PK Study of KarX, KarT, KarXT and KarX-EC in Healthy Subjects (QSC303233)
Research type
Research Study
Full title
A Phase 1, 2-Part, Open-label Study to Evaluate the Pharmacokinetics of Novel KarX (BMS-986519) and KarT (BMS-986520) Prototypes Versus the KarXT (BMS-986510) and KarX-EC (BMS-986519) Reference Following Single Doses, and to Explore the Effect of Food after Multiple Doses of Selected Prototypes in Healthy Adult Participants
IRAS ID
1011809
Contact name
Global Submission Management - CT Representative
Contact email
Sponsor organisation
Bristol-Myers Squibb Services Unlimited Company
ISRCTN Number
ISRCTN26415952
Research summary
The Sponsor is developing a new test medicine which is a new formulation of a previously tested medicine, KarXT. Currently it is marketed in the USA to treat schizophrenia in adults, but may cause further unwanted side effects in younger patients. The new form of the test medicine is a potential treatment for autism which is a neuropsychiatric condition (mental disorder affecting the nervous system including the brain) and developmental disorder (condition affecting brain development and growth) that affects how people interact with others, communicate, learn and behave.
This 2-part study will compare side effects and blood levels in healthy volunteers after giving different forms of the test medicine compared to a reference test medicine. It may also explore the effect of food on the test medicine.
This study will take place at 1 non-NHS site and aims to answer these questions.
* Does the test medicine cause any important side effects?
* How much test medicine enters the blood and how quickly does the body get rid of it?
* Does food affect blood levels of the test medicine?
* What is the taste/palatability attributes and overall acceptability of the test medicine?Each part enrols approximately 24 healthy men and women aged 18-55 years.
In Parts 1 and 2 volunteers will receive single doses of new forms of the test medicine on up to 2 and 3 occasions respectively, and a reference form of the test medicine on 1 occasion, as capsules by mouth. After this an optional Study Visit may be required in which volunteers will receive either doses of 1 form of the test medicine that they previously received or a new form twice a day for 21 days. Doses may be given with soft food for the last 9 days. They’ll stay in the clinic for up to 25 nights on up to 2 (Part 1) and 3 (Part 2) occasions, and take up to 12 (Part 1) and 13 (Part 2) weeks to finish the study.
We’ll collect blood and urine samples to do safety tests and measure the amount of test medicine.
REC name
North East - York Research Ethics Committee
REC reference
25/NE/0059
Date of REC Opinion
11 Jun 2025
REC opinion
Further Information Favourable Opinion