Safety and Tolerability of GBR 900 in a Single Ascending... | NCT02235727

Studies
Safety and Tolerability of GBR 900 in a Single Ascending Dose Study in Healthy Subjects

NCT02235727

Sponsor

Glenmark Pharmaceuticals Ltd. India

Status

Completed

Last Update Posted

Jan 24, 2017Estimated

Enrollment

37Actual

Phase

Phase 1

Conditions

Healthy

Interventions

GBR 900
Placebo

Countries

United Kingdom

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

ID	Type	Description	Link
2013-005480-31	EudraCT Number

Status Module

Record Verification Date

Jan 2017

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

Jul 2014

Primary Completion Date

Nov 2016Actual

Completion Date

Nov 2016Actual

First Submitted Date

Aug 7, 2014

First Submission Date that Met QC Criteria

Sep 8, 2014

First Posted Date

Sep 10, 2014Estimated

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

Jan 23, 2017

Last Update Posted Date

Jan 24, 2017Estimated

Name	Class
Glenmark Pharmaceuticals S.A.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A Single Dose Study of GBR 900 in Healthy Volunteers.

Detailed Description

This is a phase I study of GBR 900 in healthy volunteers. The purposes of this study are to look at safety, how well the study drug is tolerated, how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it when given to humans. Information about any side effects that may occur will also be collected. Each participant will remain in the study for approximately 3.5 months. This study is for research purposes only and is not intended to treat any medical condition.

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

37Actual

Label	Type	Description	Intervention Names
GBR 900	Experimental	Test treatment GBR 900	Drug: GBR 900
Placebo	Placebo Comparator	Placebo Treatment	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
GBR 900	Drug		GBR 900
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Drug related adverse events (AEs) or any serious AEs	All treatment - emergent adverse events (TEAEs), occuring during the study, in terms of nature, onset, duration, severity, relationship and outcome of adverse events and serious adverse events in adult healthy volunteers from baseline to day 71.	71 days

Secondary Outcomes

Measure	Description	Time Frame
Maximum Concentration (Cmax) of single ascending doses of GBR 900 in adult healthy volunteers		Pre-dose and post-dose at planned multiple time points from 2 hours to 168 hours and from day 15 until day 71
Area Under Curve [(AUC (0-∞) and AUC (0-t)] of single ascending doses of GBR 900 in adult healthy volunteers

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Body mass index (BMI) within the range 18.5-32 kg/m2 (inclusive); weight must be ≥ 50 kg.
Men and women aged between 18 and 55 years (inclusive). Female subjects must be of non-child-bearing potential
Subjects who are otherwise healthy and free from clinically significant illness or disease as determined by medical history, vital signs, physical examinations, and other tests performed by the investigator.

Exclusion Criteria:

Subjects with a history of neuropathy or otherwise present with risk factors for neurological toxicity like chronic alcoholism or clinically significant neurological (e.g. dementia, cognitive decline, seizure disorders) or psychiatric disorders.
Subjects with a recent history of live vaccination within the past 3 month or presence of active infections within the previous month.
Subjects with previous exposure to antibody therapies or administration of immunoglobulins (Ig) within 6 months of randomization.
Subjects with a history of or presence of inflammatory disease or rheumatological diseases or joint diseases including OA or any undiagnosed pain in joints.
Subjects with a current and/or recent history of arthralgia or a history of fibromyalgia, migraine, neuralgia, or systemic painful conditions, or medical or arthritic conditions or any undiagnosed pain or systemic inflammatory disorders.
Any evidence of organ dysfunction or any clinically significant deviation from the normal in history, physical or neurological determinations or investigations or has a clinical condition or receiving therapy that, in the opinion of the Investigator, would make the subjects unsuitable for study.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided