Safety and Tolerability of BVS857 in Subjects With Insulin Resistance

Insulin Resistance Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01435330
• Other study ID #: CBVS857X2101
• Status: Completed
• Phase: Phase 1
• First received: September 14, 2011
• Last updated: April 23, 2015
• Start date: March 2011
• Est. completion date: March 2012

Study information

• Verified date: April 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Drug:
• BVS857

• Placebo

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Chula Vista	California
United States	Novartis Investigative Site	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose		Continuously up to 48 hours	Yes