A Study To Assess The Safety Of PF-05335810 In Hypercholesterolemic Subjects
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01720537
First received: August 3, 2012
Last updated: November 19, 2013
Last verified: November 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia |
Biological: PF-05335810 Dose A Biological: PF-05335810 Dose B Biological: Placebo Biological: PF-04950615 Dose A Biological: PF-05335810 Dose C Biological: PF-04950615 Biological: PF-05335810 Dose D Biological: PF-05335810 Dose E |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Day 85/169 or Early Termination (ET) ] [ Designated as safety issue: Yes ]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) ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]
- Diastolic Blood Pressure [ Time Frame: Baseline, Day 1 to 85/169 or ET ] [ Designated as safety issue: Yes ]
- Change From Baseline in Electrocardiogram (ECG) Parameters [ Time Frame: Baseline, Day 1 to 85/169 or ET ] [ Designated as safety issue: Yes ]
- Number of Participants With Laboratory Test Values of Potential Clinical Importance [ Time Frame: Baseline, Day 1 to 85/169 or ET ] [ Designated as safety issue: Yes ]Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance.
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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).
- 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 ] [ Designated as safety issue: No ]AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
- Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Day1 pre-dose to Day 85/169 or ET ] [ Designated as safety issue: No ]
- Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Day1 pre-dose to Day 85/169 or ET ] [ Designated as safety issue: No ]
- Apparent Volume of Distribution (Vz/F) [ Time Frame: Day1 pre-dose to Day 85/169 or ET ] [ Designated as safety issue: No ]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.
- Apparent Oral Clearance (CL/F) [ Time Frame: Day1 pre-dose to Day 85/169 or ET ] [ Designated as safety issue: No ]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.
- Plasma Decay Half-Life (t1/2) [ Time Frame: Day1 pre-dose to Day 85/169 or ET ] [ Designated as safety issue: No ]Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
- Absolute Bioavailability (%F) [ Time Frame: Day1 pre-dose to Day 85/169 or ET ] [ Designated as safety issue: No ]
| Enrollment: | 136 |
| Study Start Date: | July 2012 |
| Study Completion Date: | October 2013 |
| Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Cohort 1 |
Biological: PF-05335810 Dose A
Single SC Injection
|
| Experimental: Cohort 2 |
Biological: PF-05335810 Dose B
Single Subcutaneous Injection(s)
Biological: Placebo
Single Subcutaneous Injection(s)
Biological: PF-05335810 Dose B
Single Intravenous Infusion
Biological: Placebo
Single Intravenous Infusion
Biological: PF-04950615 Dose A
Single Subcutaneous Injection(s)
Biological: PF-04950615 Dose A
Single Intravenous Infusion
|
| Experimental: Cohort 3 |
Biological: PF-05335810 Dose C
Single Subcutaneous Injection(s)
Biological: Placebo
Single Subcutaneous Injection(s)
Biological: PF-05335810 Dose C
Single Intravenous Infusion
Biological: Placebo
Single Intravenous Infusion
Biological: PF-04950615
Single Subcutaneous Injection(s)
|
| Experimental: Cohort 4 |
Biological: PF-05335810 Dose D
Single Subcutaneous Injection(s)
Biological: Placebo
Single Subcutaneous Injection(s)
|
| Experimental: Cohort 5 |
Biological: PF-05335810 Dose E
Multiple fixed dosages administered in subcutaneous injections, monthly for 3 months.
|
| Experimental: Cohort 6 |
Biological: PF-05335810 Dose D
Single Intravenous Infusion
Biological: Placebo
Single Intravenous Infusion
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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%).
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720537
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720537
Locations
| United States, Connecticut | |
| Pfizer Investigational Site | |
| New Haven, Connecticut, United States, 06511 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Miami, Florida, United States, 33169 | |
| Pfizer Investigational Site | |
| South Miami, Florida, United States, 33143 | |
| United States, Kansas | |
| Pfizer Investigational Site | |
| Overland Park, Kansas, United States, 66212 | |
| United States, Michigan | |
| Pfizer Investigational Site | |
| Kalamazoo, Michigan, United States, 49007 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Cincinnati, Ohio, United States, 45227 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78209 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01720537 History of Changes |
| Other Study ID Numbers: | B3091001 |
| Study First Received: | August 3, 2012 |
| Last Updated: | November 19, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
High Cholesterol Dyslipidemia |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on September 28, 2016