- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02813798
A Study to Evaluate the Effect of IV Doses of Rivipansel on Subjects With Renal Impairment and in Healthy Subjects
June 16, 2020 updated by: GlycoMimetics Incorporated
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
The purpose of this study is to determine the effect of renal impairment on rivipansel.
Study Overview
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Anaheim, California, United States, 92801
- Anaheim Clinical Trials, LLC
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Florida
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DeLand, Florida, United States, 32720
- Avail Clinical Research, LLC
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Orlando, Florida, United States, 32809
- Orlando Clinical Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Mild Renal Impairment
A single dose of IV Rivipansel over 20 minutes
|
A single 840mg dose of Rivipansel over 20 minutes
Other Names:
|
EXPERIMENTAL: Moderate Renal Impairment
A single dose of IV Rivipansel over 20 minutes
|
A single 840mg dose of Rivipansel over 20 minutes
Other Names:
|
EXPERIMENTAL: Severe Renal Impairment
A single dose of IV Rivipansel over 20 minutes
|
A single 840mg dose of Rivipansel over 20 minutes
Other Names:
|
EXPERIMENTAL: Normal Renal Functions
A single dose of IV Rivipansel over 20 minutes
|
A single 840mg dose of Rivipansel over 20 minutes
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
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
|
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
|
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
|
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
|
Physical examination
Time Frame: Baseline up to 96 hours
|
Baseline up to 96 hours
|
Assessment of adverse events
Time Frame: Baseline up to 28 days
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Baseline up to 28 days
|
Assessment of 12-lead electrocardiograms
Time Frame: Baseline up to 96 hours
|
Baseline up to 96 hours
|
Assessment of vital signs
Time Frame: Baseline up to 96 hours
|
Baseline up to 96 hours
|
Assessment of laboratory tests
Time Frame: Baseline up to 96 hours
|
Baseline up to 96 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 1, 2016
Primary Completion (ACTUAL)
February 1, 2018
Study Completion (ACTUAL)
February 1, 2018
Study Registration Dates
First Submitted
June 15, 2016
First Submitted That Met QC Criteria
June 22, 2016
First Posted (ESTIMATE)
June 27, 2016
Study Record Updates
Last Update Posted (ACTUAL)
June 18, 2020
Last Update Submitted That Met QC Criteria
June 16, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B5201005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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