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The primary objective of this study is to assess the pharmacokinetics (PK) of linzagolix in subjects with varying degrees of impaired hepatic function compared to match control subjects with normal hepatic function
Full description
This is a Phase 1, non-randomized, open label, single-dose study to evaluate the effect of varying degrees of impaired hepatic function (i.e., mild, moderate, and severe Hepatic Impairment (HI)) on the PK, safety, and tolerability of linzagolix and its major metabolite, KP017.
Up to 28 adult female participants will be enrolled.
Enrollment
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Inclusion and exclusion 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:
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
Key Exclusion Criteria:
Hepatic Impaired Subjects
Healthy Subjects
Primary purpose
Allocation
Interventional model
Masking
24 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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