Navlimetostat
DrugSpecified dose on specified days
Other names: BMS-986504
Not yet recruiting
NCT Number: 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
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
Not yet recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year–55 year
Sex eligibility
Female
Study type
Interventional
Phase
Phase 1
Primary location
Local Institution - 0002, Groningen, Provincie Groningen, Netherlands
Loading trial locations.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
[14C]Navlimetostat
DrugSpecified dose on specified days
Other names: BMS-986504
Primary outcomes
-
Maximum observed plasma concentration (Cmax)
Time frame: Up to 14 days
-
Time of maximum observed plasma concentration (Tmax)
Time frame: 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))
Time frame: Up to 14 days
-
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to 14 days
-
Terminal elimination half-life (T-HALF)
Time frame: Up to 14 days
-
Apparent total body clearance (CLT/F)
Time frame: Up to 14 days
-
Apparent volume of distribution during the terminal phase (VZ/F)
Time frame: Up to 14 days
-
Percent of plasma navlimetostat AUC(INF) to plasma radioactivity AUC(INF) (%AUC(INF))
Time frame: Up to 14 days
-
Total radioactivity (TRA) ratio of blood AUC(INF) to plasma AUC(INF)
Time frame: Up to 14 days
-
Total amount of dose recovered in urine (UR)
Time frame: Up to 14 days
-
Percent of administered dose recovered in urine (%UR)
Time frame: Up to 14 days
-
Renal clearance (CLR)
Time frame: Up to 14 days
-
TRA from UR
Time frame: Up to 14 days
-
TRA from %UR
Time frame: Up to 14 days
-
TRA from total amount of dose recovered in feces (FR)
Time frame: Up to 14 days
-
TRA from percent of administered dose recovered in feces (%FR)
Time frame: Up to 14 days
-
TRA from total amount of radioactivity recovered (Rtotal)
Time frame: Up to 14 days
-
TRA from total percent of radioactivity recovered (%TOTAL)
Time frame: Up to 14 days
-
TRA amount recovered of the radioactive dose in vomit, if applicable
Time frame: Up to 14 days
-
TRA fraction of the radioactive dose in vomit, if applicable
Time frame: Up to 14 days
Secondary outcomes
-
Cmax
Time frame: Up to 14 days
-
Tmax
Time frame: Up to 14 days
-
Area under the plasma concentration-time curve over 1 dosing interval (AUC(TAU))
Time frame: Up to 14 days
-
Trough observed plasma concentration (Ctrough)
Time frame: Up to 14 days
-
Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR_Cmax)
Time frame: Up to 14 days
-
Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight (MR_AUC(TAU))
Time frame: Up to 14 days
-
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: Up to 14 days
-
Number of participants with serious adverse events (SAEs)
Time frame: Up to 14 days
-
Number of participants with clinically significant changes in physical examinations
Time frame: Up to 14 days
-
Number of participants with clinically significant changes in vital signs
Time frame: Up to 14 days
-
Number of participants with clinically significant changes in 12-lead ECGs
Time frame: Up to 14 days
-
Number of participants with clinically significant changes in clinical laboratory test results
Time frame: Up to 14 days
Study contacts
Contact information is provided by the study sponsor or research team.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
First line of the email MUST contain NCT # and Site #.
CONTACT
Sponsors and collaborators
Lead sponsor
Bristol-Myers Squibb
Industry
Registry information
Official study title
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
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Aug 20, 2026
- Registry last updated
- Aug 20, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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