GOLEXANOLONE ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
93原発性胆汁性胆管炎1

93. 原発性胆汁性胆管炎


臨床試験数 : 298 薬物数 : 252 - (DrugBank : 59) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 115
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2022-000422-16-HU
(EUCTR)
26/07/202224/05/2022A two-part study to investigate the effects in adults of two doses of a new drug called golexanolone in patients with primary biliary cholangitis with fatigue and cognitive dysfunctionA randomised, double-blind, placebo-controlled, two-part study to evaluate the pharmacokinetics, safety and tolerability, and preliminary efficacy of two dose levels of golexanolone in subjects with primary biliary cholangitis, fatigue, and cognitive dysfunction. Primary biliary cholangitis (PBC)
MedDRA version: 20.0;Level: SOC;Classification code 10019805;Term: Hepatobiliary disorders;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Golexanolone
Product Code: GR3027
INN or Proposed INN: GOLEXANOLONE
Umecrine Cognition ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
101Phase 1;Phase 2Serbia;Hungary;Germany;United Kingdom;Italy