HealthyPhase 1NCT01244880
Effects Of PF-02545920 On Ketamine-Induced Abnormal Prefrontal Brain Response To Associative Learning In Healthy Subjects
A Phase 1 study testing Saline, PF-02545920 and Ketamine in people with Healthy, run by Pfizer at 3 sites in United States.
Trial summary
To evaluate whether PF-02545920 reduces the effects of ketamine on brain activation during causal learning as measured by fMRI compared to placebo in healthy human subjects, and to evaluate whether behavioral measures of abnormal causal learning under ketamine are reduced by treatment with PF 02545920. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Saline, PF-02545920 and Ketamine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2011to Aug 2012
- 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and/or female subjects between the ages of 21 and 45 years, inclusive. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs). (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
- Right handed as determined by handedness questionnaire.
- Able to read and write English as a primary language.
Who cannot join
- Female subjects who are pregnant or breastfeeding.
- Any evidence of significant psychosis-like symptoms.
- Known sensitivity to ketamine.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pfizer Investigational Site
New Haven, Connecticut, 06510
Pfizer Investigational Site
New Haven, Connecticut, 06519
Pfizer Investigational Site
New Haven, Connecticut, 06520
About this study
Official title: Subject And Investigator-Blinded, Sponsor-Open, Randomized, Single-Dose, Placebo-Controlled, 2-Way, 4-Period Crossover Study To Assess Effects Of PF-02545920 On Ketamine-Induced Aberrant Prefrontal Response To Associative Learning In Healthy Subjects
To evaluate whether PF-02545920 reduces the effects of ketamine on brain activation during causal learning as measured by fMRI compared to placebo in healthy human subjects, and to evaluate whether behavioral measures of abnormal causal learning under ketamine are reduced by treatment with PF 02545920.
Read the detailed description
The study was terminated on November 2, 2012 due to a reassessment of the likelihood of the study meeting its scientific objectives in light of data with the investigational drug obtained from another clinical study. The decision to terminate the trial was not based on any safety concerns.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineOther
Saline infusion for 56 minutes
PF-02545920Drug
PF-02545920 10 mg single dose
KetamineOther
Ketamine 0.23 mg/kg bolus over one min; and 0.58 mg/kg/hour maintenance for 56 minutes
PF-02545920 10 mg tablet
PF-02545920Drug
PF-02545920 10 mg tablet single dose
SalineOther
Saline infusion for 56 minutes
PlaceboOther
Placebo tablet single dose
KetamineOther
Ketamine 0.23 mg/kg bolus over one min; and 0.58 mg/kg/hour maintenance for 56 minutes
PlaceboOther
Placebo tablet single dose
| Study group | Role | What they receive |
|---|---|---|
| Saline/PF-02545920 | Experimental | Treatments are co-administered Receives: Other: Saline; Drug: PF-02545920 |
| Ketamine/PF-02545920 | Experimental | Treatments are co-administered Receives: Other: Ketamine; Drug: PF-02545920 |
| Saline/Placebo | Placebo comparator | Treatments are co-administered Receives: Other: Saline; Other: Placebo |
| Ketamine/Placebo | Experimental | Treatments are co-administered Receives: Other: Ketamine; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lateral prefrontal cortex activation as measured by functional MRI (fMRI) BOLD imaging during causal learning and working memory tasks
Measured: Day 1 of each treatment period
Secondary outcomes (5)
Lateral prefrontal cortex activation during causal learning and working memory tasks as measured by arterial spin labelling imaging
Measured: Day 1 of each treatment period
Causal learning task prediction error score for stimulus/outcome associations across 3 stages of learning and expectancy violation
Measured: Day 1 of each treatment period
N-back working memory task number correct
Measured: Day 1 of each treatment period
Positive and Negative Syndrome Scale (PANSS) positive and negative subscale total score
Measured: Day 1 of each treatment period
Clinician administered dissociative states scale (CADSS) total score
Measured: Day 1 of each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startApr 2011
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: See termination reason in detailed description.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01244880
- Sponsor's protocol ID
- A8241014
- Status last verified
- Mar 2014
- First submitted
- 5 Nov 2010
- Last updated
- 21 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subject And Investigator-Blinded, Sponsor-Open, Randomized, Single-Dose, Placebo-Controlled, 2-Way, 4-Period Crossover Study To Assess Effects Of PF-02545920 On Ketamine-Induced Aberrant Prefrontal Response To Associative Learning In Healthy Subjects
- ClinicalTrials.gov ID
- NCT01244880
- Acronym / sponsor ID
- A8241014
- Conditions
- Healthy
- Keywords
- PF-02545920, ketamine, fMRI, associative Learning
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 19 Nov 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.
To evaluate whether PF-02545920 reduces the effects of ketamine on brain activation during causal learning as measured by fMRI compared to placebo in healthy human subjects, and to evaluate whether behavioral measures of abnormal causal learning under ketamine are reduced by treatment with PF 02545920.
Detailed description
The study was terminated on November 2, 2012 due to a reassessment of the likelihood of the study meeting its scientific objectives in light of data with the investigational drug obtained from another clinical study. The decision to terminate the trial was not based on any safety concerns.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Saline/PF-02545920 | Experimental | Other: Saline, Drug: PF-02545920Treatments are co-administered |
| Ketamine/PF-02545920 | Experimental | Other: Ketamine, Drug: PF-02545920Treatments are co-administered |
| Saline/Placebo | Placebo comparator | Other: Saline, Other: PlaceboTreatments are co-administered |
| Ketamine/Placebo | Experimental | Other: Ketamine, Other: PlaceboTreatments are co-administered |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and/or female subjects between the ages of 21 and 45 years, inclusive. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs). (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
- Right handed as determined by handedness questionnaire.
- Able to read and write English as a primary language.
Key exclusion criteria (3 listed)
- Female subjects who are pregnant or breastfeeding.
- Any evidence of significant psychosis-like symptoms.
- Known sensitivity 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 |
|---|---|---|
| SalineSaline infusion for 56 minutes | Other | Saline/PF-02545920 |
| PF-02545920PF-02545920 10 mg single dose | Drug | Saline/PF-02545920 |
| KetamineKetamine 0.23 mg/kg bolus over one min; and 0.58 mg/kg/hour maintenance for 56 minutes PF-02545920 10 mg tablet | Other | Ketamine/PF-02545920 |
| PF-02545920PF-02545920 10 mg tablet single dose | Drug | Ketamine/PF-02545920 |
| SalineSaline infusion for 56 minutes | Other | Saline/Placebo |
| PlaceboPlacebo tablet single dose | Other | Saline/Placebo |
| KetamineKetamine 0.23 mg/kg bolus over one min; and 0.58 mg/kg/hour maintenance for 56 minutes | Other | Ketamine/Placebo |
| PlaceboPlacebo tablet single dose | Other | Ketamine/Placebo |
Primary outcome
Lateral prefrontal cortex activation as measured by functional MRI (fMRI) BOLD imaging during causal learning and working memory tasks
Time frame: Day 1 of each treatment period
5 secondary outcomes
Lateral prefrontal cortex activation during causal learning and working memory tasks as measured by arterial spin labelling imaging
Time frame: Day 1 of each treatment period
Causal learning task prediction error score for stimulus/outcome associations across 3 stages of learning and expectancy violation
Time frame: Day 1 of each treatment period
N-back working memory task number correct
Time frame: Day 1 of each treatment period
Positive and Negative Syndrome Scale (PANSS) positive and negative subscale total score
Time frame: Day 1 of each treatment period
Clinician administered dissociative states scale (CADSS) total score
Time frame: Day 1 of each treatment period
Results and safety
The study was stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2014.
- To obtain contact information for a study center near you, click here.Link 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.
Pfizer CT.gov Call Center study director
Pfizer
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Saline, PF-02545920 and Ketamine in people with Healthy, run by Pfizer at 3 sites in United States.
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 3 inclusion and 3 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 21 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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: See termination reason in detailed description.). 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?
Lateral prefrontal cortex activation as measured by functional MRI (fMRI) BOLD imaging during causal learning and working memory tasks (time frame: Day 1 of each treatment period). 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 21 Mar 2014.