A study to assess the safety, tolerability and pharmacokinetics of tideglusib in subjects with hepatic impairment compared to healthy subjects.

End 9 Apr 2025 · Status Ended · 1 EU/EEA countries · 2 sites · Protocol AMO-02-MD-1-001

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other

Status Ended

Participants planned 48

Countries 1

Sites 2

Hepatic impairment

Key facts

Sponsor: Amo Pharma Limited
Participant type: Patients, Healthy volunteers
Age range: 18-64 years
Gender: Male and Female
Therapeutic area: Diseases [C] - Nervous System Diseases [C10], Diseases [C] - Musculoskeletal Diseases [C05]
Trial duration: completed 9 Apr 2025
Decision date (initial): 2024-10-09
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

External identifiers

EU CT number: 2024-516774-30-00
EudraCT number: 2022-003796-42

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Hepatic impairment

Version	Level	Code	Term	System organ class
22.1	LLT	10052254	Hepatic impairment	10019805
26.0	LLT	10088820	Clinical trial healthy volunteer	100000004848

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amo Pharma Limited

Sponsor organisation: Amo Pharma Limited
Address: 1 Park Row
City: Leeds
Postcode: LS1 5AB
Country: United Kingdom

Scientific contact point

Organisation: Amo Pharma Limited
Contact name: Dr Mike Snape

Public contact point

Organisation: Amo Pharma Limited
Contact name: Dr Mike Snape

Locations

1 EU/EEA country · 2 investigational sites

By country

Country	MS status	Planned subjects	Sites
Bulgaria	Ended	48	2
Rest of world	—	0	—

Investigational sites

Bulgaria

2 sites · Ended

Medical Center Comac Medical Ltd.

Clinical Research Unit, Ulitsa Sveti Georgi Sofiyski 3, 1606, Sofia