Document Detail


Metabolism and disposition of a gamma-aminobutyric acid type A receptor partial agonist in humans.
MedLine Citation:
PMID:  18180269     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The metabolism and disposition of N-[3-fluoro-4-[2-(propylamino)ethoxy]phenyl]-4,5,6,7-tetrahydro-4-oxo-1H-indole-3-carboxamide (1), a potent subtype-selective partial agonist at the gamma-aminobutyric acid type A receptor complex, were elucidated in humans following a p.o. dose of N-[3-fluoro-4-[2-(propylamino)ethoxy]phenyl]-4,5,6,7-tetrahydro-4-oxo-1H-[3-(14)C]indole-3-carboxamide monomethane-sulfonate ([(14)C]1). Overall, 1 was well tolerated, with approximately twice as much radioactivity excreted in feces (64.8 +/- 13.3%) as in urine (28.4 +/- 8.8%). Across subjects, the oral clearance of 1 was composed of both renal (10%) and metabolic (< or =90%) components, with the biotransformation of 1 happening predominately via oxidative deamination to either 2-fluoro-4-[(4-oxo-4,5,6,7-tetrahydro-1H-indole-3-carbonyl)-amino]-phenoxy acetic acid (2) or 4-oxo-4,5,6,7-tetrahydro-1H-indole-3-carboxylic acid [3-fluoro-4-(2-hydroxy-ethoxy)-phenyl]-amide (3) and minimally by aliphatic hydroxylation and carbamate formation. Active renal secretion of 1 was observed as its unbound renal clearance was 6-fold greater than the glomerular filtration rate. Experiments using human hepatic in vitro systems were undertaken to better understand the enzyme(s) involved in the clinically observed oxidative biotransformation pathways. N-Dealkylation of 1, the principal metabolic route observed in vivo, was found to be predominately monoamine oxidase-B-mediated with the resulting putative aldehyde intermediate undergoing subsequent oxidation to 2 or reduction to 3.
Authors:
Christopher L Shaffer; Mithat Gunduz; Alfin D Vaz; Karthik Venkatakrishnan; Aaron H Burstein
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Publication Detail:
Type:  Comparative Study; Journal Article     Date:  2008-01-07
Journal Detail:
Title:  Drug metabolism and disposition: the biological fate of chemicals     Volume:  36     ISSN:  1521-009X     ISO Abbreviation:  Drug Metab. Dispos.     Publication Date:  2008 Apr 
Date Detail:
Created Date:  2008-03-24     Completed Date:  2008-06-23     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9421550     Medline TA:  Drug Metab Dispos     Country:  United States    
Other Details:
Languages:  eng     Pagination:  655-62     Citation Subset:  IM    
Affiliation:
Pharmacokinetics, Dynamics and Metabolism, Pfizer Global Research and Development, Groton/New London Laboratories, Pfizer Inc., Eastern Point Road, MS 8220-4186, Groton, CT 06340, USA. christopher.l.shaffer@pfizer.com
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
GABA Agonists / chemistry*,  metabolism*
Humans
Male
Metabolic Networks and Pathways / physiology
Microsomes, Liver / metabolism
Middle Aged
Receptors, GABA-A / agonists*,  metabolism*
Tissue Distribution / physiology
Chemical
Reg. No./Substance:
0/GABA Agonists; 0/Receptors, GABA-A

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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