Healthy Participants
Conditions
Brief summary
The purpose of this study is to assess the effect of food on the drug levels of Admilparant
Interventions
DRUGAdmilparant
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants must have a body mass index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening. * Participants must have a body weight of ≥ 50 kg for males and ≥ 45 kg for females at screening.
Exclusion criteria
* Participants must not have any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study. * Participants must not have had any previous exposure to Admilparant. * Participants must not have a history of any severe drug allergy or drug reaction (such as anaphylaxis or hepatotoxicity). * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration (Cmax) | Up to 13 days |
| Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) | Up to 13 days |
| Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | Up to 13 days |
Secondary
| Measure | Time frame |
|---|---|
| Apparent volume of distribution (Vz/F) | Up to 13 days |
| Number of participants with adverse events (AEs) | Up to 13 days |
| Number of participants with a change in clinical laboratory values | Up to 13 days |
| Time of maximum observed plasma concentration (Tmax) | Up to 13 days |
| Number of participants with a change in physical examination results | Up to 13 days |
| Number of participants with a change in 12-lead electrocardiogram (ECG) results | Up to 13 days |
| Number of participants with a change in vital sign measurements | Up to 13 days |
| Terminal half-life (T-HALF) | Up to 13 days |
| Apparent total body clearance (CLT/F) | Up to 13 days |
Countries
United States
Outcome results
None listed