HypercholesterolemiaPhase 1NCT02043301

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

A Phase 1 study testing Bococizumab (PF-04950615; RN316) in people with Hypercholesterolemia, run by Pfizer at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Hypercholesterolemia
What is being tested?: Bococizumab (PF-04950615; RN316)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 75 participants
Where: 6 sitesUnited States
Study dates: Apr 2014to Nov 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Anaheim Clinical Trials, LLC
Anaheim, California, 92801
Vince & Associates Clinical Research, Inc.
Overland Park, Kansas, 66211
Vince & Associates Clinical Research, Inc.
Overland Park, Kansas, 66212
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Miami Research Associates
South Miami, Florida, 33143
MRA Clinical Research, LLC
South Miami, Florida, 33143

Other trials in United States

About this study

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

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

Conditions: Hypercholesterolemia
Being tested: Bococizumab (PF-04950615; RN316)
Keywords: pharmacokinetics, bioavailability, PF-04950615
Medical subject headings: Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bococizumab (PF-04950615; RN316)Biological
Single 150 mg PF-04950615 dose administered SC to the abdomen
Bococizumab (PF-04950615; RN316)Biological
Single 150 mg PF-04950615 dose administered SC to the upper arm
Bococizumab (PF-04950615; RN316)Biological
Single 150 mg PF-04950615 dose administered SC to the thigh

Study groups in NCT02043301
Study group	Role	What they receive
Single 150 mg PF-04950615 dose administered to the abdomen	Active comparator	Not described Receives: Biological: Bococizumab (PF-04950615; RN316)
Single 150 mg PF-04950615 dose administered to the upper arm	Experimental	Not described Receives: Biological: Bococizumab (PF-04950615; RN316)
Single 150 mg PF-04950615 dose administered to the thigh	Experimental	Not described Receives: Biological: Bococizumab (PF-04950615; RN316)

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinite Time (AUCinf)
AUCinf is the area under the plasma concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time.
Measured: 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 Plasma Concentration (Cmax)
Maximum observed concentration.
Measured: 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.

Secondary outcomes (16)

Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast)
AUClast is area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration.
Measured: 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 to Reach Maximum Observed Plasma Concentration (Tmax)
Time for maximum observed concentration.
Measured: 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 (CL/F)
Apparent clearance following subcutaneous administration.
Measured: 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 (Vz/F)
Apparent volume of distribution following subcutaneous administration.
Measured: 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 (t1/2)
Terminal elimination half-life following subcutaneous administration.
Measured: 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 Low-density Lipoprotein Cholesterol LDL-C Lowering Effect (Emax): Absolute Value
Maximum LDL-C response using absolute on trial LDL-C data
Measured: 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
Emax: Change From Baseline
LDL-C Emax expressed as change from baseline.
Measured: 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
Emax: Percent Change From Baseline
LDL-C Emax expressed as percent change from baseline.
Measured: 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 Reach Maximum LDL-C Lowering (Tmax, LDL-C)
Time to LDL-C Emax
Measured: 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
Area Under the LDL-C Effect Curve (AUEC): Absolute Value
AUEC is the area under the LDL-C concentration-time curve from baseline to Day 85 exprssed using absolute on trial value
Measured: 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: Change From Baseline
AUEC is the area under the LDL-C concentration-time curve from baseline to Day 85 exprssed as change from baseline
Measured: 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: Percent Change From Baseline
AUEC is the area under the LDL-C concentration-time curve from baseline to Day 85 expressed as percent change from baseline.
Measured: 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
Number of Participants With Injection Site Reactions (ISRs) by Severity
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).
Measured: Day 1 to Day 85
Number of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)
A participant is ADA positive if ADA titer (log2) >=6.23. A participant is nAb positive if nAb titer (log2) >=4.32.
Measured: Day 1, Day 15, Day 29, Day 57 and Day 85/Early Termination
Anti-Drug Antibody (ADA) Titer
ADA titer: titers were presented as log2 reciprocal dilution at assay cutpoint.
Measured: Day 1, Day 15, Day 29, Day 57 and Day 85/Early Termination
Neutralizing Antibody (nAb) Titer
nAb titer: titers were presented as log2 reciprocal dilution at assay cutpoint.
Measured: Day 1, Day 15, Day 29, Day 57 and Day 85/Early Termination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2014Nov 2014

First posted23 Jan 2014 (estimated)
Study startApr 2014
Primary completionNov 2014
Study completionNov 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02043301
Sponsor's protocol ID: B1481024
Status last verified: Feb 2019
First submitted: 21 Jan 2014
Last updated: 31 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

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.
PubMed 37994400
Wang EQ, Plotka A, Salageanu J, Sattler C, Yunis C. Pharmacokinetics and pharmacodynamics of bococizumab, a monoclonal antibody to PCSK9, after single subcutaneous injection at three sites [NCT 02043301]. Cardiovasc Ther. 2017 Oct;35(5). doi: 10.1111/1755-5922.12278.
PubMed 28636184

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

All Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02043301
Acronym / sponsor ID: B1481024
Conditions: Hypercholesterolemia
Keywords: pharmacokinetics, bioavailability, PF-04950615
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 75 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Apr 2014 (actual)
Primary completion: Nov 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 23 Jan 2014 (estimated)
Results: Posted 31 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Single 150 mg PF-04950615 dose administered to the abdomen	Active comparator	Biological: Bococizumab (PF-04950615; RN316)
Single 150 mg PF-04950615 dose administered to the upper arm	Experimental	Biological: Bococizumab (PF-04950615; RN316)
Single 150 mg PF-04950615 dose administered to the thigh	Experimental	Biological: Bococizumab (PF-04950615; RN316)

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bococizumab (PF-04950615; RN316)Single 150 mg PF-04950615 dose administered SC to the abdomen	Biological	Single 150 mg PF-04950615 dose administered to the abdomen
Bococizumab (PF-04950615; RN316)Single 150 mg PF-04950615 dose administered SC to the upper arm	Biological	Single 150 mg PF-04950615 dose administered to the upper arm
Bococizumab (PF-04950615; RN316)Single 150 mg PF-04950615 dose administered SC to the thigh	Biological	Single 150 mg PF-04950615 dose administered to the thigh

Primary outcome

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.
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.

16 secondary outcomes

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.
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.
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 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.
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.
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
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
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
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
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: 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: 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
Number of Participants With Injection Site Reactions (ISRs) by Severity
Time frame: Day 1 to Day 85
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
Anti-Drug Antibody (ADA) Titer
Time frame: Day 1, Day 15, Day 29, Day 57 and Day 85/Early Termination
Neutralizing Antibody (nAb) Titer
Time frame: Day 1, Day 15, Day 29, Day 57 and Day 85/Early Termination

Results and safety

Results posted to the registry on 31 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bococizumab 150 mg Abdomen	25	25
Bococizumab 150 mg Thigh	25	24
Bococizumab 150 mg Upper Arm	25	25

Primary outcome: 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.. Geometric mean (Geometric Coefficient of Variation). Unit: micrograms*day/milliliter (mcg*day/mL)

Measure	Bococizumab 150 mg Abdomen n = 24	Bococizumab 150 mg Thigh n = 25	Bococizumab 150 mg Upper Arm n = 25
Value	175.9 (53)	198.9 (30)	160.3 (33)

Bococizumab 150 mg Abdomen vs Bococizumab 150 mg Thigh: Adjusted Geometric Means Ratio (%): 120.96 (90% CI 101.99 to 143.45), ANCOVA
Bococizumab 150 mg Abdomen vs Bococizumab 150 mg Upper Arm: Adjusted Geometric Means Ratio (%): 94.93 (90% CI 80.20 to 112.38), ANCOVA

Population analysed: The pharmacokinetic (PK) parameter analysis population included all enrolled participants who received at least 1 dose of study medication and that had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Primary outcome: Maximum Observed Plasma Concentration (Cmax)

Measure	Bococizumab 150 mg Abdomen n = 25	Bococizumab 150 mg Thigh n = 25	Bococizumab 150 mg Upper Arm n = 25
Value	9.68 (51)	11.89 (30)	8.14 (32)

Bococizumab 150 mg Abdomen vs Bococizumab 150 mg Thigh: Adjusted Geometric Means Ratio (%): 127.65 (90% CI 107.19 to 152.02), ANCOVA
Bococizumab 150 mg Abdomen vs Bococizumab 150 mg Upper Arm: Adjusted Geometric Means Ratio (%): 86.16 (90% CI 72.49 to 102.40), ANCOVA

Population analysed: The PK parameter analysis population included all enrolled participants who received at least 1 dose of study medication and that had at least 1 of the PK parameters of interest.

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to Day 85. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bococizumab 150 mg Abdomen	0 of 25 (0%)	13 of 25 (52%)	Not reported
Bococizumab 150 mg Thigh	1 of 25 (4%)	15 of 25 (60%)	Not reported
Bococizumab 150 mg Upper Arm	0 of 25 (0%)	12 of 25 (48%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37994400Wang 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.
Derived from this study: PubMed 28636184Wang EQ, Plotka A, Salageanu J, Sattler C, Yunis C. Pharmacokinetics and pharmacodynamics of bococizumab, a monoclonal antibody to PCSK9, after single subcutaneous injection at three sites [NCT 02043301]. Cardiovasc Ther. 2017 Oct;35(5). doi: 10.1111/1755-5922.12278.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Related trials for Hypercholesterolemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bococizumab (PF-04950615; RN316) in people with Hypercholesterolemia, run by Pfizer at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02043301, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2019.