and spontaneous nystagmus.
Time frame: Day 1 of each treatment period at Predose, 1h, 3h, and 8h
Bond/Lader scales and eVAS - to assess the subject's alertness, calmness and contentment
Time frame: Day 1 of each treatment period at Predose, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, and 8h
Results and safety
The study was stopped early (reason given: The benefit of halting the study to analyze the available data outweighs the benefit of delaying the analysis to include data from remaining treatment periods). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2014.
- Derived from this study: PubMed 24126931Sanacora G, Smith MA, Pathak S, Su HL, Boeijinga PH, McCarthy DJ, Quirk MC. Lanicemine: a low-trapping NMDA channel blocker produces sustained antidepressant efficacy with minimal psychotomimetic adverse effects. Mol Psychiatry. 2014 Sep;19(9):978-85. doi: 10.1038/mp.2013.130. Epub 2013 Oct 15.
- D2285M00008 Clinical Study Report SynopsisLink provided by the sponsor.
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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.
Albena Patroneva, MD study director
AstraZeneca
Francine Santoro principal investigator
Forenap
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD6765 and Ketamine in people with Healthy, run by AstraZeneca at 1 site in France.
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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 13 Oct 2014. 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 France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The benefit of halting the study to analyze the available data outweighs the benefit of delaying the analysis to include data from remaining treatment periods). Results are not available in the source record.
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?
qEEG assessed through the gamma bands (time frame: Day 1 of each treatment period at Predose, 0.25h, 1h, 1.25h, 3h and 8h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01130909, which also lists 1 linked publication.
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 13 Oct 2014.