Food Effect Study in Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy Volunteer

In brief

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

Key facts

Study ID

NCT07254286

Run by

Biomea Fusion Inc.

People needed

60

Starts

2025-09-11

Expected to finish

2026-01-14

Last updated by the study team

2026-02-11

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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.
• Received prior menin inhibitor treatment.

Where it is running

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

Full record on ClinicalTrials.gov

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