A Phase 1, Randomized, Open-label, Parallel-arm Trial to Assess Relative Bioavailability of Centanafadine Sustained-Release (SR) Tablet to Once-Daily Extended-Release (QD XR) Capsule Following Oral Administration in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax) of Centanafadine
研究概览
简要总结
The purpose of this trial is to assess relative bioavailability of centanafadine (CTN) SR tablet to CTN QD XR capsule in healthy adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Body mass index from 19.0 to 32.0 kilograms per square meter (kg/m^2) (inclusive).
- •In good health as determined by:
- •Medical history
- •Physical examination
- •Electrocardiogram (ECG)
- •Serum/urine chemistry, hematology, and serology tests.
- •Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.
排除标准
- •Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving investigational medicinal product (IMP).
- •Clinically significant abnormality in past medical history, or at the screening physical examination, that in the investigator's or sponsor's opinion may place the participant at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug.
- •Consumption of alcohol and/or food and beverages containing caffeine, methylxanthines (e.g., coffee, chocolate) within 72 hours prior to dosing.
- •History of or current hepatitis or acquired immunodeficiency syndrome or carriers of hepatitis B surface antigen and/or hepatitis C antibodies, or human immunodeficiency virus antibodies.
- •History of any significant drug allergy or known or suspected hypersensitivity.
- •Any participant who, in the opinion of the investigator, should not participate in the trial.
研究组 & 干预措施
Arm 2: CTN 328.8 mg QD XR, Then CTN 400 mg TDD SR
Participants receive CTN 328.8 mg QD XR, capsule, orally on Day 1, then, they receive CTN 400 mg TDD SR, orally, on Day 4.
干预措施: Centanafadine SR (Drug)
Arm 2: CTN 328.8 mg QD XR, Then CTN 400 mg TDD SR
Participants receive CTN 328.8 mg QD XR, capsule, orally on Day 1, then, they receive CTN 400 mg TDD SR, orally, on Day 4.
干预措施: Centanafadine QD XR (Drug)
Arm 1: CTN 200 milligrams (mg) TDD SR, Then CTN 164.4 mg QD XR
Participants receive CTN 200 mg total daily dose (TDD) SR, tablet, orally on Day 1, then, they receive CTN 164.4 mg QD XR, capsule, orally on Day 4.
干预措施: Centanafadine SR (Drug)
Arm 1: CTN 200 milligrams (mg) TDD SR, Then CTN 164.4 mg QD XR
Participants receive CTN 200 mg total daily dose (TDD) SR, tablet, orally on Day 1, then, they receive CTN 164.4 mg QD XR, capsule, orally on Day 4.
干预措施: Centanafadine QD XR (Drug)
Arm 1: CTN 164.4 mg QD XR, Then CTN 200 mg TDD SR
Participants receive CTN 164.4 mg QD XR capsule, orally on Day 1, then, they receive CTN 200 mg TDD SR, tablet, orally on Day 4.
干预措施: Centanafadine SR (Drug)
Arm 1: CTN 164.4 mg QD XR, Then CTN 200 mg TDD SR
Participants receive CTN 164.4 mg QD XR capsule, orally on Day 1, then, they receive CTN 200 mg TDD SR, tablet, orally on Day 4.
干预措施: Centanafadine QD XR (Drug)
Arm 2: CTN 400 TDD mg SR, Then CTN 328.8 mg QD XR
Participants receive CTN 400 mg TDD SR, tablet, orally on Day 1, then, they receive CTN 328.8 mg QD XR, capsule, orally on Day 4.
干预措施: Centanafadine SR (Drug)
Arm 2: CTN 400 TDD mg SR, Then CTN 328.8 mg QD XR
Participants receive CTN 400 mg TDD SR, tablet, orally on Day 1, then, they receive CTN 328.8 mg QD XR, capsule, orally on Day 4.
干预措施: Centanafadine QD XR (Drug)
Arm 3: CTN 328.8 mg QD XR Fasted, Then CTN 328.8 mg QD XR Fed
Participants receive CTN 328.8 mg QD XR, capsule, orally in fasted state on Day 1, then, they receive CTN 328.8 mg QD XR, capsule, orally in fed state on Day 4.
干预措施: Centanafadine QD XR (Drug)
Arm 3: CTN 328.8 mg QD XR Fed, Then CTN 328.8 mg QD XR Fasted
Participants receive CTN 328.8 mg, QD XR, capsule, orally in fed state on Day 1, then, they receive CTN 328.8 mg QD XR, capsule, orally in fasted state on Day 4.
干预措施: Centanafadine QD XR (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) of Centanafadine
时间窗: Up to Day 6
Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at Time t (AUCt) of Centanafadine
时间窗: Up to Day 6
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinfinity) of Centanafadine
时间窗: Up to Day 6
次要结局
- Time to Maximum Plasma Concentration (Tmax) of Centanafadine(Up to Day 6)
- Terminal-phase Eimination Half-life (T1/2z) of Centanafadine(Up to Day 6)
- Apparent Clearance of Drug From Plasma After Extravascular Administration (CL/F) of Centanafadine(Up to Day 6)
- AUCt of Centanafadine Under Fasted and Fed Conditions(Up to Day 6)
- AUCinfinity of Centanafadine Under Fasted and Fed Conditions(Up to Day 6)
- Cmax of Centanafadine Under Fasted and Fed Conditions(Up to Day 6)