A Phase 1 Study of Navlimetostat Tablet Formulations

Purpose

This study aims to compare the PK of Navlimetostat after administration of a wet-granulation tablet versus the dry-granulation tablet formulation in healthy adult female

Condition

  • Healthy Participants

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Participants must be healthy adult INOCBP female with no clinically significant findings on medical history, PE, VS, 12-lead ECGs, or clinical laboratory determinations, as assessed by the investigator. - Participants must have BMI of 18.0 to 35.0 kg/m2. - Participants must have adequate laboratory test results for renal and hepatic function, as assessed by the investigator, defined as eGFR ≥ 90 mL/min/1.73m2 using the CKD-EPI equation (screening only), and total bilirubin, ALP, GGT, AST, ALT ≤ 1.5 × ULN.

Exclusion Criteria

  • Participant must not have any significant acute or chronic medical illness (in the assessment of the investigator). - Participant must not have current or recent GI disease: Any gastrointestinal disease within 3 months of study intervention administration that could possibly affect drug absorption, distribution, metabolism, and excretion (eg, bariatric procedure, history of pancreatitis, uncontrolled nausea or vomiting) in the opinion of the investigator. - Other protocol defined inclusion/exclusion criteria applies.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment A
  • Drug: Navlimetostat
    Specified dose on specified days
    Other names:
    • BMS-986504
Experimental
Treatment B
  • Drug: Navlimetostat
    Specified dose on specified days
    Other names:
    • BMS-986504

Recruiting Locations

CenExel iResearch - Decatur
Decatur, Georgia 30030
Contact:
Kimball Johnson, Site 0002
404-537-1281

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com