Pharmacokinetics And Relative Bioavailability Of Bococizumab (PF-04950615; RN316) When Administered To The Abdomen, Thigh Or Upper Arm
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 10/14/2017 |
| Start Date: | April 2014 |
| End Date: | November 2014 |
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.
subcutaneous injection to the abdomen, upper arm or the thigh.
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.
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Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
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Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
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