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Healthy VolunteerPhase 1NCT07254286

Food Effect Study in Healthy Volunteers

A Phase 1 study testing Icovamenib and Icovamenib HPMC in people with Healthy Volunteer, run by Biomea Fusion Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteer
What is being tested?
Icovamenib and Icovamenib HPMC
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
11 Sep 2025to 14 Jan 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • Medical/Surgical History and Mental Health
  • 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.
  • History of hypertension or untreated hypertension (systolic blood pressure (BP) >140 mmHg and/or diastolic BP >90 mmHg).
  • Known self or family history (first-degree relative) of multiple endocrine neoplasia Type 1.
  • History of stomach or intestinal surgery or resection (except appendectomy, hernia and/or cholecystectomy).
  • Diagnostic assessments.
Show all 16Show fewer
  • Clinically significant abnormal clinical chemistry, hematology, coagulation or urinalysis as judged by the investigator.
  • History or evidence of hepatitis C virus (HCV), or hepatitis B virus (HBV) infection or human immunodeficiency virus (HIV) at screening.
  • Estimated creatinine clearance (CLcr) of <90 mL/min.
  • AST, ALT or bilirubin > ULN at screening.
  • Prior Study Participation.
  • Subjects who have received any IMP in a clinical research study within 5 half-lives or within 30 days prior to first dose.
  • Prior and Concomitant Medication.
  • 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.
  • Currently dieting (formal weight loss program) and/or are currently using or have used within 2 months of screening any drugs for weight management.
  • Received prior menin inhibitor treatment.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Quotient Sciences - Miami, Inc.

    Miami, Florida, 33126

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Icovamenib, Icovamenib HPMC
Keywords
Healthy Volunteer, Food Effect

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IcovamenibDrug

    Also called BMF-219

    Investigational Product

  • Icovamenib HPMCDrug

    Also called BMF-219 HPMC

    Investigational Product

Study groups in NCT07254286
Study groupRoleWhat they receive
Regimen AExperimentalA - icovamenib capsule 100mg in fasted state
Receives: Drug: Icovamenib
Regimen BExperimentalB - icovamenib capsule 100mg in the fed state (0.5 h after initiation of low-fat breakfast)
Receives: Drug: Icovamenib
Regimen CExperimentalC - icovamenib capsule 100mg in the fed state (1 h after initiation of a low-fat breakfast)
Receives: Drug: Icovamenib
Regimen DExperimentalD - icovamenib capsule 100mg in the fed state (0.5 h after initiation of a high-fat breakfast)
Receives: Drug: Icovamenib
Regimen EExperimentalE - icovamenib capsule 100mg in the fed state (1 h after initiation of a high-fat breakfast)
Receives: Drug: Icovamenib
Regimen FExperimentalF - icovamenib HPMC capsule 100mg in the fed state (0.5 h after initiation of a high-fat breakfast)
Receives: Drug: Icovamenib HPMC
Regimen GExperimentalG - icovamenib HPMC capsule 100mg in the fed state (1h after initiation of a high-fat breakfast)
Receives: Drug: Icovamenib HPMC
Regimen HExperimentalH - icovamenib HPMC capsule 100mg in the fed state (0.5 h after initiation of a low-fat breakfast)
Receives: Drug: Icovamenib HPMC
Regimen IExperimentalI - icovamenib HPMC capsule 100mg in the fed state (1 h after initiation of a low-fat breakfast)
Receives: Drug: Icovamenib HPMC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate food effect and PK profile of icovamenib capsule formulation in fed and fasted states

    Tmax

    Measured: Every other day for a max of 2 weeks

  2. Evaluate food effect and PK profile of icovamenib capsule formulation in fed and fasted states

    Cmax

    Measured: Every other day for a max of 2 weeks

  3. Evaluate food effect and PK profile of icovamenib capsule formulation in fed and fasted states

    AUC (0-last)

    Measured: Every other day for a max of 2 weeks

  4. Evaluate food effect and PK profile of icovamenib capsule formulation in fed and fasted states

    AUC (0-inf)

    Measured: Every other day for a max of 2 weeks

  5. Evaluate food effect and PK profile of icovamenib capsule formulation in fed and fasted states

    T1/2

    Measured: Every other day for a max of 2 weeks

  6. Evaluate food effect and PK profile of icovamenib capsule formulation in fed and fasted states

    MRT (0-inf)

    Measured: Every other day for a max of 2 weeks

  7. Evaluate food effect and PK profile of icovamenib capsule formulation in fed and fasted states

    Tlag

    Measured: Time Frame: Every other day for a max of 2 weeks

Secondary outcomes (21)

  1. Evaluate food effect and PK profile of icovamenib HPMC capsule formulation in fed states

    Tmax

    Measured: Every other day for a max of 2 weeks

  2. Evaluate food effect and PK profile of icovamenib HPMC capsule formulation in fed states

    Cmax

    Measured: Every other day for a max of 2 weeks

  3. Evaluate food effect and PK profile of icovamenib HPMC capsule formulation in fed states

    AUC (0-last)

    Measured: Every other day for a max of 2 weeks

  4. Evaluate food effect and PK profile of icovamenib HPMC capsule formulation in fed states

    AUC (0-inf)

    Measured: Every other day for a max of 2 weeks

  5. Evaluate food effect and PK profile of icovamenib HPMC capsule formulation in fed states

    T1/2

    Measured: Every other day for a max of 2 weeks

  6. Evaluate food effect and PK profile of icovamenib HPMC capsule formulation in fed states

    MRT(0-inf)

    Measured: Every other day for a max of 2 weeks

  7. Evaluate food effect and PK profile of icovamenib HPMC capsule formulation in fed states

    Tlag

    Measured: Every other day for a max of 2 weeks

  8. Evaluate food effect and PK profile of icovamenib HPMC capsule formulation in fed states

    Clast

    Measured: Every other day for a max of 2 weeks

  9. Assess safety and tolerability of icovamenib as capsule and HPMC capsule

    Incidence of adverse events (AEs)

    Measured: Every other day for a max of 2 weeks

  10. Assess safety and tolerability in vital signs of icovamenib as capsule and HPMC capsule

    Blood pressure (mmHg)

    Measured: Every other day for a max of 2 weeks

  11. Assess safety and tolerability in vital signs of icovamenib as capsule and HPMC capsule

    Heart rate (beats per minute)

    Measured: Every other day for a max of 2 weeks

  12. Assess safety and tolerability in ECG of icovamenib as capsule and HPMC capsule

    Heart rate (beats per minute)

    Measured: Every other day for a max of 2 weeks

  13. Assess safety and tolerability in ECG of icovamenib as capsule and HPMC capsule

    PR interval (ms)

    Measured: Every other day for a max of 2 weeks

  14. Assess safety and tolerability in ECG of icovamenib as capsule and HPMC capsule

    QRS interval (ms)

    Measured: Every other day for a max of 2 weeks

  15. Assess safety and tolerability in ECG of icovamenib as capsule and HPMC capsule

    QT interval (ms)

    Measured: Every other day for a max of 2 weeks

  16. Assess safety and tolerability in ECG of icovamenib as capsule and HPMC capsule

    QTcF interval (ms)

    Measured: Every other day for a max of 2 weeks

  17. Number of participants with abnormal physical examination

    General appearance

    Measured: Every other day for a max of 2 weeks

  18. 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)

    Measured: Every other day for a max of 2 weeks

  19. 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)

    Measured: Every other day for a max of 2 weeks

  20. Number of participants with abnormal laboratory test findings

    Coagulation such as fibrinogen (mg/dL), prothrombin time (s), international normalized ratio (no units)

    Measured: Every other day for a max of 2 weeks

  21. Number of participants with abnormal urine test findings

    Urinalysis such as color (no units), appearance (no units), pH (pH)

    Measured: Every other day for a max of 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2025
  2. Study start11 Sep 2025
  3. Primary completion14 Jan 2026
  4. Study completion14 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a Phase 1, open-label, randomized, single dose, up to 7-way crossover study.
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07254286
Sponsor's protocol ID
COVALENT-121
Status last verified
Feb 2026
First submitted
10 Oct 2025
Last updated
11 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Icovamenib and Icovamenib HPMC in people with Healthy Volunteer, run by Biomea Fusion Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07254286.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.

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