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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

Last updated on May 9, 2018

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Study Location
Orlando Clincial Research Center
Orlando, Florida, 32809 United States
Contact
1-800-718-1021
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

NCT02871570
Pfizer
Completed
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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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
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
The purpose of this study is to determine the effect of hepatic impairment on rivipansel PK and safety.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
  • Moderate Hepatic Impairment
  • Normal Hepatic Function
Drug: Rivipansel
A single dose of IV Rivipansel over 20 minutes
Other Name: GMI-1070
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
March 23, 2017
February 26, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02871570
B5201006
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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Contact

[email protected]



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