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GnRH Antagonist
Safety and Pharmacokinetics of Linzagolix in Female Subjects With Normal and Impaired Renal Function
Phase 1
Waitlist Available
Research Sponsored by ObsEva SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose
Awards & highlights
No Placebo-Only Group
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
Eligible Conditions
- Kidney Failure
- Healthy Subjects
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Plasma PK parameter AUC0-t of linzagolix and of KP017
Plasma PK parameter T1/2 of linzagolix and of KP017
Plasma PK parameter Tmax of linzagolix and of KP017
+1 moreSecondary study objectives
Treatment emergent Adverse Events
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Experimental Treatment
Group I: Severe Renal ImpairmentExperimental Treatment1 Intervention
Presence of Severe Renal Impairment (eGFR ≤ 29 mL/min/1.73m\^2), not on hemodialysis
Group II: Normal Renal FunctionExperimental Treatment1 Intervention
Healthy participants with Normal Renal Function (estimated Glomerular Filtration Rate (eGFR) ≥ 90 mL/min/1.73m\^2)
Group III: Moderate Renal ImpairmentExperimental Treatment1 Intervention
Presence of Moderate Renal Impairment (eGFR 30-59 mL/min/1.73m\^2)
Group IV: Mild Renal ImpairmentExperimental Treatment1 Intervention
Presence of Mild Renal Impairment (eGFR 60-89 mL/min/1.73m\^2)
Group V: End-Stage Renal DiseaseExperimental Treatment1 Intervention
Presence of End-Stage Renal Disease (ESRD) requiring hemodialysis
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Linzagolix
2019
Completed Phase 1
~60
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
ObsEva SALead Sponsor
13 Previous Clinical Trials
4,348 Total Patients Enrolled