HypercholesterolemiaPhase 1NCT01720537
A Study To Assess The Safety Of PF-05335810 In Hypercholesterolemic Subjects
A Phase 1 study testing PF-05335810 Dose A, PF-05335810 Dose B and PF-04950615 Dose A in people with Hypercholesterolemia, run by Pfizer at 7 sites in United States.
Trial summary
This study is to evaluate the safety, tolerability and immunogenicity of single, ascending or multiple fixed subcutaneous and intravenous administrations of PF 05335810 to hypercholesterolemic subjects when added on to a daily statin dose. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- PF-05335810 Dose A, PF-05335810 Dose B and PF-04950615 Dose A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 7 sitesUnited States
- Study dates
- Jul 2012to Oct 2013
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- On stable daily doses of a statin for 45 days prior to receiving study treatment.
- Fasting LDL C equal or greater than 80 mg/dL at screening and visit approximately 1 week prior to randomization.
Who cannot join
- History of a cardiovascular or cerebrovascular event or procedure within one year of randomization.
- Poorly controlled type 1 or type 2 diabetes mellitus (defined as HbA1c >9%).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Pfizer Investigational Site
Cincinnati, Ohio, 45227
Pfizer Investigational Site
Kalamazoo, Michigan, 49007
Pfizer Investigational Site
Miami, Florida, 33169
Pfizer Investigational Site
New Haven, Connecticut, 06511
Pfizer Investigational Site
Overland Park, Kansas, 66212
Pfizer Investigational Site
San Antonio, Texas, 78209
Pfizer Investigational Site
South Miami, Florida, 33143
About this study
Official title: A Phase I, Placebo-Controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Single, Ascending Doses Of PF-05335810 In Hypercholesterolemic Subjects, With One, Open-Label, Multiple Fixed Dosage Cohort
This study is to evaluate the safety, tolerability and immunogenicity of single, ascending or multiple fixed subcutaneous and intravenous administrations of PF 05335810 to hypercholesterolemic subjects when added on to a daily statin dose.
- Conditions
- Hypercholesterolemia
- Being tested
- PF-05335810 Dose A, PF-05335810 Dose B, Placebo, PF-04950615 Dose A, PF-05335810 Dose C
- Keywords
- High Cholesterol, Dyslipidemia
- Medical subject headings
- Hypercholesterolemia, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-05335810 Dose ABiological
Single SC Injection
PF-05335810 Dose BBiological
Single Subcutaneous Injection(s)
PlaceboBiological
Single Subcutaneous Injection(s)
PF-05335810 Dose BBiological
Single Intravenous Infusion
PlaceboBiological
Single Intravenous Infusion
PF-04950615 Dose ABiological
Single Subcutaneous Injection(s)
PF-04950615 Dose ABiological
Single Intravenous Infusion
PF-05335810 Dose CBiological
Single Subcutaneous Injection(s)
PlaceboBiological
Single Subcutaneous Injection(s)
PF-05335810 Dose CBiological
Single Intravenous Infusion
PlaceboBiological
Single Intravenous Infusion
PF-04950615Biological
Single Subcutaneous Injection(s)
PF-05335810 Dose DBiological
Single Subcutaneous Injection(s)
PlaceboBiological
Single Subcutaneous Injection(s)
PF-05335810 Dose EBiological
Multiple fixed dosages administered in subcutaneous injections, monthly for 3 months.
PF-05335810 Dose DBiological
Single Intravenous Infusion
PlaceboBiological
Single Intravenous Infusion
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Not described Receives: Biological: PF-05335810 Dose A |
| Cohort 2 | Experimental | Not described Receives: Biological: PF-05335810 Dose B; Biological: Placebo; Biological: PF-04950615 Dose A |
| Cohort 3 | Experimental | Not described Receives: Biological: PF-05335810 Dose C; Biological: Placebo; Biological: PF-04950615 |
| Cohort 4 | Experimental | Not described Receives: Biological: PF-05335810 Dose D; Biological: Placebo |
| Cohort 5 | Experimental | Not described Receives: Biological: PF-05335810 Dose E |
| Cohort 6 | Experimental | Not described Receives: Biological: PF-05335810 Dose D; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Baseline up to Day 85/169 or Early Termination (ET)
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: Baseline up to Day 85/169 or Early Termination (ET)
Change From Baseline in Heart Rate
Measured: Baseline, Day 1 to 85/169 or ET
Diastolic Blood Pressure
Measured: Baseline, Day 1 to 85/169 or ET
Change From Baseline in Electrocardiogram (ECG) Parameters
Measured: Baseline, Day 1 to 85/169 or ET
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: Baseline, Day 1 to 85/169 or ET
Secondary outcomes (8)
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
Measured: Day1 pre-dose to Day 85/169 or ET
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Measured: Day1 pre-dose to Day 85/169 or ET
Maximum Observed Plasma Concentration (Cmax)
Measured: Day1 pre-dose to Day 85/169 or ET
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: Day1 pre-dose to Day 85/169 or ET
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: Day1 pre-dose to Day 85/169 or ET
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. 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: Day1 pre-dose to Day 85/169 or ET
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: Day1 pre-dose to Day 85/169 or ET
Absolute Bioavailability (%F)
Measured: Day1 pre-dose to Day 85/169 or ET
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startJul 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 133 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
- NCT01720537
- Sponsor's protocol ID
- B3091001
- Status last verified
- Nov 2018
- First submitted
- 3 Aug 2012
- 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
- A Phase I, Placebo-Controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Single, Ascending Doses Of PF-05335810 In Hypercholesterolemic Subjects, With One, Open-Label, Multiple Fixed Dosage Cohort
- ClinicalTrials.gov ID
- NCT01720537
- Acronym / sponsor ID
- B3091001
- Conditions
- Hypercholesterolemia
- Keywords
- High Cholesterol, Dyslipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 2 Nov 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 is to evaluate the safety, tolerability and immunogenicity of single, ascending or multiple fixed subcutaneous and intravenous administrations of PF 05335810 to hypercholesterolemic subjects when added on to a daily statin dose.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: PF-05335810 Dose A |
| Cohort 2 | Experimental | Biological: PF-05335810 Dose B, Biological: Placebo, Biological: PF-04950615 Dose A |
| Cohort 3 | Experimental | Biological: PF-05335810 Dose C, Biological: Placebo, Biological: PF-04950615 |
| Cohort 4 | Experimental | Biological: PF-05335810 Dose D, Biological: Placebo |
| Cohort 5 | Experimental | Biological: PF-05335810 Dose E |
| Cohort 6 | Experimental | Biological: PF-05335810 Dose D, Biological: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- On stable daily doses of a statin for 45 days prior to receiving study treatment.
- Fasting LDL C equal or greater than 80 mg/dL at screening and visit approximately 1 week prior to randomization.
Key exclusion criteria (2 listed)
- History of a cardiovascular or cerebrovascular event or procedure within one year of randomization.
- Poorly controlled type 1 or type 2 diabetes mellitus (defined as HbA1c >9%).
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-05335810 Dose ASingle SC Injection | Biological | Cohort 1 |
| PF-05335810 Dose BSingle Subcutaneous Injection(s) | Biological | Cohort 2 |
| PlaceboSingle Subcutaneous Injection(s) | Biological | Cohort 2 |
| PF-05335810 Dose BSingle Intravenous Infusion | Biological | Cohort 2 |
| PlaceboSingle Intravenous Infusion | Biological | Cohort 2 |
| PF-04950615 Dose ASingle Subcutaneous Injection(s) | Biological | Cohort 2 |
| PF-04950615 Dose ASingle Intravenous Infusion | Biological | Cohort 2 |
| PF-05335810 Dose CSingle Subcutaneous Injection(s) | Biological | Cohort 3 |
| PlaceboSingle Subcutaneous Injection(s) | Biological | Cohort 3 |
| PF-05335810 Dose CSingle Intravenous Infusion | Biological | Cohort 3 |
| PlaceboSingle Intravenous Infusion | Biological | Cohort 3 |
| PF-04950615Single Subcutaneous Injection(s) | Biological | Cohort 3 |
| PF-05335810 Dose DSingle Subcutaneous Injection(s) | Biological | Cohort 4 |
| PlaceboSingle Subcutaneous Injection(s) | Biological | Cohort 4 |
| PF-05335810 Dose EMultiple fixed dosages administered in subcutaneous injections, monthly for 3 months. | Biological | Cohort 5 |
| PF-05335810 Dose DSingle Intravenous Infusion | Biological | Cohort 6 |
| PlaceboSingle Intravenous Infusion | Biological | Cohort 6 |
Primary outcome
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to Day 85/169 or Early Termination (ET)
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.
Number of Participants With Laboratory Test Values of Potential Clinical Importance
Time frame: Baseline up to Day 85/169 or Early Termination (ET)
Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance.
Change From Baseline in Heart Rate
Time frame: Baseline, Day 1 to 85/169 or ET
Diastolic Blood Pressure
Time frame: Baseline, Day 1 to 85/169 or ET
Change From Baseline in Electrocardiogram (ECG) Parameters
Time frame: Baseline, Day 1 to 85/169 or ET
Number of Participants With Laboratory Test Values of Potential Clinical Importance
Time frame: Baseline, Day 1 to 85/169 or ET
Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance.
8 secondary outcomes
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Time frame: Day1 pre-dose to Day 85/169 or ET
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
Time frame: Day1 pre-dose to Day 85/169 or ET
Maximum Observed Plasma Concentration (Cmax)
Time frame: Day1 pre-dose to Day 85/169 or ET
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Day1 pre-dose to Day 85/169 or ET
Apparent Volume of Distribution (Vz/F)
Time frame: Day1 pre-dose to Day 85/169 or ET
Apparent Oral Clearance (CL/F)
Time frame: Day1 pre-dose to Day 85/169 or ET
Plasma Decay Half-Life (t1/2)
Time frame: Day1 pre-dose to Day 85/169 or ET
Absolute Bioavailability (%F)
Time frame: Day1 pre-dose to Day 85/169 or ET
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
7 sites 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-05335810 Dose A, PF-05335810 Dose B and PF-04950615 Dose A in people with Hypercholesterolemia, run by Pfizer at 7 sites 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 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 7 sites 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?
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Baseline up to Day 85/169 or Early Termination (ET)). The study lists 6 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 Dec 2018.