A Study of TAK-781 in Healthy Volunteers and in Participants With Non-Cirrhotic Primary Sclerosing Cholangitis (PSC)
Sponsored by Takeda
About this trial
Last updated a month ago
Study ID
TAK-781-1001
Status
Recruiting
Type
Interventional
Phase
Phase 1
Placebo
Yes
Accepting
18 to 68 Years
All
Trial Timing
Started 3 months ago
What is this trial about?
The main aim of this study is to see if the drug TAK-781 is safe for healthy volunteers
and for participants with PSC. The study will also look at how well participants can
tolerate TAK-781. In addition, the study will check how the body absorbs, uses, and gets
rid of TAK-781 (Pharmacokinetics [PK]), how the drug affects the body (Pharmacodynamics
[PD]), and how the body's immune system reacts to TAK-781 (Immunogenicity).
The study consists of two phases (Phase 1a and 1b). Phase 1a includes two parts: Part 1
(Single Ascending Dose [SAD]) and Part 2 (Multiple Ascending Dose [MAD]). In Part 1,
healthy participants will receive either single dose of TAK-781 or a placebo. A placebo
looks the same as TAK-781 but has no medicine in it. In Part 2, healthy participants will
receive multiple doses of TAK-781 or a placebo. In Phase 1b (Part 3), participants with
large duct, non-cirrhotic PSC will receive a single dose of TAK-781.
Participants will be in the study for about 36 weeks.
What are the participation requirements?
Inclusion Criteria
Must be women and men aged 18 to 68 years.
Must be diagnosed with large-duct, non-cirrhotic Primary Sclerosing Cholangitis (PSC), (Phase 1b). This is a disease in which the tubes that carry bile from the liver become inflamed and scarred. This causes injury to the liver, but participants in this study should not yet have severe scarring (cirrhosis) or advanced liver failure requiring a transplant in the near future.
Exclusion Criteria
Cannot have strong or many allergies (Phase 1a).
Cannot have history of unusual bleeding or any problems with how their blood clots (Phase 1a).
Cannot have their gallbladder removed.
Additional entry criteria will be discussed with the study physician.
Locations
Location
Status
Recruiting
For more information, view the full study details:
NCT07229911