A Study to Evaluate the Effect of IV Doses of Rivipansel in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function

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NCT02871570

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Study Location
Orlando Clincial Research Center
Orlando, Florida, 32809, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Moderate Hepatic Impairment, Normal Hepatic Function
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Female subjects of non-childbearing potential or male subjects

- Body Mass Index (BMI) of 17.5 to 40.0 kg/m2

- Normal Hepatic function for the healthy subjects

- Stable Hepatic Impairment for the subjects with moderate hepatic impairment

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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


- A positive urine drug screen for illicit drugs

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Moderate Hepatic Impairment, Normal Hepatic FunctionA Study to Evaluate the Effect of IV Doses of Rivipansel in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function
NCT02871570
  1. Orlando, Florida
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Effect of IV Doses of Rivipansel in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function
Official Title  ICMJE A Phase 1, Non-randomized, Open-label, Parallel-group Single-dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Intravenous Rivipansel (Pf-06460031) In Subjects With Moderate Hepatic Impairment And In Healthy Subjects With Normal Hepatic Function
Brief Summary The purpose of this study is to determine the effect of hepatic impairment on rivipansel PK and safety.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Moderate Hepatic Impairment
  • Normal Hepatic Function
Intervention  ICMJE Drug: Rivipansel
A single dose of IV Rivipansel over 20 minutes
Other Name: GMI-1070
Study Arms  ICMJE
  • Experimental: Moderate Hepatic Impairment
    A single dose of IV Rivipansel over 20 minutes
    Intervention: Drug: Rivipansel
  • Experimental: Normal Hepatic Function
    A single dose of IV Rivipansel over 20 minutes
    Intervention: Drug: Rivipansel
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 17, 2016)		16
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female subjects of non-childbearing potential or male subjects

    • Body Mass Index (BMI) of 17.5 to 40.0 kg/m2
    • Normal Hepatic function for the healthy subjects
    • Stable Hepatic Impairment for the subjects with moderate hepatic impairment

Exclusion Criteria:

  • 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
  • A positive urine drug screen for illicit drugs
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02871570
Other Study ID Numbers  ICMJE B5201006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlycoMimetics Incorporated
Study Sponsor  ICMJE GlycoMimetics Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account GlycoMimetics Incorporated
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP