Food Effect Study in Healthy Volunteers

Biomea Fusion Inc.60 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteer

Interventions

IcovamenibDRUG

Investigational Product

Icovamenib HPMCDRUG

Investigational Product

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Quotient Sciences - Miami, Inc.

Miami, Florida, United States

Outcomes

Primary Outcomes

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

Tmax

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: 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)

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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Time frame: Every other day for a max of 2 weeks

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

Cmax

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: 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)

Time frame: Every other day for a max of 2 weeks

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

Tlag

Time frame: Every other day for a max of 2 weeks

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

Clast

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: Every other day for a max of 2 weeks

Number of participants with abnormal physical examination

General appearance

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: Every other day for a max of 2 weeks