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Clinical Trial Summary

The primary objective of this study is to assess the pharmacokinetics (PK) of linzagolix in subjects with varying degrees of impaired renal function compared to matched control subjects with normal renal function


Clinical Trial Description

This is a Phase 1, non-randomized, open label, single-dose study to evaluate the effect of varying degrees of impaired renal function (i.e., mild, moderate, severe Renal Impairment (RI), and End-Stage Renal Disease (ESRD) on hemodialysis) on the PK, safety, and tolerability of linzagolix and its major metabolite, KP017.

Up to 40 adult female participants will be enrolled. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03961932
Study type Interventional
Source ObsEva SA
Contact
Status Completed
Phase Phase 1
Start date May 15, 2019
Completion date January 31, 2020

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