Phase I Study (QSC302318)
Research type
Research Study
Full title
A Phase 1, Open-label, Single-dose Study to Evaluate the Pharmacokinetics of Deucravacitinib (BMS-986165) Administered as Various Solid Oral Gastro-retentive Tablet Formulation Prototypes in Healthy Participants
IRAS ID
1009951
Contact name
Global Submission Management - CT N/A
Contact email
Sponsor organisation
Bristol-Myers Squibb Services Unlimited Company
Clinicaltrials.gov Identifier
Research summary
The Sponsor is developing the test medicine, deucravacitinib, as a potential treatment for Systemic Lupus Erythematosus and Sjögren’s Disease which are long-term autoimmune diseases, meaning the body’s natural defence system (immune system) attacks healthy parts of the body.
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 tablet. It may also explore the effect of food and stomach pH (using an approved acid-reducing drug, famotidine) on the test medicine.
This study will take place at 1 non-NHS site and aims to answer these questions.
* How much test medicine enters the blood and how quickly does the body get rid of it?
* Does food or stomach pH affect blood levels of the test medicine?
* How do side effects and blood levels of the test medicine compare when it’s given in different forms?Each study part plans to enrol 26 healthy men and women, 20 of whom will receive non-radiolabelled test medicine and be aged 18-55 years. The other 6 participants in each part will receive test medicine labelled with a small amount of radioactivity and undergo scintigraphy assessments on up to 4 occasions; they will be aged 30-55 years and the women must not be able to have children.
In both parts, volunteers will receive new forms of the test medicine on up to 4 occasions and the approved form of the test medicine on 1 occasion, as tablets by mouth, with or without food. In addition, the test medicine may be given with an approved medicine that reduces stomach pH on up to 1 occasion. They’ll stay in the clinic for up to 19 nights on up to 4 occasions, and take up to 22 (Part A) and 16 (Part B) weeks to finish the study.
Blood and urine samples are collected to do safety tests and measure the amount of test medicine. Scintigraphy assessments are performed to assess the time the dose is held in the stomach and how long it takes for the tablet to dissolve.
REC name
Wales REC 2
REC reference
24/WA/0170
Date of REC Opinion
24 Sep 2024
REC opinion
Further Information Favourable Opinion