Healthy Female Participants
Conditions
Keywords
Protein arginine methyltransferase (PRMT5), Methylthioadenosine-cooperative PRMT5 inhibitor, Homozygous methylthioadenosine phosphorylase (MTAP) deletion, Mass balance study, Metabolism, Elimination, Drug absorption, Distribution, Excretion, Radiolabeled, Absorption, Excretion (ADME), Navlimtostat
Brief 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
Interventions
DRUGNavlimetostat
Specified dose on specified days
DRUG[14C]Navlimetostat
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
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 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Cmax | Up to 14 days |
| Tmax | Up to 14 days |
| Area under the plasma concentration-time curve over 1 dosing interval (AUC(TAU)) | Up to 14 days |
| Trough observed plasma concentration (Ctrough) | Up to 14 days |
| Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR_Cmax) | Up to 14 days |
| Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight (MR_AUC(TAU)) | Up to 14 days |
| Number of participants with treatment-emergent adverse events (TEAEs) | Up to 14 days |
| Number of participants with serious adverse events (SAEs) | Up to 14 days |
| Number of participants with clinically significant changes in physical examinations | Up to 14 days |
| Number of participants with clinically significant changes in vital signs | Up to 14 days |
| Number of participants with clinically significant changes in 12-lead ECGs | Up to 14 days |
| Number of participants with clinically significant changes in clinical laboratory test results | Up to 14 days |
Countries
Netherlands, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed