A Phase 1 Open-Label, Two-Period Study to Evaluate the Impact of Multiple Doses of Itraconazole on the Pharmacokinetics of Nacresertib in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of Nacresertib
研究概览
简要总结
This study will evaluate how multiple doses of Itraconazole Impacts the performance of Nacresertib in healthy adult participants
The goal of this study is to assess the safety and drug to drug interaction between Itraconazole and Nacresertib.
There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must voluntarily sign and date an informed consent, approved by an IEC/IRB, prior to the initiation of any screening or study-specific procedures.
- •Individuals 18 to 65 years of age at the time of screening.
- •Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
- •A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG.
- •Female participants meet the following criteria.
- •Non-Childbearing Potential due to meeting at least one of the following criteria:
- •Permanent sterility due to a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.
- •Non-surgical permanent infertility due to Mullerian agenesis, androgen insensitivity, or gonadal dysgenesis; investigator discretion should be applied to determining study entry.
- •Postmenopausal female who is age ≤ 55 years with no menses for 12 or more months without an alternative medical cause AND a follicle-stimulating hormone (FSH) level ≥ 30 IU/L.
- •Postmenopausal female who is age > 55 years with no menses for 12 or more months without an alternative medical cause.
排除标准
- •History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- •Participant has any clinically significant ECG abnormalities including the following:
- •Evidence of 2nd or 3rd degree atrioventricular (AV) block at screening visit or upon initial confinement
- •QT interval corrected for heart rate (QTc) using Fridericia's correction formula (QTcF) ˃ 450 msec (males) or ˃ 460 msec (females) at screening visit or upon initial confinement.
- •History of any clinically significant sensitivity or allergy to any medication or food.
- •History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption [e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.].
- •Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma, or localized carcinoma in situ of the cervix.
- •History or evidence of active tuberculosis (TB) disease or latent TB infection.
研究组 & 干预措施
Period 2: Nacresertib and Itraconazole
Participant will receive itraconazole multiple times on Day 1, followed by a single dose of itraconazole on Days 2 through 11. Participants will also receive a single oral dose of Nacresertib on Day 4.
干预措施: Nacresertib (Drug)
Period 1: Nacresertib Only
Participant receives single dose of Nacresertib administered on Day 1
干预措施: Nacresertib (Drug)
Period 2: Nacresertib and Itraconazole
Participant will receive itraconazole multiple times on Day 1, followed by a single dose of itraconazole on Days 2 through 11. Participants will also receive a single oral dose of Nacresertib on Day 4.
干预措施: Itraconazole (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of Nacresertib
时间窗: Up to Day 12
Cmax of Nacresertib
Time to Cmax (Tmax) of Nacresertib
时间窗: Up to Day 12
Tmax of Nacresertib
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of Nacresertib
时间窗: Up to Day 12
AUCt of Nacresertib
AUC From Time 0 to the Time Infinity (AUCinf) of Nacresertib
时间窗: Up to Day 12
AUCinf of Nacresertib
Terminal Phase Elimination Rate Constant (Beta) of Nacresertib
时间窗: Up to Day 12
Beta of Nacresertib
Terminal Phase Elimination Half-Life (t1/2) of Nacresertib
时间窗: Up to Day 12
t1/2 of Nacresertib
次要结局
未报告次要终点