26 Participants Needed

Deucravacitinib Formulations for Healthy Subjects

Recruiting at 1 trial location
BC
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Overseen ByFirst line of the email MUST contain the NCT# and Site#
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Bristol-Myers Squibb
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial is for healthy subjects, it's likely that participants should not be on any regular medications.

What makes the drug Deucravacitinib unique compared to other treatments?

Deucravacitinib is unique because it is a selective TYK2 inhibitor, which means it targets a specific part of the immune system involved in inflammation, potentially offering a more targeted approach with fewer side effects compared to broader JAK inhibitors used for similar conditions.12345

What is the purpose of this trial?

The purpose of this study is to evaluate the bioequivalence between immediate release tablets and minitablets of Deucravacitinib (BMS-986165), and the effect of food and pH on the drug levels of the minitablets in healthy adults.

Research Team

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for healthy adults who can safely take Deucravacitinib, a medication under study. Participants must meet certain health standards but specific inclusion and exclusion criteria are not listed.

Inclusion Criteria

My BMI is between 18 and 32, and I weigh at least 50 kg (110 lb).
Participants must be healthy as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory determinations in the opinion of the investigator
I am willing and able to follow all study requirements.

Exclusion Criteria

Other protocol-defined Inclusion/Exclusion criteria apply
I do not have any serious health issues that could risk my safety in the study.
My organs function properly, and my medical tests are within normal ranges.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of Deucravacitinib in various formulations to assess bioequivalence and the effect of food and pH

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including physical examinations

3 weeks
Up to day 21

Treatment Details

Interventions

  • Deucravacitinib
Trial Overview The study is testing if small minitablets of Deucravacitinib have the same body response as regular tablets. It also looks at how food and stomach acidity affect the drug's levels in the body.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: BMS-986165 Formulation 2 + FedExperimental Treatment1 Intervention
Group II: BMS-986165 Formulation 2 + FamotidineExperimental Treatment2 Interventions
Group III: BMS-986165 Formulation 2Experimental Treatment1 Intervention
Group IV: BMS-986165 Formulation 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Findings from Research

The study successfully established a validated Level A in-vitro in-vivo correlation (IVIVC) for the tofacitinib extrudable core system (ECS) osmotic tablet platform, indicating that in vitro dissolution can reliably predict in vivo absorption.
The IVIVC models showed excellent prediction accuracy, meeting FDA criteria with maximum prediction errors of 4.6% for individual data and 3.9% for average data, demonstrating the efficacy of the ECS platform in delivering tofacitinib for rheumatoid arthritis treatment.
Development and validation of a Level A in-vitro in-vivo correlation for tofacitinib modified-release tablets using extrudable core system osmotic delivery technology.Kushner, J., Lamba, M., Stock, T., et al.[2021]
The study found that the two formulations of dovitinib (CSF and FMI) had similar systemic exposure, indicating that both can be used interchangeably in patients with advanced solid tumors.
Food intake did not significantly affect the absorption of dovitinib, allowing patients to take the medication with or without meals, which enhances convenience and adherence.
The effect of formulation and food consumption on the bioavailability of dovitinib (TKI258) in patients with advanced solid tumors.Sharma, S., Britten, CD., Mortimer, J., et al.[2014]
The study found that both low C-form and high C-form crystalline versions of lenvatinib capsules showed bioequivalence to the standard reference formulation, indicating similar drug absorption and effectiveness in healthy volunteers (59 subjects).
The safety profile was comparable across all formulations, with treatment-emergent adverse events occurring in 20-24% of participants, although one serious adverse event (spontaneous abortion) was reported in the low C-form group.
A randomized, three-treatment, three-period, six-sequence-crossover, single-center, bioequivalence study to evaluate the impact of different 10-mg crystalline forms on the pharmacokinetics of lenvatinib in healthy volunteers.Lee, L., D'Angelo, P., Verbel, D., et al.[2015]

References

Development and validation of a Level A in-vitro in-vivo correlation for tofacitinib modified-release tablets using extrudable core system osmotic delivery technology. [2021]
The effect of formulation and food consumption on the bioavailability of dovitinib (TKI258) in patients with advanced solid tumors. [2014]
A randomized, three-treatment, three-period, six-sequence-crossover, single-center, bioequivalence study to evaluate the impact of different 10-mg crystalline forms on the pharmacokinetics of lenvatinib in healthy volunteers. [2015]
Utility of Modeling and Simulation Approach to Support the Clinical Relevance of Dissolution Specifications: a Case Study from Upadacitinib Development. [2022]
Local Treatment of Non-small Cell Lung Cancer with a Spray-Dried Bevacizumab Formulation. [2022]
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