HealthyPhase 1NCT02066909

A Study To Observe Safety And Blood Concentrations Of PF-06649751 During And Following The Oral Administration Of Multiple Doses Of PF-06649751 In Healthy Adult Western and Japanese Volunteers

A Phase 1 study testing 0.15 mg PF-06649751, 0.5 mg PF-06649751 and 1.5 mg PF-06649751 in people with Healthy, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: 0.15 mg PF-06649751, 0.5 mg PF-06649751 and 1.5 mg PF-06649751
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 77 participants
Where: 1 siteUnited States
Study dates: Feb 2014to Apr 2015
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 males and/or female subjects of non childbearing potential 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).
Cohort 9 only: Japanese subjects must have four biologic Japanese grandparents who were born in Japan.

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 the 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

New Haven Clinical Research Unit
New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: A 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-06649751 In Healthy Western And Japanese Subjects

This study is designed to evaluate the safety and plasma concentrations of PF-06649751 in healthy volunteers following one or two times daily oral dosing of PF-06649751 for 14 days (Cohorts 1 - 4), 21 days (Cohort 5), or 28 days (Cohorts 6 - 8). Cohort 9 will dose Japanese healthy volunteers in a manner identical to Cohort 4 and is intended to bridge the safety/tolerability and PK data from the Western and Japanese populations.

Conditions: Healthy
Being tested: 0.15 mg PF-06649751, 0.5 mg PF-06649751, 1.5 mg PF-06649751, 1.5 mg PF-06649751 21 Days, 3.0 mg PF-06649751
Keywords: pharmacokinetics, safety, tolerability, healthy volunteers, steady state, multiple doses, Japanese subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

0.15 mg PF-06649751Drug
Oral dosing of 0.15 mg PF-06649751 extemporaneously-prepared solution given once-daily for 14 days.
0.5 mg PF-06649751Drug
Oral dosing of 0.5 mg PF-06649751 extemporaneously-prepared solution given once-daily for 14 days.
0.5 mg PF-06649751Drug
Oral dosing of tablets up to 0.5 mg PF-06649751 given once-daily for 14 days.
1.5 mg PF-06649751Drug
Oral dosing of tablets up to 1.5 mg PF-06649751 given once-daily for 14 days.
1.5 mg PF-06649751 21 DaysDrug
Oral dosing of tablets up to 1.5 mg PF-06649751 given once-daily for 21 days.
3.0 mg PF-06649751Drug
Oral dosing of tablets up to 3.0 mg PF-06649751 given once-daily for 28 days.
5.0 mg PF-06649751Drug
Oral dosing of tablets up to 5.0 mg PF-06649751 given once-daily for 28 days.
8.0 mg PF-06649751Drug
Oral dosing of tablets up to 8.0 mg PF-06649751 given once-daily for 28 days.
1.5 mg PF-06649751 in healthy Japanese subjectsDrug
Oral dosing of tablets up to 1.5 mg PF-06649751 given once-daily for 14 days given in healthy Japanese subjects.

Study groups in NCT02066909
Study group	Role	What they receive
Cohort 1	Experimental	Dosing in healthy Western subjects. Receives: Drug: 0.15 mg PF-06649751
Cohort 2	Experimental	Dosing in healthy Western subjects. Receives: Drug: 0.5 mg PF-06649751
Cohort 3	Experimental	Dosing in healthy Western subjects. Receives: Drug: 0.5 mg PF-06649751
Cohort 4	Experimental	Dosing in healthy Western subjects. Receives: Drug: 1.5 mg PF-06649751
Cohort 5	Experimental	Dosing in healthy Western subjects. Receives: Drug: 1.5 mg PF-06649751 21 Days
Cohort 6	Experimental	Dosing in healthy Western subjects. Receives: Drug: 3.0 mg PF-06649751
Cohort 7	Experimental	Dosing in healthy Western subjects. Receives: Drug: 5.0 mg PF-06649751
Optional Cohort 8	Experimental	Dosing in healthy Western subjects. Cohort may not be conducted. Receives: Drug: 8.0 mg PF-06649751
Cohort 9	Experimental	Dosing in healthy Japanese subjects. Receives: Drug: 1.5 mg PF-06649751 in healthy Japanese subjects

What is being measured

The primary outcome is the main question the study is designed to answer.

Supine and standing vital sign measurements
Measurement of blood pressure and pulse rate
Measured: Days 1 - 18 (Cohorts 1 - 4, 9), Days 1 - 25 (Cohort 5), Days 1 - 32 (Cohorts 6 - 8) and follow-up
Amount of unchanged drug excreted in urine relative to dose (Ae%)
Measured: Day 14 (Cohorts 1 - 4, 9), Day 21 (Cohort 5), Day 28 (Cohorts 6 - 8)
Renal Clearance (CLR)
Measured: Day 14 (Cohort 1 - 4, 9), Day 21 (Cohort 5) and Day 28 (Cohorts 6 - 8)
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
Measured: Day 1, Day 14 (Cohorts 1 - 4, 9), Day 1 and Day 21 (Cohort 5), Day 1 and Day 28 (Cohorts 6 - 8)
Maximum Observed Plasma Concentration (Cmax)
Maximum plasma concentration
Measured: Day 1, Day 7, Day 14 (Cohorts 1 - 4, 9), Day 1 and 21 (Cohort 5), Day 1 and 28 (Cohorts 6 - 8)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time for Cmax
Measured: Day 1, Day 7, Day 14 (Cohorts 1 - 4, 9), Day 1 and 21 (Cohort 5), Day 1 and 28 (Cohorts 6 - 8)
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: Days 14 - 18 (Cohorts 1 - 4, 9), Days 21 - 25 (Cohort 5), Days 28 - 32 (Cohorts 6 - 8)
Apparent Oral Clearance (CL/F)
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Measured: Days 14 - 18 (Cohorts 1 - 4, 9), Days 21 - 25 (Cohort 5), Days 28 - 32 (Cohorts 6 - 8)
Apparent Volume of Distribution (Vz/F)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Measured: Days 14 - 18 (Cohorts 1 - 4, 9), Days 21 - 25 (Cohort 5), Days 28 - 32 (Cohorts 6 - 8)
Trough Concentration (Ctrough)
Minimum concentration pre-dose
Measured: Day 1 to 14 (Cohorts 1 - 4, 9), Day 1 to 21 (Cohort 5), Day 1 to 28 (Cohorts 6 - 8)
Ratio of accumulation for AUCtau (Rac AUCtau)
Ratio of accumulation for AUCtau. Corrected for titrated doses.
Measured: Day 1 and 14 (Cohorts 1 - 4, 9), Day 1 and 21 (Cohort 5), Day 1 and 28 (Cohorts 6 - 8)
Ratio of accumulation for Cmax (Rac Cmax)
Ratio of accumulation for Cmax. Corrected for titrated doses.
Measured: Day 1, Day 7 and Day 14 (Cohorts 1 - 4, 9), Day 1 and 21 (Cohort 5), Day 1 and 28 (Cohorts 6 - 8)
Peak-to-trough ratio (PTR)
Peak-to-trough ratio at steady state
Measured: Day 7 and Day 14 (Cohorts 1 - 4, 9), Day 21 (Cohort 5), Day 28 (Cohorts 6 - 8)
Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has subject engaged in non-suicidal self-injurious behavior").
Measured: Day 0 and 14 (Cohorts 1 - 4, 9), Day 0 and 21 (Cohort 5), Day 0 and 28 (Cohort 6 - 8) and follow-up
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Measured: Days 1 - 18 (Cohorts 1 - 4, 9), Days 1 - 25 (Cohort 5), Days 1 - 32 (Cohorts 6 - 8) and follow-up
Electrocardiogram (ECG)
Measurement of standard 12-lead ECG, single or triplicate
Measured: Days 1 - 18 (Cohorts 1 - 4, 9), Days 1 - 25 (Cohort 5), Days 1 - 32 (Cohorts 6 - 8) and follow-up
Number of Participants With Laboratory Test Values of Potential Clinical Importance
Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance.
Measured: Days 1 - 18 (Cohorts 1 - 4, 9), Days 1 - 25 (Cohort 5), Days 1 - 32 (Cohorts 6 - 8) and follow-up
Changes from baseline in total cholesterol, High Density Lipoprotein (HDL) cholesterol, Low Density Lipoprotein (LDL) cholesterol, triglycerides
Measured: Day 1 and Day 14 (Cohorts 1 - 4, 9), Day 1 and 21 (Cohort 5), Day 1 and 28 (Cohorts 6 - 8)
Amount of unchanged drug excreted in urine relative to dose (Ae)
Calculated from urinary volumes and concentration
Measured: Day 14 (Cohorts 1 - 4, 9), Day 21 (Cohort 5), Day 28 (Cohorts 6 - 8)

Secondary outcomes (1)

Metabolite Scouting
Identification of metabolites from blood and urine samples.
Measured: Day 1 (Cohorts 1 - 9) , Day 14 (Cohorts 1 - 4, 9), Day 21 (Cohort 5), Day 28 (Cohorts 6 - 8)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2014Apr 2015

First posted20 Feb 2014 (estimated)
Study startFeb 2014
Primary completionApr 2015
Study completionApr 2015

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: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02066909
Sponsor's protocol ID: B7601002
Other IDs: 2014-003776-23, 2014
Status last verified: Jun 2015
First submitted: 7 Feb 2014
Last updated: 24 Jun 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 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-06649751 In Healthy Western And Japanese Subjects
ClinicalTrials.gov ID: NCT02066909
Acronym / sponsor ID: B7601002
Conditions: Healthy
Keywords: pharmacokinetics, safety, tolerability, healthy volunteers, steady state, multiple doses, Japanese subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 77 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Feb 2014
Primary completion: Apr 2015 (actual)
Study completion: Apr 2015 (actual)
First posted: 20 Feb 2014 (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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 9

Arm	Type	Receives
Cohort 1	Experimental	Drug: 0.15 mg PF-06649751Dosing in healthy Western subjects.
Cohort 2	Experimental	Drug: 0.5 mg PF-06649751Dosing in healthy Western subjects.
Cohort 3	Experimental	Drug: 0.5 mg PF-06649751Dosing in healthy Western subjects.
Cohort 4	Experimental	Drug: 1.5 mg PF-06649751Dosing in healthy Western subjects.
Cohort 5	Experimental	Drug: 1.5 mg PF-06649751 21 DaysDosing in healthy Western subjects.
Cohort 6	Experimental	Drug: 3.0 mg PF-06649751Dosing in healthy Western subjects.
Cohort 7	Experimental	Drug: 5.0 mg PF-06649751Dosing in healthy Western subjects.
Optional Cohort 8	Experimental	Drug: 8.0 mg PF-06649751Dosing in healthy Western subjects. Cohort may not be conducted.
Cohort 9	Experimental	Drug: 1.5 mg PF-06649751 in healthy Japanese subjectsDosing in healthy Japanese subjects.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy males and/or female subjects of non childbearing potential 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).
Cohort 9 only: Japanese subjects must have four biologic Japanese grandparents who were born in Japan.

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 the 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
0.15 mg PF-06649751Oral dosing of 0.15 mg PF-06649751 extemporaneously-prepared solution given once-daily for 14 days.	Drug	Cohort 1
0.5 mg PF-06649751Oral dosing of 0.5 mg PF-06649751 extemporaneously-prepared solution given once-daily for 14 days.	Drug	Cohort 2
0.5 mg PF-06649751Oral dosing of tablets up to 0.5 mg PF-06649751 given once-daily for 14 days.	Drug	Cohort 3
1.5 mg PF-06649751Oral dosing of tablets up to 1.5 mg PF-06649751 given once-daily for 14 days.	Drug	Cohort 4
1.5 mg PF-06649751 21 DaysOral dosing of tablets up to 1.5 mg PF-06649751 given once-daily for 21 days.	Drug	Cohort 5
3.0 mg PF-06649751Oral dosing of tablets up to 3.0 mg PF-06649751 given once-daily for 28 days.	Drug	Cohort 6
5.0 mg PF-06649751Oral dosing of tablets up to 5.0 mg PF-06649751 given once-daily for 28 days.	Drug	Cohort 7
8.0 mg PF-06649751Oral dosing of tablets up to 8.0 mg PF-06649751 given once-daily for 28 days.	Drug	Optional Cohort 8
1.5 mg PF-06649751 in healthy Japanese subjectsOral dosing of tablets up to 1.5 mg PF-06649751 given once-daily for 14 days given in healthy Japanese subjects.	Drug	Cohort 9

Primary outcome

Supine and standing vital sign measurements
Time frame: Days 1 - 18 (Cohorts 1 - 4, 9), Days 1 - 25 (Cohort 5), Days 1 - 32 (Cohorts 6 - 8) and follow-up
Measurement of blood pressure and pulse rate
Amount of unchanged drug excreted in urine relative to dose (Ae%)
Time frame: Day 14 (Cohorts 1 - 4, 9), Day 21 (Cohort 5), Day 28 (Cohorts 6 - 8)
Renal Clearance (CLR)
Time frame: Day 14 (Cohort 1 - 4, 9), Day 21 (Cohort 5) and Day 28 (Cohorts 6 - 8)
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
Time frame: Day 1, Day 14 (Cohorts 1 - 4, 9), Day 1 and Day 21 (Cohort 5), Day 1 and Day 28 (Cohorts 6 - 8)
Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 1, Day 7, Day 14 (Cohorts 1 - 4, 9), Day 1 and 21 (Cohort 5), Day 1 and 28 (Cohorts 6 - 8)
Maximum plasma concentration
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Day 1, Day 7, Day 14 (Cohorts 1 - 4, 9), Day 1 and 21 (Cohort 5), Day 1 and 28 (Cohorts 6 - 8)
Time for Cmax
Plasma Decay Half-Life (t1/2)
Time frame: Days 14 - 18 (Cohorts 1 - 4, 9), Days 21 - 25 (Cohort 5), Days 28 - 32 (Cohorts 6 - 8)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Apparent Oral Clearance (CL/F)
Time frame: Days 14 - 18 (Cohorts 1 - 4, 9), Days 21 - 25 (Cohort 5), Days 28 - 32 (Cohorts 6 - 8)
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Apparent Volume of Distribution (Vz/F)
Time frame: Days 14 - 18 (Cohorts 1 - 4, 9), Days 21 - 25 (Cohort 5), Days 28 - 32 (Cohorts 6 - 8)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Trough Concentration (Ctrough)
Time frame: Day 1 to 14 (Cohorts 1 - 4, 9), Day 1 to 21 (Cohort 5), Day 1 to 28 (Cohorts 6 - 8)
Minimum concentration pre-dose
Ratio of accumulation for AUCtau (Rac AUCtau)
Time frame: Day 1 and 14 (Cohorts 1 - 4, 9), Day 1 and 21 (Cohort 5), Day 1 and 28 (Cohorts 6 - 8)
Ratio of accumulation for AUCtau. Corrected for titrated doses.
Ratio of accumulation for Cmax (Rac Cmax)
Time frame: Day 1, Day 7 and Day 14 (Cohorts 1 - 4, 9), Day 1 and 21 (Cohort 5), Day 1 and 28 (Cohorts 6 - 8)
Ratio of accumulation for Cmax. Corrected for titrated doses.
Peak-to-trough ratio (PTR)
Time frame: Day 7 and Day 14 (Cohorts 1 - 4, 9), Day 21 (Cohort 5), Day 28 (Cohorts 6 - 8)
Peak-to-trough ratio at steady state
Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Day 0 and 14 (Cohorts 1 - 4, 9), Day 0 and 21 (Cohort 5), Day 0 and 28 (Cohort 6 - 8) and follow-up
C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has subject engaged in non-suicidal self-injurious behavior").
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Days 1 - 18 (Cohorts 1 - 4, 9), Days 1 - 25 (Cohort 5), Days 1 - 32 (Cohorts 6 - 8) and follow-up
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Electrocardiogram (ECG)
Time frame: Days 1 - 18 (Cohorts 1 - 4, 9), Days 1 - 25 (Cohort 5), Days 1 - 32 (Cohorts 6 - 8) and follow-up
Measurement of standard 12-lead ECG, single or triplicate
Number of Participants With Laboratory Test Values of Potential Clinical Importance
Time frame: Days 1 - 18 (Cohorts 1 - 4, 9), Days 1 - 25 (Cohort 5), Days 1 - 32 (Cohorts 6 - 8) and follow-up
Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance.
Changes from baseline in total cholesterol, High Density Lipoprotein (HDL) cholesterol, Low Density Lipoprotein (LDL) cholesterol, triglycerides
Time frame: Day 1 and Day 14 (Cohorts 1 - 4, 9), Day 1 and 21 (Cohort 5), Day 1 and 28 (Cohorts 6 - 8)
Amount of unchanged drug excreted in urine relative to dose (Ae)
Time frame: Day 14 (Cohorts 1 - 4, 9), Day 21 (Cohort 5), Day 28 (Cohorts 6 - 8)
Calculated from urinary volumes and concentration

1 secondary outcome

Metabolite Scouting
Time frame: Day 1 (Cohorts 1 - 9) , Day 14 (Cohorts 1 - 4, 9), Day 21 (Cohort 5), Day 28 (Cohorts 6 - 8)

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 24 Jun 2015.
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 0.15 mg PF-06649751, 0.5 mg PF-06649751 and 1.5 mg PF-06649751 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 3 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 24 Jun 2015. 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?

Supine and standing vital sign measurements (time frame: Days 1 - 18 (Cohorts 1 - 4, 9), Days 1 - 25 (Cohort 5), Days 1 - 32 (Cohorts 6 - 8) and follow-up). The study lists 19 primary outcomes in all. 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 NCT02066909.

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 24 Jun 2015.