Food Effect Study in Healthy Volunteers

Biomea Fusion

Status and phase: Active, not recruiting; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Icovamenib HPMC; Drug: Icovamenib

Study type: Interventional

Funder types: Industry

Identifiers

NCT07254286

COVALENT-121

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 9 patient groups

Regimen A

Experimental group

Description:

A - icovamenib capsule 100mg in fasted state

Treatment:

Drug: Icovamenib

Regimen B

Experimental group

Description:

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

Treatment:

Drug: Icovamenib

Regimen C

Experimental group

Description:

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

Treatment:

Drug: Icovamenib

Regimen D

Experimental group

Description:

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

Treatment:

Drug: Icovamenib

Regimen E

Experimental group

Description:

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

Treatment:

Drug: Icovamenib

Regimen F

Experimental group

Description:

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

Treatment:

Drug: Icovamenib HPMC

Regimen G

Experimental group

Description:

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

Treatment:

Drug: Icovamenib HPMC

Regimen H

Experimental group

Description:

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

Treatment:

Drug: Icovamenib HPMC

Regimen I

Experimental group

Description:

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

Treatment:

Drug: Icovamenib HPMC