Safety and Pharmacokinetics Study of Linzagolix in Female Subjects With Normal and Impaired Hepatic Function
Hepatic Impairment, Healthy Participants

About this trial
This is an interventional basic science trial for Hepatic Impairment focused on measuring Linzagolix, OBE2109, Hepatic Impairment, Hepatic Insufficiency, Liver Diseases, Clinical pharmacology study
Eligibility Criteria
Key Inclusion Criteria:
Hepatic Impaired Subjects
- Adult female, 18-75 years of age, inclusive, at screening
- Has a BMI ≥ 18.0 and ≤ 42.0 kg/m^2 and weight ≥ 40 kg, at screening
- Aside from HI, be sufficiently healthy for study participation based upon medical history, physical examination, vital signs, electrocardiograms (ECGs), and screening clinical laboratory profiles, as deemed by the Principal Investigator (PI) or designee
Has a score on the Child-Pugh scale at screening as follows:
- Severe HI: ≥ 10 and ≤ 15
- Moderate HI: ≥ 7 and ≤ 9
- Mild HI: ≥ 5 and ≤ 6
- Has a diagnosis of chronic (> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency with features of cirrhosis due to any etiology
Healthy Subjects
- Healthy adult female will be matched based upon age and BMI
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.
Key Exclusion Criteria:
Hepatic Impaired Subjects
- Has a clinically active Grade 3 or 4 encephalopathy
- Has fluctuating or rapidly deteriorating hepatic function within the screening period, and up to 30 days prior to Day 1, in the opinion of the PI and Sponsor
- Has history of liver or other solid organ transplant
- Had any major surgery within 4 weeks prior to dosing
- Has a surgical (e.g., hepatectomy, nephrectomy, digestive organ resection) or medical condition other than HI which might significantly alter the absorption, distribution, metabolism, or excretion of linzagolix and its metabolites, or which may jeopardize the subject's safety in case of participation in the study in the opinion of the PI or designee
Healthy Subjects
- Has any clinically significant illness, as judged by the PI or designee, within 4 weeks prior to dosing
- Has laboratory values at screening or check-in which are deemed to be clinically significant (especially derangement within liver function test), unless agreed in advance by the PI and the Sponsor
Sites / Locations
- Clinical Site
- Clinical Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Normal Hepatic Function
Mild Hepatic Impairment
Moderate Hepatic Impairment
Severe Hepatic Impairment
Healthy participants with Normal Hepatic Function
Presence of Mild Hepatic Impairment (score of 5 to 6, on the Child Pugh scale and with features of cirrhosis due to any etiology)
Presence of Moderate Hepatic Impairment (score of 7 to 9, on the Child Pugh scale and with features of cirrhosis due to any etiology)
Presence of Severe Hepatic Impairment (score of 10 to 15 on the Child Pugh scale and with features of cirrhosis due to any etiology)