Food Effect Study in Healthy Volunteers

A Phase 1 Open-Label, Randomized, Crossover Food Effect and Formulation Assessment for Icovamenib Capsule in Healthy Volunteers

A phase 1 open-label, randomized, crossover food effect and formulation assessment for icovamenib capsule in healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: Icovamenib; Drug: Icovamenib HPMC

Detailed Description

This is a phase 1, open-label, randomized, single dose, up to 7-way crossover study. It is planned to enroll 60 healthy male and female subjects. Subjects will be randomized to receive one of 5 sequences, with N=12 per sequence. Subjects will be dosed in a single residency period. This study is designed to evaluate the effect of meal time and fat content of food on the PK and safety of the icovamenib capsule and the icovamenib hydroxypropyl methylcellulose (HPMC) capsule formulation.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33126
      • Quotient Sciences - Miami, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Informed Consent and Compliance

1. Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures.
2. Must be willing and able to comply with all study requirements. Baseline Characteristics
3. Healthy males or non-pregnant, non-lactating healthy females.
4. Body mass index (BMI) of 18.0 to 27.0 kg/m2 as measured at screening.
5. HbA1c ≤ 5.6%.
6. Fasting glucose ≤ 99 mg/dL.

Exclusion Criteria:

Medical/Surgical History and Mental Health

1. Mean QTcF interval greater than 440 msec on triplicate ECGs. Use of prescription or over-the-counter (OTC) medications known to significantly prolong the QT or QTcF interval.
2. History of hypertension or untreated hypertension (systolic blood pressure (BP) >140 mmHg and/or diastolic BP >90 mmHg).
3. Known self or family history (first-degree relative) of multiple endocrine neoplasia Type 1.

4. History of stomach or intestinal surgery or resection (except appendectomy, hernia and/or cholecystectomy).

   Diagnostic assessments.

5. Clinically significant abnormal clinical chemistry, hematology, coagulation or urinalysis as judged by the investigator.
6. History or evidence of hepatitis C virus (HCV), or hepatitis B virus (HBV) infection or human immunodeficiency virus (HIV) at screening.
7. Estimated creatinine clearance (CLcr) of <90 mL/min.
8. AST, ALT or bilirubin > ULN at screening.
9. Prior Study Participation.
10. Subjects who have received any IMP in a clinical research study within 5 half-lives or within 30 days prior to first dose.
11. Prior and Concomitant Medication.
12. Subjects who are taking, or have taken, any prescribed or OTC drug or herbal remedies (other than HRT/hormonal contraception and up to 4 g per day acetaminophen) in the 14 days before first study medication administration.
13. Currently dieting (formal weight loss program) and/or are currently using or have used within 2 months of screening any drugs for weight management.
14. Received prior menin inhibitor treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Regimen A; A - icovamenib capsule 100mg in fasted state	Drug: Icovamenib; Investigational Product; Other Names: BMF-219
Experimental: Regimen B; B - icovamenib capsule 100mg in the fed state (0.5 h after initiation of low-fat breakfast)	Drug: Icovamenib; Investigational Product; Other Names: BMF-219
Experimental: Regimen C; C - icovamenib capsule 100mg in the fed state (1 h after initiation of a low-fat breakfast)	Drug: Icovamenib; Investigational Product; Other Names: BMF-219
Experimental: Regimen D; D - icovamenib capsule 100mg in the fed state (0.5 h after initiation of a high-fat breakfast)	Drug: Icovamenib; Investigational Product; Other Names: BMF-219
Experimental: Regimen E; E - icovamenib capsule 100mg in the fed state (1 h after initiation of a high-fat breakfast)	Drug: Icovamenib; Investigational Product; Other Names: BMF-219
Experimental: Regimen F; F - icovamenib HPMC capsule 100mg in the fed state (0.5 h after initiation of a high-fat breakfast)	Drug: Icovamenib HPMC; Investigational Product; Other Names: BMF-219 HPMC
Experimental: Regimen G; G - icovamenib HPMC capsule 100mg in the fed state (1h after initiation of a high-fat breakfast)	Drug: Icovamenib HPMC; Investigational Product; Other Names: BMF-219 HPMC
Experimental: Regimen H; H - icovamenib HPMC capsule 100mg in the fed state (0.5 h after initiation of a low-fat breakfast)	Drug: Icovamenib HPMC; Investigational Product; Other Names: BMF-219 HPMC
Experimental: Regimen I; I - icovamenib HPMC capsule 100mg in the fed state (1 h after initiation of a low-fat breakfast)	Drug: Icovamenib HPMC; Investigational Product; Other Names: BMF-219 HPMC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate food effect and PK profile of icovamenib capsule formulation in fed and fasted states	Tmax	Every other day for a max of 2 weeks
Evaluate food effect and PK profile of icovamenib capsule formulation in fed and fasted states	Cmax	Every other day for a max of 2 weeks
Evaluate food effect and PK profile of icovamenib capsule formulation in fed and fasted states	AUC (0-last)	Every other day for a max of 2 weeks
Evaluate food effect and PK profile of icovamenib capsule formulation in fed and fasted states	AUC (0-inf)	Every other day for a max of 2 weeks
Evaluate food effect and PK profile of icovamenib capsule formulation in fed and fasted states	T1/2	Every other day for a max of 2 weeks
Evaluate food effect and PK profile of icovamenib capsule formulation in fed and fasted states	MRT (0-inf)	Every other day for a max of 2 weeks
Evaluate food effect and PK profile of icovamenib capsule formulation in fed and fasted states	Tlag	Time Frame: Every other day for a max of 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate food effect and PK profile of icovamenib HPMC capsule formulation in fed states	Tmax	Every other day for a max of 2 weeks
Evaluate food effect and PK profile of icovamenib HPMC capsule formulation in fed states	Cmax	Every other day for a max of 2 weeks
Evaluate food effect and PK profile of icovamenib HPMC capsule formulation in fed states	AUC (0-last)	Every other day for a max of 2 weeks
Evaluate food effect and PK profile of icovamenib HPMC capsule formulation in fed states	AUC (0-inf)	Every other day for a max of 2 weeks
Evaluate food effect and PK profile of icovamenib HPMC capsule formulation in fed states	T1/2	Every other day for a max of 2 weeks
Evaluate food effect and PK profile of icovamenib HPMC capsule formulation in fed states	MRT(0-inf)	Every other day for a max of 2 weeks
Evaluate food effect and PK profile of icovamenib HPMC capsule formulation in fed states	Tlag	Every other day for a max of 2 weeks
Evaluate food effect and PK profile of icovamenib HPMC capsule formulation in fed states	Clast	Every other day for a max of 2 weeks
Assess safety and tolerability of icovamenib as capsule and HPMC capsule	Incidence of adverse events (AEs)	Every other day for a max of 2 weeks
Assess safety and tolerability in vital signs of icovamenib as capsule and HPMC capsule	Blood pressure (mmHg)	Every other day for a max of 2 weeks
Assess safety and tolerability in vital signs of icovamenib as capsule and HPMC capsule	Heart rate (beats per minute)	Every other day for a max of 2 weeks
Assess safety and tolerability in ECG of icovamenib as capsule and HPMC capsule	Heart rate (beats per minute)	Every other day for a max of 2 weeks
Assess safety and tolerability in ECG of icovamenib as capsule and HPMC capsule	PR interval (ms)	Every other day for a max of 2 weeks
Assess safety and tolerability in ECG of icovamenib as capsule and HPMC capsule	QRS interval (ms)	Every other day for a max of 2 weeks
Assess safety and tolerability in ECG of icovamenib as capsule and HPMC capsule	QT interval (ms)	Every other day for a max of 2 weeks
Assess safety and tolerability in ECG of icovamenib as capsule and HPMC capsule	QTcF interval (ms)	Every other day for a max of 2 weeks
Number of participants with abnormal physical examination	General appearance	Every other day for a max of 2 weeks
Number of participants with abnormal laboratory test findings	Clinical chemistry such as alanine aminotransferase (U/L), aspartate aminotransferase (U/L), alkaline phosphatase (U/L), total bilirubin (mg/dL)	Every other day for a max of 2 weeks
Number of participants with abnormal laboratory test findings	Hematology such as red blood cell (x 10^6/uL), white blood cell (x 10^3/uL), and platelet count (x 10^3/uL)	Every other day for a max of 2 weeks
Number of participants with abnormal laboratory test findings	Coagulation such as fibrinogen (mg/dL), prothrombin time (s), international normalized ratio (no units)	Every other day for a max of 2 weeks
Number of participants with abnormal urine test findings	Urinalysis such as color (no units), appearance (no units), pH (pH)	Every other day for a max of 2 weeks

Collaborators and Investigators

• Sponsor: Biomea Fusion Inc.
• Investigators: Study Director: Biomea Fusion Inc., Biomea Fusion Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2025
• Primary Completion (Actual): January 14, 2026
• Study Completion (Actual): January 14, 2026

Study Registration Dates

• First Submitted: October 10, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Healthy Volunteer; Food Effect
• Other Study ID Numbers: COVALENT-121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No