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Safety and Tolerability of BVS857 in Subjects With Insulin Resistance

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01435330
First received: September 14, 2011
Last updated: October 9, 2012
Last verified: October 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Novartis:

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

Estimated Enrollment: 72
Study Start Date: September 2011
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 64 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01435330

Locations
United States, Washington
Novartis Clinical 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: October 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Safety
BVS857
insulin resistance

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

ClinicalTrials.gov processed this record on June 17, 2013