How Navlimetostat is processed in healthy women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional study uses a radiolabeled form of Navlimetostat to map its metabolism, routes of elimination, and overall drug exposure in healthy female participants. The study collects pharmacokinetic data to quantify drug levels and balance of metabolites. Recruitment focuses on women who are not at risk of pregnancy and meet strict health criteria to minimize confounding factors. The study sites include a Madison, Wisconsin center and a Groningen, Netherlands site, with Bristol-Myers Squibb as lead sponsor.

Why it matters

Who can join: the full rules

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.

Where it's running

• ICON Netherlands - Groningen
  Groningen, Provincie Groningen, Netherlands Recruiting
• Local Institution - 0002
  Madison, Wisconsin, United States Not yet recruiting

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.