A Study to Evaluate the PK, Safety and Tolerability of GM... | NCT02703051

Studies
A Study to Evaluate the PK, Safety and Tolerability of GMI-1271 With and Without Filgrastim in Healthy Adult Subjects

NCT02703051

Sponsor

GlycoMimetics Incorporated

Status

Completed

Last Update Posted

Feb 27, 2018Actual

Enrollment

54Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

GMI-1271
Filgrastim
Placebo Injection
Placebo Infusion

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

Feb 2018

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

Nov 2015Actual

Primary Completion Date

Aug 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Mar 3, 2016

First Submission Date that Met QC Criteria

Mar 8, 2016

First Posted Date

Mar 9, 2016Estimated

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

Feb 23, 2018

Last Update Posted Date

Feb 27, 2018Actual

Name	Class
Celerion	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

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

Phase 1, open-label, parallel, active-controlled, multiple IV dose, proof of concept study conducted at one study center in the United States (US).

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

54Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GMI-1271	Experimental	GMI-1271	Drug: GMI-1271 Drug: Placebo Injection
Filgrastim	Active Comparator	Filgrastim	Drug: Filgrastim Drug: Placebo Infusion
GMI-1271 with Filgrastim	Experimental	GMI-1271 with Filgrastim	Drug: GMI-1271 Drug: Filgrastim

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GMI-1271	Drug		GMI-1271 GMI-1271 with Filgrastim
Filgrastim

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement of subsets of WBC		10 days

Secondary Outcomes

Measure	Description	Time Frame
Number of adverse events as a measure of safety and tolerability		19 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy adult male and/or females, 19 to 60 years of age, inclusive.
Medically healthy with no clinically significant screening results as deemed by the PI.

Exclusion Criteria:

History of presence of clinically significant medical condition or disease in the opinion of the PI.
Alcoholism or drug abuse.
Liver disease.
Female subjects who are pregnant or lactating.
Known history or evidence of active hepatitis A, B, or C or HIV.
Clinically significant cardiovascular disease.
Participation in another clinical trial within 28 days prior to the first dose of GMI-1271 or filgrastim, whichever occurs first.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Laura Sterling, MD	Celerion	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Celerion		Lincoln	Nebraska	68502	United States

Intervention Browse Module

MeSH Terms

ID	Term
C000654285	uproleselan
D000069585	Filgrastim

Ancestor Terms

ID	Term
D016179	Granulocyte Colony-Stimulating Factor
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates

Browse Leaves

Not provided

Browse Branches

Not provided