Healthy Volunteers
Conditions
Brief summary
This is a Phase 1, open-label, randomized study in healthy participants to evaluate the absorption of a BMS-986205 tablet into the bloodstream compared to a reference tablet. Eligible participants will be randomly assigned to 1 of 2 treatment sequences and will receive a single, oral dose of BMS-986205 twice over 22 days. Participants must remain at the clinical facility for the duration of the study.
Interventions
DRUGBMS-986205 reference tablet
Single, 100 mg oral dose.
DRUGBMS-986205 tablet with free base
Single, 100 mg oral dose.
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Signed, written informed consent. * Healthy male and female participants (not of childbearing potential), determined by medical history, physical examination, electrocardiograms (ECGs) and clinical laboratory tests. * Normal renal (kidney) function. * Body Mass Index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive. * Women must have documented proof they are not of childbearing potential. * Males who are sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment and 110 days after the last dose of BMS-986205. In addition, male participants must be willing to refrain from sperm donation during this time.
Exclusion criteria
* Women of childbearing potential or breastfeeding. * Active tuberculosis (TB) requiring treatment or documented latent TB within the previous 3 years. Also excluded are participants with evidence of a past TB infection without documented adequate therapy. * History of pulmonary, renal, or liver disease; or of cardiac arrhythmias. * Recent (within 6 months of study drug administration) history of smoking or current smokers. This includes participants using electronic cigarettes or nicotine-containing products such as tobacco for chewing, nicotine patches, nicotine lozenges or nicotine gum. * Donation of blood to a blood bank or in a clinical study (except screening or follow-up visit) within 4 weeks of study drug administration (within 2 weeks for plasma only). Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of BMS-986205 tablet with free base compared to reference tablet. | Up to Day 22 | Measured by plasma concentration. |
| Area under the plasma concentration time curve from time zero to 168 hours after dosing (AUC[0-168]) of BMS-986205 tablet with free base compared to reference tablet. | Up to Day 22 | Measured by plasma concentration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events (AEs) leading to discontinuation. | Up to Day 22 | Safety and tolerability as measured by incidence of AEs leading to discontinuation. |
| Number of participants with vital sign abnormalities. | Up to Day 22 | — |
| Incidence of non-serious Adverse Events (AEs). | Up to Day 22 | Safety and tolerability as measured by incidence of non-serious AEs. |
| Number of participants with clinical laboratory abnormalities. | Up to Day 22 | — |
| Number of participants with physical examination abnormalities. | Up to Day 22 | — |
| Number of participants with electrocardiogram (ECG) abnormalities. | Up to Day 22 | — |
| Incidence of Serious Adverse Events (SAEs). | Up to Day 22 | Safety and tolerability as measured by incidence of SAEs. |
Countries
United States
Outcome results
None listed