A Phase 1 Open-Label, Randomized, Crossover Food Effect and Formulation Assessment for Icovamenib Capsule in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluate food effect and PK profile of icovamenib capsule formulation in fed and fasted states
研究概览
简要总结
A phase 1 open-label, randomized, crossover food effect and formulation assessment for icovamenib capsule in healthy volunteers.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
- •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.
研究组 & 干预措施
Regimen A
A - icovamenib capsule 100mg in fasted state
干预措施: Icovamenib (Drug)
Regimen B
B - icovamenib capsule 100mg in the fed state (0.5 h after initiation of low-fat breakfast)
干预措施: Icovamenib (Drug)
Regimen C
C - icovamenib capsule 100mg in the fed state (1 h after initiation of a low-fat breakfast)
干预措施: Icovamenib (Drug)
Regimen D
D - icovamenib capsule 100mg in the fed state (0.5 h after initiation of a high-fat breakfast)
干预措施: Icovamenib (Drug)
Regimen E
E - icovamenib capsule 100mg in the fed state (1 h after initiation of a high-fat breakfast)
干预措施: Icovamenib (Drug)
Regimen F
F - icovamenib HPMC capsule 100mg in the fed state (0.5 h after initiation of a high-fat breakfast)
干预措施: Icovamenib HPMC (Drug)
Regimen G
G - icovamenib HPMC capsule 100mg in the fed state (1h after initiation of a high-fat breakfast)
干预措施: Icovamenib HPMC (Drug)
Regimen H
H - icovamenib HPMC capsule 100mg in the fed state (0.5 h after initiation of a low-fat breakfast)
干预措施: Icovamenib HPMC (Drug)
Regimen I
I - icovamenib HPMC capsule 100mg in the fed state (1 h after initiation of a low-fat breakfast)
干预措施: Icovamenib HPMC (Drug)
结局指标
主要结局
Evaluate food effect and PK profile of icovamenib capsule formulation in fed and fasted states
时间窗: Time Frame: Every other day for a max of 2 weeks
Tlag
Evaluate food effect and PK profile of icovamenib capsule formulation in fed and fasted states
时间窗: Every other day for a max of 2 weeks
Tmax
次要结局
- Assess safety and tolerability of icovamenib as capsule and HPMC capsule(Every other day for a max of 2 weeks)
- Number of participants with abnormal physical examination(Every other day for a max of 2 weeks)
- Number of participants with abnormal urine test findings(Every other day for a max of 2 weeks)
- Evaluate food effect and PK profile of icovamenib HPMC capsule formulation in fed states(Every other day for a max of 2 weeks)
- Assess safety and tolerability in vital signs of icovamenib as capsule and HPMC capsule(Every other day for a max of 2 weeks)
- Assess safety and tolerability in ECG of icovamenib as capsule and HPMC capsule(Every other day for a max of 2 weeks)
- Number of participants with abnormal laboratory test findings(Every other day for a max of 2 weeks)