HypercholesterolemiaPhase 1NCT01435382

A Pharmacokinetic and Pharmacodynamic Study of PF-04950615 (RN316) in Subjects With Hypercholesterolemia

A Phase 1 study testing PF-04950615 (RN316) in people with Hypercholesterolemia and Dyslipidemias, run by Pfizer at 7 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 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Hypercholesterolemia, Dyslipidemias, Hyperlipidemias
What is being tested?: PF-04950615 (RN316)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 49 participants
Where: 7 sitesUnited States
Study dates: Oct 2011to Apr 2012
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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)

Who cannot join

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.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

PAREXEL International - Baltimore Early Phase Clinical Unit
Baltimore, Maryland, 21225
Profil Institute for Clinical Research, Inc.
Chula Vista, California, 91911
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, 45212
Jasper Clinic, Inc.
Kalamazoo, Michigan, 49007
Elite Research Institute
Miami, Florida, 33169
Vince and Associates Clinical Research
Overland Park, Kansas, 66212
Prism Research
Saint Paul, Minnesota, 55114

Other trials in United States

About this study

Official title: A Phase 1, Open-label, Randomized, Single Dose, Parallel Group Study To Assess The Pharmacokinetics And Pharmacodynamics Of Pf-04950615 Following Subcutaneous And Intravenous Doses In Adult Subjects With Hypercholesterolemia

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.

Conditions: Hypercholesterolemia, Dyslipidemias, Hyperlipidemias, Lipid Metabolism Disorders, Metabolic Diseases
Being tested: PF-04950615 (RN316)
Keywords: PF-04950615, RN316
Medical subject headings: Hypercholesterolemia, Dyslipidemias, Hyperlipidemias, Lipid Metabolism Disorders, Metabolic Diseases

What participants receive

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

PF-04950615 (RN316)Biological
Dose A - single-dose intravenous infusion
PF-04950615 (RN316)Biological
Dose B - single-dose subcutaneous injection
PF-04950615 (RN316)Biological
Dose C - single-dose subcutaneous injection
PF-04950615 (RN316)Biological
Dose D - single-dose subcutaneous injection

Study groups in NCT01435382
Study group	Role	What they receive
Group A	Experimental	Not described Receives: Biological: PF-04950615 (RN316)
Group B	Experimental	Not described Receives: Biological: PF-04950615 (RN316)
Group C	Experimental	Not described Receives: Biological: PF-04950615 (RN316)
Group D	Experimental	Not described Receives: Biological: PF-04950615 (RN316)

What is being measured

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

Maximum Observed Plasma Concentration (Cmax) of PF-04950615
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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 was the average of observations collected on Days 7 and 1 prior to the study treatment administration.
Measured: 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
Measured: Day 1 up to Day 85

Timeline

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

Oct 2011Apr 2012

First posted16 Sep 2011 (estimated)
Study startOct 2011
Primary completionFeb 2012
Study completionApr 2012

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: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01435382
Sponsor's protocol ID: B1481006
Status last verified: Oct 2017
First submitted: 7 Sep 2011
Last updated: 23 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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
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.
PubMed 28181260

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 23 Jul 2018. 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 The Pharmacokinetics And Pharmacodynamics Of Pf-04950615 Following Subcutaneous And Intravenous Doses In Adult Subjects With Hypercholesterolemia
ClinicalTrials.gov ID: NCT01435382
Acronym / sponsor ID: B1481006
Conditions: Hypercholesterolemia, Dyslipidemias, Hyperlipidemias, Lipid Metabolism Disorders, Metabolic Diseases
Keywords: PF-04950615, RN316
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Oct 2011 (actual)
Primary completion: Feb 2012 (actual)
Study completion: Apr 2012 (actual)
First posted: 16 Sep 2011 (estimated)
Results: Posted 23 Jul 2018

Clinical summary

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

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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
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)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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)

Key exclusion criteria (4 listed)

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.

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
PF-04950615 (RN316)Dose A - single-dose intravenous infusion	Biological	Group A
PF-04950615 (RN316)Dose B - single-dose subcutaneous injection	Biological	Group B
PF-04950615 (RN316)Dose C - single-dose subcutaneous injection	Biological	Group C
PF-04950615 (RN316)Dose D - single-dose subcutaneous injection	Biological	Group D

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of PF-04950615
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 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.
Clearance (CL) of PF-04950615 Intravenous Group
Time frame: 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 of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Apparent Volume of Distribution (Vz/F) of PF-04950615 Subcutaneous Groups
Time frame: 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 (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.
Volume of Distribution at Steady State (Vss) of PF-04950615 Intravenous Group
Time frame: 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 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.
Terminal Elimination Half-life (t1/2) of PF-04950615
Time frame: 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
t1/2 is the time measured for the plasma concentration of drug to decrease by one half.
Absolute Bioavailability of PF-04950615 Subcutaneous Groups
Time frame: 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
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.

3 secondary outcomes

Absolute Value of Fasting Low-density Lipoprotein Cholesterol (LDL-C)
Time frame: 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
Time frame: 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
Time frame: Day 1 up to Day 85

Results and safety

Results posted to the registry on 23 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PF-04950615 IV 200 mg	12	11
PF-04950615 SC 200 mg (2 Injections of 1 mL)	13	11
PF-04950615 SC 200 mg (1 Injection of 2 mL)	13	12
PF-04950615 SC 100 mg (1 Injection of 1 mL)	11	10

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of PF-04950615

Time frame: 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. Mean (Standard Deviation). Unit: nanogram per milliliter (ng/mL)

Measure	PF-04950615 IV 200 mg n = 12	PF-04950615 SC 200 mg (2 Injections of 1 mL) n = 13	PF-04950615 SC 200 mg (1 Injection of 2 mL) n = 13	PF-04950615 SC 100 mg (1 Injection of 1 mL) n = 11
Value	65810 (14047)	15900 (18289)	8922 (4016.4)	10470 (18219)

Population analysed: Pharmacokinetic (PK) parameter analysis population included all participants randomized and treated who have at least 1 of the PK parameters of primary interest.

Primary outcome: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615

Time frame: 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. Median (Full Range). Unit: hour

Measure	PF-04950615 IV 200 mg n = 12	PF-04950615 SC 200 mg (2 Injections of 1 mL) n = 13	PF-04950615 SC 200 mg (1 Injection of 2 mL) n = 13	PF-04950615 SC 100 mg (1 Injection of 1 mL) n = 11
Value	1.00 (1.00 to 1.08)	95.2 (8.00 to 167)	96.0 (71.0 to 167)	72.0 (8.00 to 504)

Population analysed: PK parameter analysis population included all participants randomized and treated who have at least 1 of the PK parameters of primary interest.

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

Time frame: 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. Mean (Standard Deviation). Unit: nanogram*hour per milliliter

Measure	PF-04950615 IV 200 mg n = 11	PF-04950615 SC 200 mg (2 Injections of 1 mL) n = 13	PF-04950615 SC 200 mg (1 Injection of 2 mL) n = 13	PF-04950615 SC 100 mg (1 Injection of 1 mL) n = 11
Value	13360000 (3635200)	3420000 (2024100)	2862000 (1638000)	1529000 (849890)

Population analysed: PK parameter analysis population included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. Here 'N' (Overall Number of participants analyzed) signifies those participants who were evaluable for this outcome measure.

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

Time frame: 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. Mean (Standard Deviation). Unit: nanogram*hour per milliliter

Measure	PF-04950615 IV 200 mg n = 11	PF-04950615 SC 200 mg (2 Injections of 1 mL) n = 10	PF-04950615 SC 200 mg (1 Injection of 2 mL) n = 11	PF-04950615 SC 100 mg (1 Injection of 1 mL) n = 7
Value	13510000 (3644400)	3911000 (2008600)	3173000 (1728000)	1271000 (411160)

Population analysed: PK parameter analysis population included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. Here 'N' signifies those participants who were evaluable for this measure.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PF-04950615 IV 200 mg	0 of 12 (0%)	7 of 12 (58.3%)	Not reported
PF-04950615 SC 200 mg (2 Injections of 1 mL)	0 of 13 (0%)	7 of 13 (53.8%)	Not reported
PF-04950615 SC 200 mg (1 Injection of 2 mL)	0 of 13 (0%)	8 of 13 (61.5%)	Not reported
PF-04950615 SC 100 mg (1 Injection of 1 mL)	0 of 11 (0%)	6 of 11 (54.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
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 28181260Udata 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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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

7 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 PF-04950615 (RN316) in people with Hypercholesterolemia and Dyslipidemias, run by Pfizer at 7 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 2 inclusion and 4 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 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 23 Jul 2018). 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?

Maximum Observed Plasma Concentration (Cmax) of PF-04950615 (time frame: 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). The study lists 10 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 NCT01435382, 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 23 Jul 2018.