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

Pfizer

Status and phase

Completed

Phase 1

Conditions

Metabolic Diseases

Hyperlipidemias

Lipid Metabolism Disorders

Dyslipidemias

Hypercholesterolemia

Treatments

Biological: PF-04950615 (RN316)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01435382

B1481006

Details and patient eligibility

About

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.

Enrollment

49 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

49 participants in 4 patient groups

Group A

Experimental group

Treatment:

Biological: PF-04950615 (RN316)

Group B

Experimental group

Treatment:

Biological: PF-04950615 (RN316)

Group C

Experimental group

Treatment:

Biological: PF-04950615 (RN316)

Group D

Experimental group

Treatment:

Biological: PF-04950615 (RN316)

Trial contacts and locations

7

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