Food Effect Study in Healthy Volunteers

February 10, 2026 updated by: Biomea Fusion Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluate food effect and PK profile of icovamenib capsule formulation in fed and fasted states
Time Frame: Every other day for a max of 2 weeks
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
Time Frame: Every other day for a max of 2 weeks
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
Time Frame: Every other day for a max of 2 weeks
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
Time Frame: Every other day for a max of 2 weeks
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
Time Frame: Every other day for a max of 2 weeks
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
Time Frame: Every other day for a max of 2 weeks
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
Time Frame: Time Frame: Every other day for a max of 2 weeks
Tlag
Time Frame: Every other day for a max of 2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluate food effect and PK profile of icovamenib HPMC capsule formulation in fed states
Time Frame: Every other day for a max of 2 weeks
Tmax
Every other day for a max of 2 weeks
Evaluate food effect and PK profile of icovamenib HPMC capsule formulation in fed states
Time Frame: Every other day for a max of 2 weeks
Cmax
Every other day for a max of 2 weeks
Evaluate food effect and PK profile of icovamenib HPMC capsule formulation in fed states
Time Frame: Every other day for a max of 2 weeks
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
Time Frame: Every other day for a max of 2 weeks
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
Time Frame: Every other day for a max of 2 weeks
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
Time Frame: Every other day for a max of 2 weeks
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
Time Frame: Every other day for a max of 2 weeks
Tlag
Every other day for a max of 2 weeks
Evaluate food effect and PK profile of icovamenib HPMC capsule formulation in fed states
Time Frame: Every other day for a max of 2 weeks
Clast
Every other day for a max of 2 weeks
Assess safety and tolerability of icovamenib as capsule and HPMC capsule
Time Frame: Every other day for a max of 2 weeks
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
Time Frame: Every other day for a max of 2 weeks
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
Time Frame: Every other day for a max of 2 weeks
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
Time Frame: Every other day for a max of 2 weeks
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
Time Frame: Every other day for a max of 2 weeks
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
Time Frame: Every other day for a max of 2 weeks
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
Time Frame: Every other day for a max of 2 weeks
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
Time Frame: Every other day for a max of 2 weeks
QTcF interval (ms)
Every other day for a max of 2 weeks
Number of participants with abnormal physical examination
Time Frame: Every other day for a max of 2 weeks
General appearance
Every other day for a max of 2 weeks
Number of participants with abnormal laboratory test findings
Time Frame: Every other day for a max of 2 weeks
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
Time Frame: Every other day for a max of 2 weeks
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
Time Frame: Every other day for a max of 2 weeks
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
Time Frame: Every other day for a max of 2 weeks
Urinalysis such as color (no units), appearance (no units), pH (pH)
Every other day for a max of 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biomea Fusion Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Biomea Fusion Inc., Biomea Fusion Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 11, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 14, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 14, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Volunteer

Clinical Trials on Icovamenib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings