Safety and Tolerability of BVS857 in Subjects With Insulin Resistance

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

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Key information

Conditions

Insulin Resistance Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Chula Vista, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BVS857

Drug

Placebo

Drug

Primary outcomes

Blood glucose

Time frame: Continuously up to 48 hours

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Explore the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Parenterally Administered BVS857 in Healthy Subjects Without and With Insulin Resistance

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Sep 16, 2011
Registry last updated: Apr 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed