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Completed

NCT Number: NCT02043301

Pharmacokinetics And Relative Bioavailability Of Bococizumab (PF-04950615; RN316) When Administered To The Abdomen, Thigh Or Upper Arm

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

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials, LLC, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bococizumab (PF-04950615; RN316)

Biological

Single 150 mg PF-04950615 dose administered SC to the abdomen

Primary outcomes

  1. Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinite Time (AUCinf)

    Time frame: Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.

    AUCinf is the area under the plasma concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time.

  2. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.

    Maximum observed concentration.

Secondary outcomes

  1. Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast)

    Time frame: Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.

    AUClast is area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration.

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.

    Time for maximum observed concentration.

  3. Apparent Clearance (CL/F)

    Time frame: Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.

    Apparent clearance following subcutaneous administration.

  4. Apparent Volume of Distribution (Vz/F)

    Time frame: Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.

    Apparent volume of distribution following subcutaneous administration.

  5. Terminal Elimination Half-Life (t1/2)

    Time frame: Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.

    Terminal elimination half-life following subcutaneous administration.

  6. Maximum Low-density Lipoprotein Cholesterol LDL-C Lowering Effect (Emax): Absolute Value

    Time frame: Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination

    Maximum LDL-C response using absolute on trial LDL-C data

  7. Emax: Change From Baseline

    Time frame: Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination

    LDL-C Emax expressed as change from baseline.

  8. Emax: Percent Change From Baseline

    Time frame: Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination

    LDL-C Emax expressed as percent change from baseline.

  9. Time to Reach Maximum LDL-C Lowering (Tmax, LDL-C)

    Time frame: Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination

    Time to LDL-C Emax

  10. Area Under the LDL-C Effect Curve (AUEC): Absolute Value

    Time frame: Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination

    AUEC is the area under the LDL-C concentration-time curve from baseline to Day 85 exprssed using absolute on trial value

  11. AUEC: Change From Baseline

    Time frame: Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination

    AUEC is the area under the LDL-C concentration-time curve from baseline to Day 85 exprssed as change from baseline

  12. AUEC: Percent Change From Baseline

    Time frame: Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination

    AUEC is the area under the LDL-C concentration-time curve from baseline to Day 85 expressed as percent change from baseline.

  13. Number of Participants With Injection Site Reactions (ISRs) by Severity

    Time frame: Day 1 to Day 85

    Acute injection site reactions (e.g, pain, pruritus, induration) were captured as adverse events (AEs). Intensity of the AE was described as mild (does not interfere with usual function), moderate (interferes to some extent with usual function), or severe (interferes significantly with participant's usual function).

  14. Number of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)

    Time frame: Day 1, Day 15, Day 29, Day 57 and Day 85/Early Termination

    A participant is ADA positive if ADA titer (log2) >=6.23. A participant is nAb positive if nAb titer (log2) >=4.32.

  15. Anti-Drug Antibody (ADA) Titer

    Time frame: Day 1, Day 15, Day 29, Day 57 and Day 85/Early Termination

    ADA titer: titers were presented as log2 reciprocal dilution at assay cutpoint.

  16. Neutralizing Antibody (nAb) Titer

    Time frame: Day 1, Day 15, Day 29, Day 57 and Day 85/Early Termination

    nAb titer: titers were presented as log2 reciprocal dilution at assay cutpoint.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 23, 2014
Registry last updated
May 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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