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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

18-75 Years
18 to 68 Years
All
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?

Yes

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.
No

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