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

G

GlycoMimetics

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Rivipansel

Study type

Interventional

Funder types

Industry

Identifiers

NCT02998099
B5201004

Details and patient eligibility

About

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

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

16 participants in 2 patient groups

Aged 18-45 years
Experimental group
Description:
A single dose of IV rivipansel over 20 minutes.
Treatment:
Drug: Rivipansel
Aged 65 and older
Experimental group
Description:
A single dose of IV rivipansel over 20 minutes.
Treatment:
Drug: Rivipansel

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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