Safety And Tolerability Of Multiple Doses Of PF-04950615 (RN316) In Subjects With Hypercholesterolemia

Pfizer

Status and phase

Completed

Phase 1

Conditions

Hypercholesterolemia

Dyslipidemia

Treatments

Biological: PF-04950615 (RN316)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01243151

B1481009

Details and patient eligibility

About

The primary objective of this study is to evaluate the safety and tolerability of repeated doses of PF-04950615 (RN316) in study volunteers with hypercholesterolemia. PF-04950615 is an investigational drug that is currently being studied as a lipid lowering agent.

Enrollment

68 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

LDL-C must be greater or equal to 130 mg/dl
BMI must be between 18.5 and 40 kg/m2
Japanese volunteers must have 4 Japanese grand parents born in Japan

Exclusion criteria

History of cardiovascular or cerebrovascular event during the past year.
Poorly controlled type 1 or type 2 diabetes mellitus
Subjects who have taken lipid lowering therapies within the last 3 months of screening.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

68 participants in 5 patient groups, including a placebo group

A

Placebo Comparator group

Treatment:

Biological: PF-04950615 (RN316)

B

Experimental group

Treatment:

Biological: PF-04950615 (RN316)

C

Experimental group

Treatment:

Biological: PF-04950615 (RN316)

D

Experimental group

Treatment:

Biological: PF-04950615 (RN316)

E

Experimental group

Treatment:

Biological: PF-04950615 (RN316)

Trial contacts and locations

9

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