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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02813798
• Other study ID #: B5201005
• Status: Completed
• Phase: Phase 1
• Start date: June 2016
• Est. completion date: February 2018

Study information

• Verified date: June 2020
• Source: GlycoMimetics Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• Rivipansel
A single 840mg dose of Rivipansel over 20 minutes

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials, LLC	Anaheim	California
United States	Avail Clinical Research, LLC	DeLand	Florida
United States	Orlando Clinical Research Center	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GlycoMimetics Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		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
Primary	Clearance (CL)		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
Primary	Renal clearance		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
Primary	Physical examination		Baseline up to 96 hours
Primary	Assessment of adverse events		Baseline up to 28 days
Primary	Assessment of 12-lead electrocardiograms		Baseline up to 96 hours
Primary	Assessment of vital signs		Baseline up to 96 hours
Primary	Assessment of laboratory tests		Baseline up to 96 hours
Secondary	Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration		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
Secondary	Peak or maximum observed concentration		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
Secondary	Time to reach maximum concentration		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
Secondary	Terminal half life		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
Secondary	Apparent volume of distribution		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
Secondary	Amount of unchanged drug excreted into urine over 96 hours		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
Secondary	Percentage of dose excreted unchanged into urine over 96 hours		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
Secondary	Fraction of unbound		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