HealthyPhase 1NCT02208284
A Single Oral Dose Study Of PF-06427878 In Healthy Adult Subjects
A Phase 1 study testing PF-06427878 in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single oral doses of PF-06427878 in healthy adult subjects. 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?
- PF-06427878
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Dec 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 male and/or female subjects of non childbearing potential.
- Body Mass Index (BMI) of 17.5 to 35.4 kg/m2; and a total body weight >50 kg
- Subjects with fasting TG level of >=90 mg/dL and <=500 mg/dL following an overnight fast
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).
Trial locations and contacts
1 site in 1 country.
United States1 site
New Haven Clinical Research Unit
New Haven, Connecticut, 06511
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06427878 Co-administered With Meal In Healthy Adult Subjects
PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single oral doses of PF-06427878 in healthy adult subjects.
- Conditions
- Healthy
- Being tested
- PF-06427878, Placebo
- Keywords
- Single Ascending Dose, healthy subjects, Hyperlipidemia, Lipid Metabolism Disorders, Metabolic Diseases
- Medical subject headings
- Hyperlipidemias, Lipid Metabolism Disorders, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06427878Drug
PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
PlaceboDrug
PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
PF-06427878Drug
PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
PlaceboDrug
PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
PF-06427878Drug
PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
PlaceboDrug
PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1-PF-06427878 or placebo | Experimental | Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK. Receives: Drug: PF-06427878; Drug: Placebo |
| Cohort 2-PF-06427878 or placebo | Experimental | Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK. Receives: Drug: PF-06427878; Drug: Placebo |
| Cohort 3-PF-06427878 or placebo | Experimental | Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK. Receives: Drug: PF-06427878; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of adverse events (AEs).
Measured: 0-48 h post dose
Assessment of clinical laboratory tests.
Measured: 0-48 h post dose
Assessment of vital signs (including blood pressure and pulse rate).
Measured: 0-48 h post dose
Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG).
Measured: 0-48 h post dose
Secondary outcomes (7)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06427878
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] for PF-06427878
AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06427878
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
Apparent Oral Clearance (CL/F) for PF-06427878
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. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
Apparent Volume of Distribution (Vz/F) for PF-06427878
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: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
Plasma Decay Half-Life (t1/2) for PF-06427878
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2014
- Study completionDec 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 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
- NCT02208284
- Sponsor's protocol ID
- B7871001
- Status last verified
- Mar 2015
- First submitted
- 30 Jul 2014
- Last updated
- 4 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06427878 Co-administered With Meal In Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02208284
- Acronym / sponsor ID
- B7871001
- Conditions
- Healthy
- Keywords
- Single Ascending Dose, healthy subjects, Hyperlipidemia, Lipid Metabolism Disorders, Metabolic Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 5 Aug 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.
PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single oral doses of PF-06427878 in healthy adult subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1-PF-06427878 or placebo | Experimental | Drug: PF-06427878, Drug: PlaceboSingle ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK. |
| Cohort 2-PF-06427878 or placebo | Experimental | Drug: PF-06427878, Drug: PlaceboSingle ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK. |
| Cohort 3-PF-06427878 or placebo | Experimental | Drug: PF-06427878, Drug: PlaceboSingle ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and/or female subjects of non childbearing potential.
- Body Mass Index (BMI) of 17.5 to 35.4 kg/m2; and a total body weight >50 kg
- Subjects with fasting TG level of >=90 mg/dL and <=500 mg/dL following an overnight fast
Key exclusion criteria (1 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).
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-06427878PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension. | Drug | Cohort 1-PF-06427878 or placebo |
| PlaceboPF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension. | Drug | Cohort 1-PF-06427878 or placebo |
| PF-06427878PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension. | Drug | Cohort 2-PF-06427878 or placebo |
| PlaceboPF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension. | Drug | Cohort 2-PF-06427878 or placebo |
| PF-06427878PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension. | Drug | Cohort 3-PF-06427878 or placebo |
| PlaceboPF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension. | Drug | Cohort 3-PF-06427878 or placebo |
Primary outcome
Assessment of adverse events (AEs).
Time frame: 0-48 h post dose
Assessment of clinical laboratory tests.
Time frame: 0-48 h post dose
Assessment of vital signs (including blood pressure and pulse rate).
Time frame: 0-48 h post dose
Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG).
Time frame: 0-48 h post dose
7 secondary outcomes
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06427878
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] for PF-06427878
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06427878
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
Apparent Oral Clearance (CL/F) for PF-06427878
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
Apparent Volume of Distribution (Vz/F) for PF-06427878
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
Plasma Decay Half-Life (t1/2) for PF-06427878
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
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 Mar 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 PF-06427878 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 1 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 Mar 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?
Assessment of adverse events (AEs). (time frame: 0-48 h post dose). The study lists 4 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 4 Mar 2015.