NCT03961932

Safety and Pharmacokinetics of Linzagolix in Female Subjects With Normal and Impaired Renal Function

Evaluation of the Safety and Pharmacokinetics of a Single Dose of Linzagolix in Female Subjects With Normal and Impaired Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: ObsEva SA · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Renal Impairment
• Healthy Participants

Interventions

Type	Name	Description
DRUG	Linzagolix	A single dose of 200 mg linzagolix (2 tablets of 100 mg) will be administered orally under fasting conditions

Timeline

• Start date: 2019-05-15
• Primary completion: 2020-01-22
• Completion: 2020-01-31
• First posted: 2019-05-23
• Last updated: 2020-03-05

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study