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kg, kg

Phase 1

Hypercholesterolemia | Unknown | Cardiovascular |Pfizer, Inc.|Last Updated: Mar 1, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

kg, kg · 1 trial · 2 indications

Phase 1 1
NCT01163851Pharmacokinetic And Pharmacodynamic Study Of A Single-Dose Of PF-04950615 (RN316) In Combination With AtorvastatinHypercholesterolemia
COMPLETED25 Analytics
PHASE1COMPLETED
Pharmacokinetic And Pharmacodynamic Study Of A Single-Dose Of PF-04950615 (RN316) In Combination With Atorvastatin
HypercholesterolemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04950615
0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615
0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Maximum Observed Plasma Concentration (Cmax) of PF-04950615
0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Plasma Decay Half-Life (t1/2) of PF-04950615
0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64

Plasma decay half-life is the time measured for the plasma concentration of PF-04950615 to decrease by one half.

Systemic Clearance (CL) of PF-04950615
0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64

CL is a quantitative measure of the rate at which a drug substance is removed from the body.

Volume of Distribution at Steady State (Vss) of PF-04950615
0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64

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 blood concentration of a drug.

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of PF-04950615
0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Atorvastatin
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4

AUCtau was the AUC from time 0 to the end of the dosing interval, where the dosing interval was 12 hours.

Time to Reach Maximum Observed Plasma Concentration (Tmax) of Atorvastatin
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7
Maximum Observed Plasma Concentration (Cmax) of Atorvastatin
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7
Plasma Decay Half-Life (t1/2) of Atorvastatin
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7

Plasma decay half-life is the time measured for the plasma concentration of atorvastatin to decrease by one half.

Apparent Oral Clearance (CL/F) of Atorvastatin
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.

Apparent Volume of Distribution (Vz/F) of Atorvastatin
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4

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. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.

Secondary Endpoints

Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PF-04950615 (RN316)EXPERIMENTAL -

Interventions

NameTypeDescription
4 mg/kgBIOLOGICALRN316 10 mg/ml vial sd. Infusion based on weight Infusion duration = 60 minutes.
0.5 mg/kgBIOLOGICALRN316 10 mg/ml vial sd. Infusion based on weight Infusion duration = 60 minutes.
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersYes
Study Sites5

Inclusion Criteria: * On stable doses of atorvastatin (40 mg daily) for 45 days prior to Day 1. * BMI 18.5 to 40 kg/m2 inclusive, and body weight equal or lower than 150 kg. Exclusion Criteria: * History of a cardiovascular event (e.g., MI ) during the past year. * Poorly controlled Type 1 or Typ...

Countries:United States
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Frequently asked questions about kg, kg

What is 1 mg, 5 mg, 10 mg used for?

1 mg, 5 mg, 10 mg is an investigational drug being studied for use in meningococcal vaccine, non-Hodgkin lymphoma, growth disorder, acute otitis media, hypogonadism, and healthy volunteers. It is currently in Phase 1 clinical development.

Who makes 1 mg, 5 mg, 10 mg?

1 mg, 5 mg, 10 mg is being developed by Pfizer, Inc. (NYSE: PFE). The drug is currently in Phase 1 clinical development.

What phase is 1 mg, 5 mg, 10 mg in?

1 mg, 5 mg, 10 mg is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities.

What clinical trials is 1 mg, 5 mg, 10 mg in?

1 mg, 5 mg, 10 mg has been studied in clinical trials including NCT00037791, NCT00039910, NCT00174421, and NCT01163851. These trials have investigated its use in conditions such as thrombocytopenia, non-Hodgkin lymphoma, growth disorder, and hypercholesterolemia.

Is 1 mg, 5 mg, 10 mg the same as PN-152,243?

1 mg, 5 mg, 10 mg is also known as PN-152,243 and PN-196,444 in clinical trials. These names refer to the same investigational drug being developed by Pfizer.