A Study To Assess The Safety Of PF-05335810 In Hypercholesterolemic Subjects

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01720537
• Other study ID #: B3091001
• Status: Completed
• Phase: Phase 1
• Start date: July 2012
• Est. completion date: October 2013

Study information

• Verified date: November 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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%).

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Biological:
• PF-05335810 Dose A
Single SC Injection
• PF-05335810 Dose B
Single Subcutaneous Injection(s)
• Placebo
Single Subcutaneous Injection(s)
• PF-05335810 Dose B
Single Intravenous Infusion
• Placebo
Single Intravenous Infusion
• PF-04950615 Dose A
Single Subcutaneous Injection(s)
• PF-04950615 Dose A
Single Intravenous Infusion
• PF-05335810 Dose C
Single Subcutaneous Injection(s)
• Placebo
Single Subcutaneous Injection(s)
• PF-05335810 Dose C
Single Intravenous Infusion
• Placebo
Single Intravenous Infusion
• PF-04950615
Single Subcutaneous Injection(s)
• PF-05335810 Dose D
Single Subcutaneous Injection(s)
• Placebo
Single Subcutaneous Injection(s)
• PF-05335810 Dose E
Multiple fixed dosages administered in subcutaneous injections, monthly for 3 months.
• PF-05335810 Dose D
Single Intravenous Infusion
• Placebo
Single Intravenous Infusion

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Kalamazoo	Michigan
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	New Haven	Connecticut
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline up to Day 85/169 or Early Termination (ET)
Primary	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.	Baseline up to Day 85/169 or Early Termination (ET)
Primary	Change From Baseline in Heart Rate		Baseline, Day 1 to 85/169 or ET
Primary	Diastolic Blood Pressure		Baseline, Day 1 to 85/169 or ET
Primary	Change From Baseline in Electrocardiogram (ECG) Parameters		Baseline, Day 1 to 85/169 or ET
Primary	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.	Baseline, Day 1 to 85/169 or ET
Secondary	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).	Day1 pre-dose to Day 85/169 or ET
Secondary	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)	Day1 pre-dose to Day 85/169 or ET
Secondary	Maximum Observed Plasma Concentration (Cmax)		Day1 pre-dose to Day 85/169 or ET
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		Day1 pre-dose to Day 85/169 or ET
Secondary	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.	Day1 pre-dose to Day 85/169 or ET
Secondary	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.	Day1 pre-dose to Day 85/169 or ET
Secondary	Plasma Decay Half-Life (t1/2)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	Day1 pre-dose to Day 85/169 or ET
Secondary	Absolute Bioavailability (%F)		Day1 pre-dose to Day 85/169 or ET

External Links

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