Food Effect Study in Healthy Volunteers

NCT07254286 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: COVALENT-121
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer; Food Effect

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (21)

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

  Every other day for a max of 2 weeks

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

  Every other day for a max of 2 weeks

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

  Every other day for a max of 2 weeks

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

  Every other day for a max of 2 weeks

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

  Every other day for a max of 2 weeks

Study Arms (9)

Regimen A

EXPERIMENTAL

A - icovamenib capsule 100mg in fasted state

Drug: Icovamenib

Regimen B

EXPERIMENTAL

B - icovamenib capsule 100mg in the fed state (0.5 h after initiation of low-fat breakfast)

Drug: Icovamenib

Regimen C

EXPERIMENTAL

C - icovamenib capsule 100mg in the fed state (1 h after initiation of a low-fat breakfast)

Drug: Icovamenib

Regimen D

EXPERIMENTAL

D - icovamenib capsule 100mg in the fed state (0.5 h after initiation of a high-fat breakfast)

Drug: Icovamenib

Regimen E

EXPERIMENTAL

E - icovamenib capsule 100mg in the fed state (1 h after initiation of a high-fat breakfast)

Drug: Icovamenib

Regimen F

EXPERIMENTAL

F - icovamenib HPMC capsule 100mg in the fed state (0.5 h after initiation of a high-fat breakfast)

Drug: Icovamenib HPMC

Regimen G

EXPERIMENTAL

G - icovamenib HPMC capsule 100mg in the fed state (1h after initiation of a high-fat breakfast)

Drug: Icovamenib HPMC

Regimen H

EXPERIMENTAL

H - icovamenib HPMC capsule 100mg in the fed state (0.5 h after initiation of a low-fat breakfast)

Drug: Icovamenib HPMC

Regimen I

EXPERIMENTAL

I - icovamenib HPMC capsule 100mg in the fed state (1 h after initiation of a low-fat breakfast)

Drug: Icovamenib HPMC

Interventions

Icovamenib DRUG

Investigational Product

Also known as: BMF-219

Regimen A; Regimen B; Regimen C; Regimen D; Regimen E

Icovamenib HPMC DRUG

Investigational Product

Also known as: BMF-219 HPMC

Regimen F; Regimen G; Regimen H; Regimen I

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Biomea Fusion Inc.: lead

Study Sites (1)

Quotient Sciences - Miami, Inc.

Miami, Florida, 33126, United States

Location

Study Officials

• Biomea Fusion Inc.

  Biomea Fusion Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Phase 1, open-label, randomized, single dose, up to 7-way crossover study.

Study Record Dates

• First Submitted: October 10, 2025
• First Posted: November 28, 2025
• Study Start: September 11, 2025
• Primary Completion: January 14, 2026
• Study Completion: January 14, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)