SchizophreniaPhase 1NCT01511510
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Repeated Doses of PF-04958242 in Healthy Volunteers
A Phase 1 study testing PF-04958242 in people with Schizophrenia, run by Biogen at 1 site in United States.
Trial summary
This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a number of ascending doses administered once daily for 14 days in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- PF-04958242
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Nov 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and/or female subjects of non-child bearing potential Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
- History of seizures or of a condition with risk of seizures
- Pregnant or nursing females, and females of child bearing potential
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
Official title: A Phase I, Randomized, Subject And Investigator Blind, Sponsor Open, Multiple Escalating Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-04958242 In Healthy Adult Volunteers
This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a number of ascending doses administered once daily for 14 days in healthy volunteers.
Read the detailed description
This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.
- Conditions
- Schizophrenia
- Being tested
- PF-04958242, Placebo
- Keywords
- PF-04958242, multiple dose, safety, schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04958242Drug
PF-04958242 0.05 mg oral solution Q24 hours for 14 days
PF-04958242Drug
PF-04958242 0.10 mg oral solution Q24 hours for 14 days
PF-04958242Drug
PF-04958242 0.15 mg oral solution Q24 hours for 14 days
PF-04958242Drug
PF-04958242 0.25 mg oral solution Q24 hours for 14 days
PlaceboDrug
Placebo oral solution Q24 hours for 14 days
| Study group | Role | What they receive |
|---|---|---|
| PF-04958242 | Experimental | Not described Receives: Drug: PF-04958242 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24 hours after dosing on Day 1
Measured: Day 1-Day 2
Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 4
Measured: Day 4
Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 7
Measured: Day 7
Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 48, 72, 120 hours after dosing on Day 14
Measured: Day 14-Day 18
Composite of urine Pharmacokinetics measured for 24 hours post-dose on Day 14
Measured: Day 14-Day 15
Secondary outcomes (3)
Drug Effect Questionaire Liking scale
Measured: Day 14
Digit Symbol Substitution Test
Measured: Day 14
Columbia Suicide Severity Rating Scale
Measured: Day 0-Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startJun 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by BiogenThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511510
- Sponsor's protocol ID
- B1701007
- Status last verified
- Nov 2019
- First submitted
- 19 Jul 2011
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Subject And Investigator Blind, Sponsor Open, Multiple Escalating Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-04958242 In Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01511510
- Acronym / sponsor ID
- B1701007
- Conditions
- Schizophrenia
- Keywords
- PF-04958242, multiple dose, safety, schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 18 Jan 2012 (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 aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a number of ascending doses administered once daily for 14 days in healthy volunteers.
Detailed description
This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF-04958242 | Experimental | Drug: PF-04958242 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male and/or female subjects of non-child bearing potential Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)
Key exclusion criteria (3 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
- History of seizures or of a condition with risk of seizures
- Pregnant or nursing females, and females of child bearing potential
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-04958242PF-04958242 0.05 mg oral solution Q24 hours for 14 days | Drug | PF-04958242 |
| PF-04958242PF-04958242 0.10 mg oral solution Q24 hours for 14 days | Drug | PF-04958242 |
| PF-04958242PF-04958242 0.15 mg oral solution Q24 hours for 14 days | Drug | PF-04958242 |
| PF-04958242PF-04958242 0.25 mg oral solution Q24 hours for 14 days | Drug | PF-04958242 |
| PlaceboPlacebo oral solution Q24 hours for 14 days | Drug | Placebo |
Primary outcome
Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24 hours after dosing on Day 1
Time frame: Day 1-Day 2
Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 4
Time frame: Day 4
Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 7
Time frame: Day 7
Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 48, 72, 120 hours after dosing on Day 14
Time frame: Day 14-Day 18
Composite of urine Pharmacokinetics measured for 24 hours post-dose on Day 14
Time frame: Day 14-Day 15
3 secondary outcomes
Drug Effect Questionaire Liking scale
Time frame: Day 14
Digit Symbol Substitution Test
Time frame: Day 14
Columbia Suicide Severity Rating Scale
Time frame: Day 0-Day 14
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 21 Nov 2019.
- 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.
Medical Director study director
Biogen
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 PF-04958242 in people with Schizophrenia, run by Biogen 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 1 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 21 Nov 2019. 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. 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 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?
Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24 hours after dosing on Day 1 (time frame: Day 1-Day 2). The study lists 5 primary outcomes in all. 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 Nov 2019.