Pharmacokinetics And Relative Bioavailability Of PF-04950615 When Administered To The Abdomen, Thigh Or Upper Arm

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02043301
First received: January 21, 2014
Last updated: September 9, 2014
Last verified: September 2014
  Purpose

This study aims to characterize the single dose pharmacokinetics of PF-04950616 following subcutaneous injection to the abdomen, upper arm or the thigh.


Condition Intervention Phase
Hypercholesterolemia
Device: PF-04950615
Biological: PF-04950615
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Phase 1, Open-Label, Randomized, Single Dose, Parallel Group Study To Assess Injection Site Relative Bioavailability Of PF-04950615 Following Subcutaneous Administration In Adult Subjects With Hypercholesterolemia

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] [ Time Frame: 85 days ] [ Designated as safety issue: No ]
    Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).

  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 85 days ] [ Designated as safety issue: No ]
    Maximum observed plasma concentration


Secondary Outcome Measures:
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 85 days ] [ Designated as safety issue: No ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  • Apparent SC Clearance (CL/F) [ Time Frame: 85 days ] [ Designated as safety issue: No ]
    A measure of the rate at which a drug substance is removed from blood divided by bioavailability

  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 85 day ] [ Designated as safety issue: No ]
    The time to reach maximum observed plasma concentration

  • Apparent Volume of Distribution (Vz/F) [ Time Frame: 85 days ] [ Designated as safety issue: No ]
    A theoretical volume in which the total amount of drug is uniformly distributed to produce the desired plasma concentration divided by bioavailability

  • Plasma Terminal Elimination Half-Life (t1/2) [ Time Frame: 85 days ] [ Designated as safety issue: No ]
    The time measured for the terminal plasma concentration to decrease by one half

  • Area under the LDL-C effect curve [ Time Frame: 85 days ] [ Designated as safety issue: No ]
    Area under the LDL-C effect curve from time 0 to the last timepoint with measurable effect

  • Maximum LDL-C lowering [ Time Frame: 85 days ] [ Designated as safety issue: No ]
    Maximum LDL-C lowering

  • Time to reach maximum LDL-C lowering [ Time Frame: 85 days ] [ Designated as safety issue: No ]
    Time to reach the maximum LDL-C lowering


Estimated Enrollment: 75
Study Start Date: April 2014
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Single 150 mg PF-04950615 dose administered to the abdomen Device: PF-04950615
Single 150 mg PF-04950615 dose administered SC to the abdomen
Experimental: Single 150 mg PF-04950615 dose administered to the upper arm Biological: PF-04950615
Single 150 mg PF-04950615 dose administered SC to the upper arm
Experimental: Single 150 mg PF-04950615 dose administered to the thigh Biological: PF-04950615
Single 150 mg PF-04950615 dose administered SC to the thigh

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects 18 to 65 years of age.
  • Body Mass Index (BMI) ≤ 33 kg/m2, and total body weight of 60 kg to 90 kg (132 lbs to 198 lbs).
  • Fasting LDL-C must be > 130 mg/dL (borderline high per NCEP ATP III criteria) at two qualifying visits: initial screening (Days -28 to -14) and Day -7.

Exclusion Criteria:

  • Poorly controlled type 1 or type 2 diabetes mellitus (HbA1c > 9.0%).
  • History of a cardiovascular or cerebrovascular event (eg, MI, stroke, TIA) or related procedure (eg, angioplasty) during the past year.
  • Subjects who meet the New York Heart Association (NYHA) criteria for congestive heart failure (CHF) classes III or IV.
  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: NCT02043301

Locations
United States, California
Pfizer Investigational Site
Anaheim, California, United States, 92801
United States, Florida
Pfizer Investigational Site
South Miami, Florida, United States, 33143
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212
Pfizer Investigational Site
Overland Park, Kansas, United States, 66211
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02043301     History of Changes
Other Study ID Numbers: B1481024
Study First Received: January 21, 2014
Last Updated: September 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
pharmacokinetics
bioavailability
PF-04950615

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014