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

NCT02998099 | Completed Phase 1 FDA Drug

• 1 other identifier: B5201004
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Healthy Volunteers; Rivipansel

Outcome Measures

Primary Outcomes (2)

• 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.

  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

• Clearance (CL)

  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 (9)

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

  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.

• Maximum plasma concentration

  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.

• Mean elimination half-life

  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.

• Volume of distribution at steady state

  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.

• Physical examination

  Baseline up to 72 hours

Other Outcomes (1)

• Banked Biospecimen

  Day 0

Study Arms (2)

Aged 18-45 years

EXPERIMENTAL

A single dose of IV rivipansel over 20 minutes.

Drug: Rivipansel

Aged 65 and older

EXPERIMENTAL

A single dose of IV rivipansel over 20 minutes.

Drug: Rivipansel

Interventions

Rivipansel DRUG

A single dose of IV rivipansel over 20 minutes.

Also known as: GMI-1070

Aged 18-45 years; Aged 65 and older

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlycoMimetics Incorporated: lead

Study Sites (1)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

MeSH Terms

Interventions

rivipansel

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

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: December 16, 2016
• First Posted: December 20, 2016
• Study Start: January 1, 2017
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2017
• Last Updated: June 18, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)