Safety and Tolerability of BVS857 in Subjects With Insuli... | NCT01435330

Studies
Safety and Tolerability of BVS857 in Subjects With Insulin Resistance

NCT01435330

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Apr 24, 2015Estimated

Enrollment

43Actual

Phase

Phase 1

Conditions

Insulin Resistance

Interventions

BVS857
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Mar 2012Actual

Completion Date

Mar 2012Actual

First Submitted Date

Sep 14, 2011

First Submission Date that Met QC Criteria

Sep 15, 2011

First Posted Date

Sep 16, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2015

Last Update Posted Date

Apr 24, 2015Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

43Actual

Label	Type	Description	Intervention Names
BVS857	Experimental		Drug: BVS857
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
BVS857	Drug		BVS857
Placebo

Measure	Description	Time Frame
Blood glucose		Continuously up to 48 hours

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Chula Vista	California	91910	United States
Novartis Investigative Site

Condition Browse Module

MeSH Terms

ID	Term
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided