A Study to Evaluate the Effect of IV Doses of Rivipansel on Subjects With Renal Impairment and in Healthy Subjects
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
1 other identifier
interventional
28
1 country
3
Brief Summary
The purpose of this study is to determine the effect of renal impairment on rivipansel.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2016
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 15, 2016
CompletedFirst Posted
Study publicly available on registry
June 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedJune 18, 2020
June 1, 2020
1.7 years
June 15, 2016
June 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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
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
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
Physical examination
Baseline up to 96 hours
Assessment of adverse events
Baseline up to 28 days
Assessment of 12-lead electrocardiograms
Baseline up to 96 hours
Assessment of vital signs
Baseline up to 96 hours
Assessment of laboratory tests
Baseline up to 96 hours
Secondary Outcomes (8)
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
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
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
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
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
- +3 more secondary outcomes
Study Arms (4)
Mild Renal Impairment
EXPERIMENTALA single dose of IV Rivipansel over 20 minutes
Moderate Renal Impairment
EXPERIMENTALA single dose of IV Rivipansel over 20 minutes
Severe Renal Impairment
EXPERIMENTALA single dose of IV Rivipansel over 20 minutes
Normal Renal Functions
EXPERIMENTALA single dose of IV Rivipansel over 20 minutes
Interventions
A single 840mg dose of Rivipansel over 20 minutes
Eligibility Criteria
You may qualify if:
- Female subjects of non-childbearing potential or male subjects
- Body Mass Index (BMI) of 17.5 to 40.0 kg/m2
- Stable renal function
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
Avail Clinical Research, LLC
DeLand, Florida, 32720, United States
Orlando Clinical Research Center
Orlando, Florida, 32809, United States
Related Publications (1)
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.
PMID: 32579796DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2016
First Posted
June 27, 2016
Study Start
June 1, 2016
Primary Completion
February 1, 2018
Study Completion
February 1, 2018
Last Updated
June 18, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share