Effect of Renal or Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Intravenous Rivipansel.
Administration, Intravenous
Adult
Aged
Anemia, Sickle Cell
/ complications
Area Under Curve
Case-Control Studies
Drug Tolerance
E-Selectin
/ antagonists & inhibitors
Female
Glycolipids
/ administration & dosage
Humans
L-Selectin
/ antagonists & inhibitors
Liver Diseases
/ blood
Male
Middle Aged
Non-Randomized Controlled Trials as Topic
/ methods
P-Selectin
/ antagonists & inhibitors
Renal Insufficiency
/ blood
Safety
Selectins
GMI-1070
hemolytic anemia
selectins
Journal
Clinical pharmacology in drug development
ISSN: 2160-7648
Titre abrégé: Clin Pharmacol Drug Dev
Pays: United States
ID NLM: 101572899
Informations de publication
Date de publication:
11 2020
11 2020
Historique:
received:
12
11
2019
accepted:
26
05
2020
pubmed:
25
6
2020
medline:
28
9
2021
entrez:
25
6
2020
Statut:
ppublish
Résumé
Two studies evaluated the effects of renal and hepatic impairment on pharmacokinetics and safety of rivipansel (NCT02813798, NCT02871570). A single intravenous 840-mg rivipansel dose was administered to subjects with renal impairment or normal renal function in study 1005 and subjects with moderate hepatic impairment or normal hepatic function in study 1006. Plasma (both studies) and urine (study 1005) samples were collected for 96 hours postdose. All subjects in studies 1005 (n = 28) and 1006 (n = 16) completed all study procedures. Rivipansel exposure (AUC
Substances chimiques
E-Selectin
0
Glycolipids
0
P-Selectin
0
Selectins
0
L-Selectin
126880-86-2
rivipansel
4B115V09LB
Banques de données
ClinicalTrials.gov
['NCT02813798', 'NCT02871570']
Types de publication
Clinical Trial, Phase I
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
918-928Informations de copyright
© 2020, The American College of Clinical Pharmacology.
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