A Phase 1 Study to Evaluate the Mass Balance, Metabolism, Excretion, and Pharmacokinetics of [14C]Navlimetostat (BMS-986504) at Steady State in Healthy Female Participants
A Phase 1 Study to Evaluate the Mass Balance, Metabolism, Excretion, and Pharmacokinetics of [14C]Navlimetostat (BMS-986504) at Steady State in Healthy Female Participants
The purpose of this study is to evaluate the metabolism, the routes and extent of elimination, and drug levels of [14C]Navlimetostat (BMS-986504) in healthy female participants
Inclusion Criteria
Participants must have a body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive.
Participants must have a recent history (ie, last month) of a minimum of 1 bowel movement per 2 days.
Participants must be female (as assigned at birth) who is an individual not of childbearing potential (INOCBP), defined as one of the following:.
i) Surgically sterile (eg, hysterectomy, bilateral oophorectomy, or bilateral salpingectomy).
ii) Postmenopausal, defined as ≥ 12 consecutive months of amenorrhea in an individual over the age of 45 years (no other biological or physiological causes), and individuals < 55 years of age with 12 months of amenorrhea must have serum FSH levels > 40 mIU/mL at screening to confirm menopausal status.
Exclusion Criteria
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