Evaluating drug levels of a new formulation of Deucravacitinib in healthy participants
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
This study is testing a new version of a medication called Deucravacitinib in healthy volunteers to see how well it stays in the stomach and how the body absorbs it.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Drugs / interventions | deucravacitinib |
| Locations | 2 sites (Nottingham, Nottinghamshire and 1 other locations) |
| Trial ID | NCT06566768 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the drug levels of various gastro-retentive formulations of Deucravacitinib (BMS-986165) in healthy volunteers. The focus is on understanding how these formulations can prolong the retention time of the drug in the stomach, which may enhance its effectiveness. Participants will receive a single dose of the drug, and their responses will be monitored to gather data on absorption and pharmacokinetics. The study is designed to ensure that only healthy individuals within a specific BMI range are included.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy males and females with a BMI between 18.0 and 32.0 kg/m² and a body weight of at least 50 kg.
Not a fit: Patients with significant acute or chronic medical illnesses or recent gastrointestinal diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved formulations of Deucravacitinib that enhance its therapeutic effects.
How similar studies have performed: While this specific approach is novel, similar studies evaluating gastro-retentive formulations have shown promise in enhancing drug delivery.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy males and healthy females according to the assessment of the Investigator. * Body mass index of 18.0 kg/m\^2 through 32.0 kg/m\^2, inclusive, and body weight ≥ 50 kg. Exclusion Criteria: * Any significant acute or chronic medical illness. * Current or recent (within 3 months of first dose) gastrointestinal (GI) disease that could possibly affect drug absorption, distribution, metabolism, and excretion. * History of any significant drug allergy. * Other protocol-defined Inclusion/Exclusion criteria apply.
Where this trial is running
Nottingham, Nottinghamshire and 1 other locations
- Local Institution - 0002 — Nottingham, Nottinghamshire, United Kingdom (Withdrawn)
- Quotient Sciences — Nottingham, Nottinghamshire, United Kingdom (Recruiting)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.