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A Study to Evaluate the Effect of Age on the Pharmacokinetics, Safety and Tolerability of IV Rivipansel.

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Orlando Clinical 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.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy female subjects of non-childbearing potential or healthy male subjects who are
between the ages of 18-45 years or 65 years of age or older.

- Body mass index (BMI) of 17.5 to 40 kg/m2

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

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at the time of dosing).

- Pregnant females; breastfeeding female subjects; male subjects with partners currently
pregnant

- Treatment with another investigational drug within 30 days or 5 half-lives preceding
the dose of study medication

- Blood donation within 60 days prior to dosing.

NCT02998099
Pfizer
Completed
A Study to Evaluate the Effect of Age on the Pharmacokinetics, Safety and Tolerability of IV Rivipansel.

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A Study to Evaluate the Effect of Age on the Pharmacokinetics, Safety and Tolerability of IV Rivipansel.
A Phase 1, Non-randomized, Open-label, Parallel-group Single-dose Study To Estimate The Effect Of Age On The Pharmacokinetics, Safety And Tolerability Of Intravenous Rivipansel (Pf-06460031)
The purpose of this study is to evaluate the effect of age on PK, safety and tolerability of IV rivipansel.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Healthy
Drug: Rivipansel
A single dose of IV rivipansel over 20 minutes.
Other Name: GMI-1070
  • Experimental: Aged 18-45 years
    A single dose of IV rivipansel over 20 minutes.
    Intervention: Drug: Rivipansel
  • Experimental: Aged 65 and older
    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 16, 2017
February 19, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy female subjects of non-childbearing potential or healthy male subjects who are between the ages of 18-45 years or 65 years of age or older.
  • Body mass index (BMI) of 17.5 to 40 kg/m2

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Pregnant females; breastfeeding female subjects; male subjects with partners currently pregnant
  • Treatment with another investigational drug within 30 days or 5 half-lives preceding the dose of study medication
  • Blood donation within 60 days prior to dosing.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02998099
B5201004
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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