A Phase 1, Single Blind, Parallel-arm Trial to Assess the Potential for Pharmacodynamic Interaction of Centanafadine When Co-administered With Stimulants in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from Baseline in Blood Pressure (BP) at Day 12 or Early Termination (ET)
研究概览
简要总结
This study will look at how centanafadine works when taken together with stimulant medicines in healthy adults, and whether combining them affects how the body responds.
详细描述
This is a single dose crossover study. Participants in each arm will receive 3 treatments in a 3 -sequence, 3-period, crossover design. In each arm, participants will be randomized to 1 of 3 treatment sequences: Sequence 1: ABC, Sequence 2: BCA, or Sequence 3: CAB.
Here's what each treatment incudes:
- Treatment A - centanafadine alone in both Arms 1 and 2.
- Treatment B - methylphenidate alone in Arm 1 and lisdexamfetamine alone in Arm 2.
- Treatment C - centanafadine combined with methylphenidate in Arm 1, and centanafadine combined with lisdexamfetamine in Arm 2.
The duration of trial participation for each participant will be approximately 44 days, and the overall trial duration is expected to be approximately 3 months.
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
- Single (Participant)
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 (BMI) between 18.0 to 32.0 kilogram per square meter (kg/m2).
- •Must be in good health, based on:
- •Medical history
- •Physical examination
- •Heart test (Electrocardiogram [ECG])
- •Lab tests (blood, urine and other routine checks)
- •Willing to stay in the clinic for the required time and agree to a follow-up phone call for safety.
- •Able to sign informed consent and, in the investigator's opinion, follow all trial requirements.
排除标准
- •History of drug and/or alcohol abuse in past 2 years.
- •History of or current hepatitis or acquired immune deficiency syndrome (AIDS) or carriers of hepatitis B surface antigen (HBsAg) and/or anti-hepatitis C virus (HCV), or human immunodeficiency virus (HIV) antibodies.
- •Known drug allergy or hypersensitivity.
- •Any history of significant bleeding problems.
- •Difficulty donating blood in the past.
- •Use of tobacco or exposure to second-hand smoke in the past 2 months, or high cotinine levels in blood/urine.
- •Uncontrolled high blood pressure (BP) (systolic blood pressure [SBP] > 140 millimeters of mercury (mmHg) or diastolic blood pressure [DBP] > 90 mmHg) or symptomatic low blood pressure, or orthostatic hypotension (large BP drop when standing).
- •History of unexplained fainting (syncope).
- •Serious mental health disorders that could interfere with participation.
研究组 & 干预措施
Arm 1, Sequence 1: ABC
Participants will receive dosing of centanafadine alone (A), once daily (QD) extended release (XR) capsule on Day 1 followed by methylphenidate alone (B), tablet, QD on Day 5, further followed by centanafadine, QD XR capsule along with methylphenidate, tablet (C), QD on Day 9. There will be a washout period of 96 hours between each dosing.
干预措施: Centanafadine (Drug)
Arm 2, Sequence 2: BCA
Participants will receive dosing of lisdexamfetamine alone, capsule (B), QD on Day 1, followed by centanafadine, QD XR capsule along with lisdexamfetamine, capsule (C), QD on Day 5, further followed by centanafadine alone, QD XR capsule (A) on Day 9. There will be a washout period of 96 hours between each dosing.
干预措施: Lisdexamfetamine (Drug)
Arm 2, Sequence 3: CAB
Participants will receive dosing of centanafadine, QD XR capsule along with lisdexamfetamine, capsule (C), QD on Day 1, followed by centanafadine alone, QD XR capsule (A) on Day 5, further followed by lisdexamfetamine alone, capsule (B), QD on Day 9. There will be a washout period of 96 hours between each dosing.
干预措施: Centanafadine (Drug)
Arm 1, Sequence 2: BCA
Participants will receive dosing of methylphenidate alone (B), tablet, QD on Day 1, followed by centanafadine, QD XR capsule along with methylphenidate, tablet (C), QD on Day 5, further followed by centanafadine alone, QD XR capsule (A) on Day 9. There will be a washout period of 96 hours between each dosing.
干预措施: Methylphenidate (Drug)
Arm 1, Sequence 1: ABC
Participants will receive dosing of centanafadine alone (A), once daily (QD) extended release (XR) capsule on Day 1 followed by methylphenidate alone (B), tablet, QD on Day 5, further followed by centanafadine, QD XR capsule along with methylphenidate, tablet (C), QD on Day 9. There will be a washout period of 96 hours between each dosing.
干预措施: Methylphenidate (Drug)
Arm 1, Sequence 2: BCA
Participants will receive dosing of methylphenidate alone (B), tablet, QD on Day 1, followed by centanafadine, QD XR capsule along with methylphenidate, tablet (C), QD on Day 5, further followed by centanafadine alone, QD XR capsule (A) on Day 9. There will be a washout period of 96 hours between each dosing.
干预措施: Centanafadine (Drug)
Arm 1, Sequence 3: CAB
Participants will receive dosing of centanafadine, QD XR capsule along with methylphenidate, tablet (C), QD on Day 1, followed by centanafadine alone, QD XR capsule (A) on Day 5, further followed by methylphenidate alone, tablet (B), QD on Day 9. There will be a washout period of 96 hours between each dosing.
干预措施: Centanafadine (Drug)
Arm 1, Sequence 3: CAB
Participants will receive dosing of centanafadine, QD XR capsule along with methylphenidate, tablet (C), QD on Day 1, followed by centanafadine alone, QD XR capsule (A) on Day 5, further followed by methylphenidate alone, tablet (B), QD on Day 9. There will be a washout period of 96 hours between each dosing.
干预措施: Methylphenidate (Drug)
Arm 2, Sequence 1: ABC
Participants will receive dosing of centanafadine alone, QD XR capsule (A) on Day 1 followed by lisdexamfetamine alone, capsule (B), QD on Day 5, further followed by centanafadine, QD XR capsule along with lisdexamfetamine, capsule (C), QD on Day 9. There will be a washout period of 96 hours between each dosing.
干预措施: Centanafadine (Drug)
Arm 2, Sequence 1: ABC
Participants will receive dosing of centanafadine alone, QD XR capsule (A) on Day 1 followed by lisdexamfetamine alone, capsule (B), QD on Day 5, further followed by centanafadine, QD XR capsule along with lisdexamfetamine, capsule (C), QD on Day 9. There will be a washout period of 96 hours between each dosing.
干预措施: Lisdexamfetamine (Drug)
Arm 2, Sequence 2: BCA
Participants will receive dosing of lisdexamfetamine alone, capsule (B), QD on Day 1, followed by centanafadine, QD XR capsule along with lisdexamfetamine, capsule (C), QD on Day 5, further followed by centanafadine alone, QD XR capsule (A) on Day 9. There will be a washout period of 96 hours between each dosing.
干预措施: Centanafadine (Drug)
Arm 2, Sequence 3: CAB
Participants will receive dosing of centanafadine, QD XR capsule along with lisdexamfetamine, capsule (C), QD on Day 1, followed by centanafadine alone, QD XR capsule (A) on Day 5, further followed by lisdexamfetamine alone, capsule (B), QD on Day 9. There will be a washout period of 96 hours between each dosing.
干预措施: Lisdexamfetamine (Drug)
结局指标
主要结局
Change from Baseline in Blood Pressure (BP) at Day 12 or Early Termination (ET)
时间窗: Baseline, Day 12 or ET
Change from Baseline in Heart Rate (HR) at Day 12 or ET
时间窗: Baseline, Day 12 or ET
次要结局
- Area under the concentration time curve from time zero to the time of the last observable concentration at time (AUC0-12 hours) for Centanafadine when co-administered with methylphenidate or lisdexamfetamine(Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose)
- Maximal peak plasma concentration (Cmax) for Centanafadine when co-administered with methylphenidate or lisdexamfetamine(Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose)
- Area under the concentration time curve from time zero to infinity (AUC-inf) for Centanafadine when co-administered with methylphenidate or lisdexamfetamine(Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose)
- Time to maximum (peak) Plasma Concentration (Tmax) for Centanafadine when co-administered with methylphenidate or lisdexamfetamine(Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose)
- Volume of distribution following extravascular administration (Vz/F) for Centanafadine when co-administered with methylphenidate or lisdexamfetamine(Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose)
- Terminal phase elimination half-life (t1/2,z) for Centanafadine when co-administered with methylphenidate or lisdexamfetamine(Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose)
- Apparent clearance of drug from plasma after extravascular administration (CL/F) for Centanafadine when co-administered with methylphenidate or lisdexamfetamine(Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose)