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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen A | Experimental | A - icovamenib capsule 100mg in fasted state |
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| Regimen B | Experimental | B - icovamenib capsule 100mg in the fed state (0.5 h after initiation of low-fat breakfast) |
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| Regimen C | Experimental | C - icovamenib capsule 100mg in the fed state (1 h after initiation of a low-fat breakfast) |
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| Regimen D | Experimental | D - icovamenib capsule 100mg in the fed state (0.5 h after initiation of a high-fat breakfast) |
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| Regimen E | Experimental | E - icovamenib capsule 100mg in the fed state (1 h after initiation of a high-fat breakfast) |
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| Regimen F | Experimental | F - icovamenib HPMC capsule 100mg in the fed state (0.5 h after initiation of a high-fat breakfast) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Icovamenib | Drug | Investigational Product |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate food effect and PK profile of icovamenib HPMC capsule formulation in fed states | Tmax | Every other day for a max of 2 weeks |
| Evaluate food effect and PK profile of icovamenib HPMC capsule formulation in fed states |
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Inclusion Criteria:
Informed Consent and Compliance
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Biomea Fusion Inc. | Biomea Fusion Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences - Miami, Inc. | Miami | Florida | 33126 | United States |
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This is a Phase 1, open-label, randomized, single dose, up to 7-way crossover study.
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| Regimen G | Experimental | G - icovamenib HPMC capsule 100mg in the fed state (1h after initiation of a high-fat breakfast) |
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| Regimen H | Experimental | H - icovamenib HPMC capsule 100mg in the fed state (0.5 h after initiation of a low-fat breakfast) |
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| Regimen I | Experimental | I - icovamenib HPMC capsule 100mg in the fed state (1 h after initiation of a low-fat breakfast) |
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| Icovamenib HPMC | Drug | Investigational Product |
|
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Cmax
| 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) | 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) | 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 | 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) | Every other day for a max of 2 weeks |
| Evaluate food effect and PK profile of icovamenib HPMC capsule formulation in fed states | Tlag | Every other day for a max of 2 weeks |
| Evaluate food effect and PK profile of icovamenib HPMC capsule formulation in fed states | Clast | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | Every other day for a max of 2 weeks |
| Number of participants with abnormal physical examination | General appearance | 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) | 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) | 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) | 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) | Every other day for a max of 2 weeks |