HealthyPhase 1NCT01092845
Study To Establish The Effects Of PF-04457845 On Sleep In Healthy Volunteers
A Phase 1 study of Healthy and Sleep, run by Pfizer at 1 site in United States.
Trial summary
PF-04457845 has been shown to temporarily decrease the dream (REM) period of sleep in rats, which suggests that PF-04457845 is active in rat's brains. This study is designed to see whether this is also the case in man. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Jun 2010
- 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects between the ages of 18 and 55 years
- Body Mass Index (BMI) between 17.5 and 30.5 kg/m2
- Total body weight >50 kg
Who cannot join
- History of any active sleep disorder
- History of any sleep or circadian rhythm sleep disorder including RLS, narcolepsy, sleep apnea, phase advance or delay syndromes within the past 5 years
- Currently on or planning to be involved in night or rotating shift work or traveling across more than four time zones in 14 days prior to screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
New York, New York, 10019
About this study
Official title: Double-Blind, Randomized, Multiple-Dose, Placebo-Controlled, 2-Way Crossover Study To Study Effects of PF-04457845 On Polysomnographic Endpoints In Healthy Volunteers
PF-04457845 has been shown to temporarily decrease the dream (REM) period of sleep in rats, which suggests that PF-04457845 is active in rat's brains. This study is designed to see whether this is also the case in man.
- Being tested
- PF-04457845 / matched placebo
- Keywords
- Double-Blind, Randomized, Placebo-Controlled, 2-Way Crossover, Polysomnographic Endpoints
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04457845 / matched placeboDrug
PF-04457845 4 mg tablet once daily / matched placebo
PF-04457845 / matched placeboDrug
PF-04457845 4 mg tablet once daily / matched placebo
| Study group | Role | What they receive |
|---|---|---|
| PF-04457845 followed by placebo | Experimental | Not described Receives: Drug: PF-04457845 / matched placebo |
| Placebo followed by PF-04457845 | Experimental | Not described Receives: Drug: PF-04457845 / matched placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of total sleep time spent in REM (ie, time spent in REM/total sleep time)
Measured: 3 days
Secondary outcomes (13)
Minutes of REM sleep time
Measured: 3 days
Percentage of total sleep time spent in Stage 1 sleep
Measured: 3 days
Percentage of total sleep time spent in Stage 2 sleep
Measured: 3 days
Percentage of total sleep time spent in Stage 3-4 sleep
Measured: 3 days
Total sleep time
Measured: 3 days
Wake after sleep onset (sum of wake time during sleep and prior to final awakening) and wake time after sleep) (WASO)
Measured: 3 days
Number of arousals after sleep onset (NASO)
Measured: 3 days
Latency to persistent sleep
Measured: 3 days
Plasma concentrations of PF-04457845
Measured: 3 days
Plasma concentrations of fatty acid amides (N-arachidonyl ethanolamine (anandamide, AEA), palmitoylethanolamide (PEA), oleoylethanolamide (OEA) and linoleoyl ethanolamine (LEA))
Measured: 3 days
Beta-band spectral power (qEEG) measured with eyes open and eyes closed while subjects are awake immediately before lights off for each PSG
Measured: 3 days
Beta-band spectral power (qEEG) measured with eyes open and eyes closed while subjects are awake immediately after lights on for each PSG
Measured: 3 days
Beta-band spectral power (qEEG) measured while subjects are asleep during the sleep onset period (SOP) and first 3 periods of NREM sleep
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2010
- Study completionJun 2010
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092845
- Sponsor's protocol ID
- B0541010
- Status last verified
- Nov 2018
- First submitted
- 23 Mar 2010
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Randomized, Multiple-Dose, Placebo-Controlled, 2-Way Crossover Study To Study Effects of PF-04457845 On Polysomnographic Endpoints In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01092845
- Acronym / sponsor ID
- B0541010
- Keywords
- Double-Blind, Randomized, Placebo-Controlled, 2-Way Crossover, Polysomnographic Endpoints
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 25 Mar 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.
PF-04457845 has been shown to temporarily decrease the dream (REM) period of sleep in rats, which suggests that PF-04457845 is active in rat's brains. This study is designed to see whether this is also the case in man.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF-04457845 followed by placebo | Experimental | Drug: PF-04457845 / matched placebo |
| Placebo followed by PF-04457845 | Experimental | Drug: PF-04457845 / matched placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subjects between the ages of 18 and 55 years
- Body Mass Index (BMI) between 17.5 and 30.5 kg/m2
- Total body weight >50 kg
Key exclusion criteria (3 listed)
- History of any active sleep disorder
- History of any sleep or circadian rhythm sleep disorder including RLS, narcolepsy, sleep apnea, phase advance or delay syndromes within the past 5 years
- Currently on or planning to be involved in night or rotating shift work or traveling across more than four time zones in 14 days prior to screening
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 |
|---|---|---|
| PF-04457845 / matched placeboPF-04457845 4 mg tablet once daily / matched placebo | Drug | PF-04457845 followed by placebo |
| PF-04457845 / matched placeboPF-04457845 4 mg tablet once daily / matched placebo | Drug | Placebo followed by PF-04457845 |
Primary outcome
Percentage of total sleep time spent in REM (ie, time spent in REM/total sleep time)
Time frame: 3 days
13 secondary outcomes
Minutes of REM sleep time
Time frame: 3 days
Percentage of total sleep time spent in Stage 1 sleep
Time frame: 3 days
Percentage of total sleep time spent in Stage 2 sleep
Time frame: 3 days
Percentage of total sleep time spent in Stage 3-4 sleep
Time frame: 3 days
Total sleep time
Time frame: 3 days
Wake after sleep onset (sum of wake time during sleep and prior to final awakening) and wake time after sleep) (WASO)
Time frame: 3 days
Number of arousals after sleep onset (NASO)
Time frame: 3 days
Latency to persistent sleep
Time frame: 3 days
Plasma concentrations of PF-04457845
Time frame: 3 days
Plasma concentrations of fatty acid amides (N-arachidonyl ethanolamine (anandamide, AEA), palmitoylethanolamide (PEA), oleoylethanolamide (OEA) and linoleoyl ethanolamine (LEA))
Time frame: 3 days
Beta-band spectral power (qEEG) measured with eyes open and eyes closed while subjects are awake immediately before lights off for each PSG
Time frame: 3 days
Beta-band spectral power (qEEG) measured with eyes open and eyes closed while subjects are awake immediately after lights on for each PSG
Time frame: 3 days
Beta-band spectral power (qEEG) measured while subjects are asleep during the sleep onset period (SOP) and first 3 periods of NREM sleep
Time frame: 3 days
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 4 Dec 2018.
- 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
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 of Healthy and Sleep, run by Pfizer at 1 site 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: finished, as of the sponsor's last update on 4 Dec 2018. 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 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. 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 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?
Percentage of total sleep time spent in REM (ie, time spent in REM/total sleep time) (time frame: 3 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 4 Dec 2018.