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
Bristol-Myers Squibb
Summary
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
Eligibility
- Age range
- 18–55 years
- Sex
- Female
- Healthy volunteers
- Yes
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 physiologica…
Interventions
- DrugNavlimetostat
Specified dose on specified days
- Drug[14C]Navlimetostat
Specified dose on specified days
Locations (2)
- Local Institution - 0001Madison, Wisconsin
- Local Institution - 0002Groningen, Provincie Groningen