A Phase 1 Study of Navlimetostat Tablet Formulations

Official title

A Phase 1, Open-label, Randomized, 2-Treatment, 2-Period, Crossover Study to Assess the Bioequivalence of Navlimetostat Wet-Granulation Tablet Versus the Dry-Granulation Tablet Formulation in Healthy Adult Female (as Assigned at Birth) Participants Who Are Individuals Not of Childbearing Potential

Overview

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

Interventions

• Drug Navlimetostat
  Specified dose on specified days

Primary outcome measures

• Maximum Plasma Concentration (Cmax) [Time frame: Up to Day 17]
• Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] [Time frame: Up to Day 17]
• Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] [Time frame: Up to Day 17]
• Number of participants with Adverse Events (AE) [Time frame: Up to approximately day 37]
• Number of participants with Serious Adverse Events (AE) [Time frame: Up to approximately day 37]
• Number of participants with clinically significant changes in Physical Examinations (PE) [Time frame: Up to Day 17]
• Number of participants with clinically significant changes in vital signs (VS) [Time frame: Up to Day 17]
• Number of participants with clinically significant changes in 12-lead ECGs [Time frame: Up to Day 17]
• Number of participants with clinically significant changes in laboratory tests results [Time frame: Up to Day 17]

Secondary outcome measures (5)

• Time of maximum observed drug concentration (Tmax) [Time frame: Up to Day 17]
• Terminal elimination half-life (T-HALF) [Time frame: Up to Day 17]
• Apparent total body clearance (CLT/F) [Time frame: Up to Day 17]
• Apparent volume of distribution during the terminal phase (Vz/F) [Time frame: Up to Day 17]
• Mean residence time (MRT) [Time frame: Up to Day 17]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 4 centers

• CenExel iResearch - Decatur — Decatur
• Local Institution - 0003 — Decatur
• Local Institution - 0001 — Austin
• Local Institution - 0004 — Austin

Identifiers

NCT: NCT07544628 · CA240-0014

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗