HealthyPhase 1NCT01959594
A Study To Observe Safety And Blood Concentrations Of PF-06412562 During And Following The Oral Administration Of Multiple Doses Of PF-06412562 In Healthy Adult Volunteers
A Phase 1 study testing 3 mg PF-06412562, 10 mg PF-06412562 and 25 mg PF-06412562 in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
This study is designed to evaluate the safety and plasma concentrations of PF-06412562 in healthy volunteers following three times daily oral dosing of PF-06412562 for 14 days Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 3 mg PF-06412562, 10 mg PF-06412562 and 25 mg PF-06412562
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Mar 2014
- 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 female subjects of non-childbearing potential and/or male subjects between the ages of 18 and 55 years, inclusive (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).
- 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 (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
Official title: Phase 1, Double Blind, Sponsor Open, Randomized, Placebo Controlled, Dose Escalation, Parallel Group Study To Investigate The Safety, Tolerability And Pharmacokinetics Of Repeat Doses Of PF-06412562 In Healthy Subjects
This study is designed to evaluate the safety and plasma concentrations of PF-06412562 in healthy volunteers following three times daily oral dosing of PF-06412562 for 14 days
- Conditions
- Healthy
- Being tested
- 3 mg PF-06412562, 10 mg PF-06412562, 25 mg PF-06412562, PF-06412562 TBD mg
- Keywords
- multiple doses, pharmacokinetics, safety, tolerability, healthy volunteers, steady state, cognitive impairment associated with schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 mg PF-06412562Drug
oral dosing of 3 mg PF-06412562 tablets three times a day for 14 days
10 mg PF-06412562Drug
oral dosing of 10 mg PF-06412562 tablets three times a day for 14 days
25 mg PF-06412562Drug
oral dosing of 25 mg PF-06412562 tablets three times a day for 14 days
PF-06412562 TBD mgDrug
oral dosing of PF-06412562 tablets three times a day for 14 days. Dosage and frequency to-be-determined based on previous cohorts
PF-06412562 TBD mgDrug
oral dosing of PF-06412562 tablets three times a day for 14 days. Dosage and frequency to-be-determined based on previous cohorts
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Not described Receives: Drug: 3 mg PF-06412562 |
| Cohort 2 | Experimental | Not described Receives: Drug: 10 mg PF-06412562 |
| Cohort 3 | Experimental | Not described Receives: Drug: 25 mg PF-06412562 |
| Optional Cohort 4 | Experimental | Not described Receives: Drug: PF-06412562 TBD mg |
| Optional Cohort 5 | Experimental | Not described Receives: Drug: PF-06412562 TBD mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and toleration assessed by: adverse events, supine and standing vital sign measurements, electrocardiogram (ECG) standard 12 lead, blood and urine safety laboratory tests ,CogState and C-SSRS.
Measured: 0-15 days
Pharmacokinetics: Cmax, Tmax, AUCτ Ctrough, PTR, Rac on Cmax and AUCτ t1/2, CL/F, PTR,
Measured: 0-15 days
CogState at followup
Measured: 22-25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionMar 2014
- Study completionMar 2014
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 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
- NCT01959594
- Sponsor's protocol ID
- B7441002
- Status last verified
- Mar 2014
- First submitted
- 8 Oct 2013
- Last updated
- 28 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Double Blind, Sponsor Open, Randomized, Placebo Controlled, Dose Escalation, Parallel Group Study To Investigate The Safety, Tolerability And Pharmacokinetics Of Repeat Doses Of PF-06412562 In Healthy Subjects
- ClinicalTrials.gov ID
- NCT01959594
- Acronym / sponsor ID
- B7441002
- Conditions
- Healthy
- Keywords
- multiple doses, pharmacokinetics, safety, tolerability, healthy volunteers, steady state, cognitive impairment associated with schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 10 Oct 2013 (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 is designed to evaluate the safety and plasma concentrations of PF-06412562 in healthy volunteers following three times daily oral dosing of PF-06412562 for 14 days
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: 3 mg PF-06412562 |
| Cohort 2 | Experimental | Drug: 10 mg PF-06412562 |
| Cohort 3 | Experimental | Drug: 25 mg PF-06412562 |
| Optional Cohort 4 | Experimental | Drug: PF-06412562 TBD mg |
| Optional Cohort 5 | Experimental | Drug: PF-06412562 TBD mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy female subjects of non-childbearing potential and/or male subjects between the ages of 18 and 55 years, inclusive (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).
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs);
Key exclusion criteria (2 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
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 |
|---|---|---|
| 3 mg PF-06412562oral dosing of 3 mg PF-06412562 tablets three times a day for 14 days | Drug | Cohort 1 |
| 10 mg PF-06412562oral dosing of 10 mg PF-06412562 tablets three times a day for 14 days | Drug | Cohort 2 |
| 25 mg PF-06412562oral dosing of 25 mg PF-06412562 tablets three times a day for 14 days | Drug | Cohort 3 |
| PF-06412562 TBD mgoral dosing of PF-06412562 tablets three times a day for 14 days. Dosage and frequency to-be-determined based on previous cohorts | Drug | Optional Cohort 4 |
| PF-06412562 TBD mgoral dosing of PF-06412562 tablets three times a day for 14 days. Dosage and frequency to-be-determined based on previous cohorts | Drug | Optional Cohort 5 |
Primary outcome
Safety and toleration assessed by: adverse events, supine and standing vital sign measurements, electrocardiogram (ECG) standard 12 lead, blood and urine safety laboratory tests ,CogState and C-SSRS.
Time frame: 0-15 days
Pharmacokinetics: Cmax, Tmax, AUCτ Ctrough, PTR, Rac on Cmax and AUCτ t1/2, CL/F, PTR,
Time frame: 0-15 days
CogState at followup
Time frame: 22-25 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 28 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
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 3 mg PF-06412562, 10 mg PF-06412562 and 25 mg PF-06412562 in people with Healthy, 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 2 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: finished, as of the sponsor's last update on 28 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 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?
Safety and toleration assessed by: adverse events, supine and standing vital sign measurements, electrocardiogram (ECG) standard 12 lead, blood and urine safety laboratory tests ,CogState and C-SSRS. (time frame: 0-15 days). The study lists 3 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 28 Mar 2014; AzTrials last refreshed its copy on 7 Nov 2026.