NCT01435382

Brief Summary

This Phase 1 study has been designed to evaluate the absolute bioavailability of PF-04950615 (RN316) in subjects with hypercholesterolemia who are not currently on lipid-lowering therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 16, 2011

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

July 23, 2018

Completed
Last Updated

July 23, 2018

Status Verified

October 1, 2017

Enrollment Period

4 months

First QC Date

September 7, 2011

Results QC Date

October 4, 2017

Last Update Submit

October 6, 2017

Conditions

HypercholesterolemiaDyslipidemiasHyperlipidemiasLipid Metabolism DisordersMetabolic Diseases

Keywords

PF-04950615RN316

Outcome Measures

Primary Outcomes (10)

  • Maximum Observed Plasma Concentration (Cmax) of PF-04950615

    Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose

  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615

    Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose

  • Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of PF-04950615

    Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose

  • Area Under the Plasma Concentration-Time Curve From Time Zero To Infinity (AUCinf) of PF-04950615

    Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose

  • Apparent Clearance (CL/F) of PF-04950615 Subcutaneous Groups

    Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance (CL/F) is influenced by the fraction of the dose absorbed from plasma after SC administration of drug.

    Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose

  • Clearance (CL) of PF-04950615 Intravenous Group

    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.

    Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose

  • Apparent Volume of Distribution (Vz/F) of PF-04950615 Subcutaneous Groups

    Volume of distribution (Vz) 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. Vz/F is influenced by the fraction of the dose absorbed from plasma after SC administration of drug.

    Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose

  • Volume of Distribution at Steady State (Vss) of PF-04950615 Intravenous Group

    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. Vss is determined when overall intake of drug is in dynamic equilibrium with its elimination.

    Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose

  • Terminal Elimination Half-life (t1/2) of PF-04950615

    t1/2 is the time measured for the plasma concentration of drug to decrease by one half.

    Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose

  • Absolute Bioavailability of PF-04950615 Subcutaneous Groups

    Bioavailability is defined as the rate and extent to which the active moiety administered drug reaches the systemic circulation. Absolute bioavailability of the subcutaneous doses was estimated by comparing log-transformed dose-normalized AUClast for subcutaneous to intravenous dose.

    Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose

Secondary Outcomes (3)

  • Absolute Value of Fasting Low-density Lipoprotein Cholesterol (LDL-C)

    Day 2, 3, 4, 5, 6, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85

  • Percent Change From Baseline in Fasting Low-density Lipoprotein Cholesterol (LDL-C) at Day 2, 3, 4, 5, 6, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71 and 85

    Baseline, Day 2, 3, 4, 5, 6, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85

  • Duration of Fasting LDL-C Suppressed Below 70 mg/dL and 100 mg/dL

    Day 1 up to Day 85

Other Outcomes (10)

  • Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Day 1 up to Day 85

  • Number of Adverse Events (AEs) by Severity

    Day 1 up to Day 85

  • Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Day 1 up to Day 85

  • +7 more other outcomes

Study Arms (4)

Group A

EXPERIMENTAL
Biological: PF-04950615 (RN316)

Group B

EXPERIMENTAL
Biological: PF-04950615 (RN316)

Group C

EXPERIMENTAL
Biological: PF-04950615 (RN316)

Group D

EXPERIMENTAL
Biological: PF-04950615 (RN316)

Interventions

PF-04950615 (RN316)BIOLOGICAL

Dose A - single-dose intravenous infusion

Group A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fasting LDL-C greater than or equal to 130 mg/dL at two qualifying screening visits.
  • Total body weight greater than or equal to 50 kg (110 lbs) and less than or equal to 150 kg (330 lbs)

You may not qualify if:

  • Lipid-lowering prescription medications, homeopaths, herbal medicines, or nutritional supplements.
  • Poorly controlled type 1 or type 2 diabetes.
  • History of a cardiovascular or cerebrovascular event or related procedure during the past year.
  • Poorly controlled hypertension.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Profil Institute for Clinical Research, Inc.

Chula Vista, California, 91911, United States

Location

Elite Research Institute

Miami, Florida, 33169, United States

Location

Vince and Associates Clinical Research

Overland Park, Kansas, 66212, United States

Location

PAREXEL International - Baltimore Early Phase Clinical Unit

Baltimore, Maryland, 21225, United States

Location

Jasper Clinic, Inc.

Kalamazoo, Michigan, 49007, United States

Location

Prism Research

Saint Paul, Minnesota, 55114, United States

Location

Medpace Clinical Pharmacology Unit

Cincinnati, Ohio, 45212, United States

Location

Related Publications (2)

  • Wang EQ, Kaila N, Plowchalk D, Gibiansky L, Yunis C, Sweeney K. Population PK/PD modeling of low-density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti-PCSK9 monoclonal antibody. CPT Pharmacometrics Syst Pharmacol. 2023 Dec;12(12):2013-2026. doi: 10.1002/psp4.13050. Epub 2023 Nov 22.

    PMID: 37994400DERIVED

  • Udata C, Garzone PD, Gumbiner B, Joh T, Liang H, Liao KH, Williams JH, Meng X. A Mechanism-Based Pharmacokinetic/Pharmacodynamic Model for Bococizumab, a Humanized Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9, and Its Application in Early Clinical Development. J Clin Pharmacol. 2017 Jul;57(7):855-864. doi: 10.1002/jcph.867. Epub 2017 Feb 9.

    PMID: 28181260DERIVED

Related Links

MeSH Terms

Conditions

HypercholesterolemiaDyslipidemiasHyperlipidemiasLipid Metabolism DisordersMetabolic Diseases

Interventions

bococizumab

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2011

First Posted

September 16, 2011

Study Start

October 1, 2011

Primary Completion

February 1, 2012

Study Completion

April 1, 2012

Last Updated

July 23, 2018

Results First Posted

July 23, 2018

Record last verified: 2017-10

Locations

US(7)