Safety and Tolerability of BVS857 in Subjects With Insulin Resistance

Phase 1CompletedNCT01435330

Novartis Pharmaceuticals43 enrolled

Overview

The study will assess the safety, tolerability, drug label and effect in subjects with and without insulin resistance.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Insulin Resistance

Interventions

BVS857DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male and female subjects with insulin resistance * Subjects with controlled hypertension and hyperlipidemia Exclusion Criteria: * Smokers * History of drug or alcohol use * Autonomic dysfunction * Significant illness or cardiovascular disease * Immunodeficiency disease Other protocol-defined inclusion/exclusion criteria may apply

Locations (2)

Novartis Investigative Site

Chula Vista, California, United States

Novartis Investigative Site

Tacoma, Washington, United States

Outcomes

Primary Outcomes

Blood glucose

Time frame: Continuously up to 48 hours

Data from ClinicalTrials.gov

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