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Completed

NCT Number: NCT02998099

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

The purpose of this study is to evaluate the effect of age on PK, safety and tolerability of IV rivipansel.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rivipansel

Drug

A single dose of IV rivipansel over 20 minutes.

Other names: GMI-1070

Primary outcomes

  1. Area under the plasma concentration-time profile from time 0 extrapolated to infinite time or area under the plasma concentration-time from time 0 to time of the last quantifiable concentration as data permit.

    Time frame: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48 and 72 hours following single dose administration of IV rivipansel

  2. Clearance (CL)

    Time frame: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48 and 72 hours following single dose administration of rivipansel.

Secondary outcomes

  1. Area under the plasma concentration-time profile from time 0 to time of last quantifiable concentration

    Time frame: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48 and 72 hours following single dose administration of rivipansel.

  2. Maximum plasma concentration

    Time frame: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48 and 72 hours following single dose administration of rivipansel.

  3. Mean elimination half-life

    Time frame: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48 and 72 hours following single dose administration of rivipansel.

  4. Volume of distribution at steady state

    Time frame: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48 and 72 hours following single dose administration of rivipansel.

  5. Physical examination

    Time frame: Baseline up to 72 hours

  6. Assessment of adverse events

    Time frame: Baseline up to 28 days

  7. Assessment of 12-lead electrocardiogram

    Time frame: Baseline up to 72 hours

  8. Assessment of vital signs

    Time frame: Baseline up to 72 hours

  9. Assessment of laboratory tests

    Time frame: Baseline up to 72 hours

Other outcomes

  1. Banked Biospecimen

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

GlycoMimetics Incorporated

Industry

Registry information

Official study title

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)

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 20, 2016
Registry last updated
Jun 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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