A Two-part Study to Investigate the Effects in Adults of Two Doses of Golexanolone in Patients With Primary Biliary Cholangitis (PBC) With Fatigue and Cognitive Dysfunction

Inclusion Criteria: * Male and female subjects age ≥ 18 years * Diagnosis of PBC based on the presence of ≥2 of 3 key disease characteristics * Clinically significant fatigue defined for the purposes of this study as a PBC-40 fatigue domain score of ≥29 at screening * Clinically significant cognitive symptoms, defined for the purposes of this study as a PBC-40 cognitive domain ≥16 at screening * Stable PBC SoC therapy (if any),for at least 3 months prior to randomisation * For all women of childbearing potential (WOCBP) a negative pregnancy test at screening and a negative urine dip-stick pregnancy test at baseline, prior to first dose of IMP * WOCBP must be willing to use a contraceptive method with a failure rate of \< 1% and agree to continue use of this method for the duration of the study and thereafter for 1 month after the last dosing of the IMP * Females of non-childbearing potential must have documented tubal ligation or hysterectomy; or be post-menopausal * Fertile male subjects must be willing to use condom and assure that their female partner will use contraceptive methods with a failure rate of \< 1% * Willing and able to give informed consent * The subject should be judged by the Investigator to be lucid and oriented to person, place, time, and situation when giving the informed consent Exclusion Criteria: * Child-Pugh class B or C cirrhosis * Clinical evidence of hepatic decompensation (e.g. current or prior HE, ascites, or variceal bleeding) * History of he…