A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
[14C]Navlimetostat: Specified dose on specified days
Study 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
Sex
FEMALE
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Maximum observed plasma concentration (Cmax) — Up to 14 days
Time of maximum observed plasma concentration (Tmax) — Up to 14 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) — Up to 14 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) — Up to 14 days
Terminal elimination half-life (T-HALF) — Up to 14 days
Apparent total body clearance (CLT/F) — Up to 14 days
Apparent volume of distribution during the terminal phase (VZ/F) — Up to 14 days
Percent of plasma navlimetostat AUC(INF) to plasma radioactivity AUC(INF) (%AUC(INF)) — Up to 14 days
Total radioactivity (TRA) ratio of blood AUC(INF) to plasma AUC(INF) — Up to 14 days
Total amount of dose recovered in urine (UR) — Up to 14 days
Percent of administered dose recovered in urine (%UR) — Up to 14 days
Renal clearance (CLR) — Up to 14 days
TRA from UR — Up to 14 days
TRA from %UR — Up to 14 days
TRA from total amount of dose recovered in feces (FR) — Up to 14 days
TRA from percent of administered dose recovered in feces (%FR) — Up to 14 days
TRA from total amount of radioactivity recovered (Rtotal) — Up to 14 days
TRA from total percent of radioactivity recovered (%TOTAL) — Up to 14 days
TRA amount recovered of the radioactive dose in vomit, if applicable — Up to 14 days
TRA fraction of the radioactive dose in vomit, if applicable — Up to 14 days
Trial sites (2)
Facility
City
Region
Status
Local Institution - 0001
Madison
Wisconsin
Local Institution - 0002
Groningen
Provincie Groningen
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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