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A Study to Evaluate the Effect of IV Doses of Rivipansel on Subjects With Renal Impairment and in Healthy Subjects

Primary Purpose

Renal Impairment, Healthy

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Rivipansel

About this trial

This is an interventional other trial for Renal Impairment focused on measuring Renal Insufficiency

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Female subjects of non-childbearing potential or male subjects
Body Mass Index (BMI) of 17.5 to 40.0 kg/m2
Stable renal function

Exclusion Criteria:

A positive urine drug screen for illicit drugs
Treatment with an investigational drug within 30 days of the dose of study medication
Pregnant females, breastfeeding female subjects and male subjects with partners currently pregnant
Use of herbal supplements in the 28 days prior to the dose of study medication
Blood donation (excluding plasma donation) of approximately 1 pint or more within 56 days prior to study medication
Requiring dialysis

Sites / Locations

Anaheim Clinical Trials, LLC
Avail Clinical Research, LLC
Orlando Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Mild Renal Impairment

Moderate Renal Impairment

Severe Renal Impairment

Normal Renal Functions

Arm Description

A single dose of IV Rivipansel over 20 minutes

Outcomes

Primary Outcome Measures

Area under the concentration-time curve from time 0 to infinity or area under the concentration-time curve from time 0 to the time of the last quantifiable concentration, as data permit

Clearance (CL)

Renal clearance

Physical examination

Assessment of adverse events

Assessment of 12-lead electrocardiograms

Assessment of vital signs

Assessment of laboratory tests

Secondary Outcome Measures

Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration

Peak or maximum observed concentration

Time to reach maximum concentration

Terminal half life

Apparent volume of distribution

Amount of unchanged drug excreted into urine over 96 hours

Percentage of dose excreted unchanged into urine over 96 hours

Fraction of unbound

Full Information

NCT ID

NCT02813798

First Posted

June 15, 2016

Last Updated

June 16, 2020

Sponsor

GlycoMimetics Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT02813798

Brief Title

A Study to Evaluate the Effect of IV Doses of Rivipansel on Subjects With Renal Impairment and in Healthy Subjects

Official Title

A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE DOSE STUDY TO EVALUATE THE EFFECT OF RENAL IMPAIRMENT ON THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF RIVIPANSEL (PF-06460031) IN SUBJECTS WITH RENAL IMPAIRMENT AND IN HEALTHY SUBJECTS

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

June 2016 (Actual)

Primary Completion Date

February 2018 (Actual)

Study Completion Date

February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlycoMimetics Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine the effect of renal impairment on rivipansel.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Impairment, Healthy

Keywords

Renal Insufficiency

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mild Renal Impairment

Arm Type

Experimental

Arm Description

A single dose of IV Rivipansel over 20 minutes

Arm Title

Moderate Renal Impairment

Arm Type

Experimental

Arm Description

A single dose of IV Rivipansel over 20 minutes

Arm Title

Severe Renal Impairment

Arm Type

Experimental

Arm Description

A single dose of IV Rivipansel over 20 minutes

Arm Title

Normal Renal Functions

Arm Type

Experimental

Arm Description

A single dose of IV Rivipansel over 20 minutes

Intervention Type

Drug

Intervention Name(s)

Rivipansel

Other Intervention Name(s)

GMI-1070

Intervention Description

A single 840mg dose of Rivipansel over 20 minutes

Primary Outcome Measure Information:

Title

Area under the concentration-time curve from time 0 to infinity or area under the concentration-time curve from time 0 to the time of the last quantifiable concentration, as data permit

Time Frame

Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration

Title

Clearance (CL)

Time Frame

Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration

Title

Renal clearance

Time Frame

Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration

Title

Physical examination

Time Frame

Baseline up to 96 hours

Title

Assessment of adverse events

Time Frame

Baseline up to 28 days

Title

Assessment of 12-lead electrocardiograms

Time Frame

Baseline up to 96 hours

Title

Assessment of vital signs

Time Frame

Baseline up to 96 hours

Title

Assessment of laboratory tests

Time Frame

Baseline up to 96 hours

Secondary Outcome Measure Information:

Title

Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration

Time Frame

Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration

Title

Peak or maximum observed concentration

Time Frame

Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration

Title

Time to reach maximum concentration

Time Frame

Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration

Title

Terminal half life

Time Frame

Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration

Title

Apparent volume of distribution

Time Frame

Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration

Title

Amount of unchanged drug excreted into urine over 96 hours

Time Frame

Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration

Title

Percentage of dose excreted unchanged into urine over 96 hours

Time Frame

Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration

Title

Fraction of unbound

Time Frame

Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 H following single dose administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Female subjects of non-childbearing potential or male subjects Body Mass Index (BMI) of 17.5 to 40.0 kg/m2 Stable renal function Exclusion Criteria: A positive urine drug screen for illicit drugs Treatment with an investigational drug within 30 days of the dose of study medication Pregnant females, breastfeeding female subjects and male subjects with partners currently pregnant Use of herbal supplements in the 28 days prior to the dose of study medication Blood donation (excluding plasma donation) of approximately 1 pint or more within 56 days prior to study medication Requiring dialysis

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Anaheim Clinical Trials, LLC

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Avail Clinical Research, LLC

City

DeLand

State/Province

Florida

ZIP/Postal Code

32720

Country

United States

Facility Name

Orlando Clinical Research Center

City

Orlando

State/Province

Florida

ZIP/Postal Code

32809

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32579796

Citation

Tammara BK, Ryan K, Plotka A, Shafer FE, Wei H, Readett D, Fang A, Korth-Bradley JM. Effect of Renal or Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Intravenous Rivipansel. Clin Pharmacol Drug Dev. 2020 Nov;9(8):918-928. doi: 10.1002/cpdd.842. Epub 2020 Jun 24.

Results Reference

derived

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A Study to Evaluate the Effect of IV Doses of Rivipansel on Subjects With Renal Impairment and in Healthy Subjects

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