Malignancies Multiple
Conditions
Brief summary
Assess the effects of itraconazole and rifampin on the pharmacokinetics, safety, and tolerability of BMS-986205.
Detailed description
A randomized, open-label, parallel design study in healthy participants to assess the effects of itraconazole and rifampin on the single-dose pharmacokinetics of BMS-986205. Safety and tolerability data to be collected and assessed as well.
Interventions
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index 18.0 to 32.0 kg/m2, inclusive * Must have normal renal function demonstrated by GFR, calculated by Chronic Kidney Disease Epidemiology Collaboration formula * Women must not be of childbearing potential (cannot become pregnant)
Exclusion criteria
* Any significant acute or chronic medical illness * History of glucose-6-phosphodiesterase (G6PD) deficiency * Personal or family history of cytochrome b5 reductase deficiency Other protocol defined inclusion /
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to 25 days | Measured by plasma concentration |
| AUC from time zero to time of last quantifiable concentration (AUC(0-T)) | Up to 25 days | Measured by plasma concentration |
| AUC from time zero extrapolated to infinite time (AUC(INF)) | Up to 25 days | Measured by plasma concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with physical examination findings abnormalities | Up to 25 days | — |
| Incidence of Adverse Events (AEs) | Up to 25 days | Safety and tolerability as measured by incidence of AEs |
| Number of participants with clinical laboratory abnormalities | Up to 25 days | — |
| Incidence of Serious Adverse Events (SAEs) | Up to 76 days | Safety and tolerability as measured by incidence of SAEs |
| Number of participants with electrocardiogram abnormalities | Up to 25 days | — |
Countries
United States
Outcome results
None listed