Phase 1
N=49
A Pharmacokinetic and Pharmacodynamic Study of PF-04950615 (RN316) in Subjects With Hypercholesterolemia
Hypercholesterolemia · Dyslipidemias · Hyperlipidemias · Lipid Metabolism Disorders · Metabolic Diseases
Bottom Line
View on ClinicalTrials.gov: NCT01435382 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Maximum Observed Plasma Concentration (Cmax) of PF-04950615 — 65810; 15900; 8922; 10470 nanogram per milliliter (ng/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PF-04950615 (RN316) (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of PF-04950615 |
65810; 15900; 8922; 10470 | — |
| PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615 |
1.00; 95.2; 96.0; 72.0 | — |
| PRIMARY Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of PF-04950615 |
13360000; 3420000; 2862000; 1529000 | — |
| PRIMARY Area Under the Plasma Concentration-Time Curve From Time Zero To Infinity (AUCinf) of PF-04950615 |
13510000; 3911000; 3173000; 1271000 | — |
| PRIMARY Apparent Clearance (CL/F) of PF-04950615 Subcutaneous Groups |
71.64; 80.08; 85.54 | — |
| PRIMARY Clearance (CL) of PF-04950615 Intravenous Group |
15.82 | — |
| PRIMARY Apparent Volume of Distribution (Vz/F) of PF-04950615 Subcutaneous Groups |
17770; 19400; 18400 | — |
| PRIMARY Volume of Distribution at Steady State (Vss) of PF-04950615 Intravenous Group |
4232 | — |
| PRIMARY Terminal Elimination Half-life (t1/2) of PF-04950615 |
202.4; 187.6; 153.2; 152.6 | — |
| PRIMARY Absolute Bioavailability of PF-04950615 Subcutaneous Groups |
20.60; 21.24; 19.54 | — |
| SECONDARY Absolute Value of Fasting Low-density Lipoprotein Cholesterol (LDL-C) |
154.00; 145.15; 148.31; 143.36; 147.33; 132.54 | — |
| SECONDARY 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 |
-5.93; -7.89; -7.05; -8.05; -9.85; -16.31 | — |
| SECONDARY Duration of Fasting LDL-C Suppressed Below 70 mg/dL and 100 mg/dL |
9.4; 8.7; 7.5; 4.5; 21.8; 12.3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01435382). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.