A Study to Evaluate the Effect of Age on the Pharmacokinetics, Safety and Tolerability of IV Rivipansel.

NCT ID: NCT02998099

Last Updated: 2020-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-03-31

Brief Summary

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The purpose of this study is to evaluate the effect of age on PK, safety and tolerability of IV rivipansel.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Aged 18-45 years

A single dose of IV rivipansel over 20 minutes.

Group Type EXPERIMENTAL

Rivipansel

Intervention Type DRUG

A single dose of IV rivipansel over 20 minutes.

Aged 65 and older

A single dose of IV rivipansel over 20 minutes.

Group Type EXPERIMENTAL

Rivipansel

Intervention Type DRUG

A single dose of IV rivipansel over 20 minutes.

Interventions

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Rivipansel

A single dose of IV rivipansel over 20 minutes.

Intervention Type DRUG

Other Intervention Names

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GMI-1070

Eligibility Criteria

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Inclusion Criteria

* Healthy female subjects of non-childbearing potential or healthy male subjects who are between the ages of 18-45 years or 65 years of age or older.
* Body mass index (BMI) of 17.5 to 40 kg/m2

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Pregnant females; breastfeeding female subjects; male subjects with partners currently pregnant
* Treatment with another investigational drug within 30 days or 5 half-lives preceding the dose of study medication
* Blood donation within 60 days prior to dosing.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlycoMimetics Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Orlando Clinical Research Center

Orlando, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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B5201004

Identifier Type: -

Identifier Source: org_study_id

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