Safety and Tolerability of BVS857 in Subjects With Insulin Resistance
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
1 other identifier
interventional
43
1 country
2
Brief Summary
The study will assess the safety, tolerability, drug label and effect in subjects with and without insulin resistance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 14, 2011
CompletedFirst Posted
Study publicly available on registry
September 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedApril 24, 2015
April 1, 2015
1 year
September 14, 2011
April 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood glucose
Continuously up to 48 hours
Study Arms (2)
BVS857
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Healthy male and female subjects with insulin resistance
- Subjects with controlled hypertension and hyperlipidemia
You may not qualify if:
- Smokers
- History of drug or alcohol use
- Autonomic dysfunction
- Significant illness or cardiovascular disease
- Immunodeficiency disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Novartis Investigative Site
Chula Vista, California, 91910, United States
Novartis Investigative Site
Tacoma, Washington, 98418, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2011
First Posted
September 16, 2011
Study Start
March 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
April 24, 2015
Record last verified: 2015-04