Healthy Volunteer
Conditions
Keywords
Healthy Volunteer, Food Effect
Brief summary
A phase 1 open-label, randomized, crossover food effect and formulation assessment for icovamenib capsule in healthy volunteers.
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.
Interventions
DRUGIcovamenib
Investigational Product
DRUGIcovamenib HPMC
Investigational Product
Sponsors
Biomea Fusion Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a Phase 1, open-label, randomized, single dose, up to 7-way crossover study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate food effect and PK profile of icovamenib capsule formulation in fed and fasted states | Every other day for a max of 2 weeks | Tmax |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate food effect and PK profile of icovamenib HPMC capsule formulation in fed states | Every other day for a max of 2 weeks | Tmax |
| Assess safety and tolerability of icovamenib as capsule and HPMC capsule | Every other day for a max of 2 weeks | Incidence of adverse events (AEs) |
| Assess safety and tolerability in vital signs of icovamenib as capsule and HPMC capsule | Every other day for a max of 2 weeks | Blood pressure (mmHg) |
| Assess safety and tolerability in ECG of icovamenib as capsule and HPMC capsule | Every other day for a max of 2 weeks | Heart rate (beats per minute) |
| Number of participants with abnormal physical examination | Every other day for a max of 2 weeks | General appearance |
| Number of participants with abnormal laboratory test findings | Every other day for a max of 2 weeks | Clinical chemistry such as alanine aminotransferase (U/L), aspartate aminotransferase (U/L), alkaline phosphatase (U/L), total bilirubin (mg/dL) |
| Number of participants with abnormal urine test findings | Every other day for a max of 2 weeks | Urinalysis such as color (no units), appearance (no units), pH (pH) |
Countries
United States
Contacts
STUDY_DIRECTORBiomea Fusion Inc.
Biomea Fusion Inc.
Outcome results
None listed