The aim of these studies was to assess the safety and pharmacokinetics of 
elagolix, an oral nonpeptide gonadotropin-releasing hormone antagonist following 
oral administration in women with renal or hepatic impairment. Two phase 1 
studies were conducted in adult women with normal renal function versus renal 
impairment (reduced study), and normal hepatic function versus hepatic 
impairment (full study design). All women received a single dose of elagolix 200 
mg (renal) or 150 mg (hepatic). Intensive pharmacokinetic blood samples were 
collected. Elagolix exposures were comparable in women with normal renal 
function and those with moderate/severe renal impairment or end-stage renal 
disease. Elagolix exposures also appeared to be similar in women with normal 
hepatic function and women with mild hepatic impairment. Elagolix area under the 
curve in women with moderate hepatic impairment and with severe hepatic 
impairment was approximately 3-fold and 7-fold higher than in women with normal 
hepatic function. The adverse event incidence was low, with the main events 
being mild nausea and headache. No dosage adjustment was needed in women with 
renal impairment or women with mild hepatic impairment. Although an elagolix 
dose of 150 mg once daily may be used in women with moderate hepatic impairment 
for up to 6 months, this elagolix dose should not be used in women with severe 
hepatic impairment.