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

Phase 1

Completed

• Conditions: Hypercholesterolemia
• Interventions: Biological: PF-05335810 Dose A; Biological: PF-05335810 Dose B; Biological: PF-05335810 Dose E; Biological: PF-05335810 Dose C; Biological: PF-05335810 Dose D; Biological: Placebo; Biological: PF-04950615; Biological: PF-04950615 Dose A

• Registration Number: NCT01720537
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-03
• Study First Submitted QC: 2012-10-31
• Study First Posted: 2012-11-02
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-30
• Last Update Posted: 2018-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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%).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 3	PF-04950615	-
Cohort 1	PF-05335810 Dose A	-
Cohort 2	PF-05335810 Dose B	-
Cohort 4	Placebo	-
Cohort 5	PF-05335810 Dose E	-
Cohort 6	Placebo	-
Cohort 3	PF-05335810 Dose C	-
Cohort 3	Placebo	-
Cohort 4	PF-05335810 Dose D	-
Cohort 6	PF-05335810 Dose D	-
Cohort 2	Placebo	-
Cohort 2	PF-04950615 Dose A	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	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.
Change From Baseline in Heart Rate	Baseline, Day 1 to 85/169 or ET
Diastolic Blood Pressure	Baseline, Day 1 to 85/169 or ET
Change From Baseline in Electrocardiogram (ECG) Parameters	Baseline, Day 1 to 85/169 or ET
Number of Participants With Laboratory Test Values of Potential Clinical Importance	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.

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]	Day1 pre-dose to Day 85/169 or ET	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)]	Day1 pre-dose to Day 85/169 or ET	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)	Day1 pre-dose to Day 85/169 or ET
Apparent Oral Clearance (CL/F)	Day1 pre-dose to Day 85/169 or ET	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.
Absolute Bioavailability (%F)	Day1 pre-dose to Day 85/169 or ET
Time to Reach Maximum Observed Plasma Concentration (Tmax)	Day1 pre-dose to Day 85/169 or ET
Plasma Decay Half-Life (t1/2)	Day1 pre-dose to Day 85/169 or ET	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Apparent Volume of Distribution (Vz/F)	Day1 pre-dose to Day 85/169 or ET	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 San Antonio, Texas, United States