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NCT07777133
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Conditions: Healthy Female Participants
Sex: Female
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 6
Sponsor: Bristol-Myers Squibb
Location: Local Institution - 0001 Madison Wisconsin
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 Criteria
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
* Participants must not have any significant acute or chronic medical illness.
* Participants must not have current or recent gastrointestinal disease.
* Participants must not have a history of prolonged bleeding or excessive bruising.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Source: ClinicalTrials.gov (NCT07777133). StuddyBuddy aggregates publicly available trial information.