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Safety and Tolerability of BVS857 in Subjects With Insulin Resistance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01435330
First received: September 14, 2011
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

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


Condition Intervention Phase
Insulin Resistance
Drug: BVS857
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Blood glucose [ Time Frame: Continuously up to 48 hours ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: March 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BVS857 Drug: BVS857
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435330

Locations
United States, California
Novartis Investigative Site
Chula Vista, California, United States, 91910
United States, Washington
Novartis Investigative Site
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01435330     History of Changes
Other Study ID Numbers: CBVS857X2101
Study First Received: September 14, 2011
Last Updated: November 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Safety
BVS857
insulin resistance

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Insulin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014