跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT07775261
NCT07775261尚未招募1 期

Interventional, Open-label, Fixed-sequence Crossover Trial Investigating the Effect of CYP3A4/5 Modulation on the Pharmacokinetics, Safety and Tolerability of Lu AH69593 and the Effect of Lu AH69593 on the Pharmacokinetics of a CYP3A4/5 Substrate in Healthy Participants

H. Lundbeck A/S0 个研究点目标入组 46 人开始时间: 2026年8月27日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
尚未招募
入组人数
46
主要终点
Parts A and B: Area Under the Lu AH69593 Plasma-concentration-time Curve from Zero to Infinity (AUC0-inf)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This trial will evaluate the effects of itraconazole (Part A) and, carbamazepine (Part B) on Lu AH69593, and the effect of Lu AH69593 on midazolam (Part C) in adult healthy participants. The main goals of this trial are to learn about

  1. the effect of other medicines on Lu AH69593
  2. the pharmacokinetic parameters of Lu AH69593 (how the drug is absorbed, distributed, and processed by the body), and
  3. the safety and tolerability of Lu AH69593.

研究设计

研究类型
Interventional
分配方式
Non 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

  • •The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, a neurological examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.
  • •The participant is willing and able to attend trial appointments within the specified time windows.
  • •The participant is willing to be an inpatient from the Baseline Visit to the Completion Visit.

排除标准

  • •The participant has taken any investigational medicinal product (IMP) <2 months or <5 halflives of that product, whichever is longer, prior to the first dose of IMP.
  • •The participant has had, in the opinion of the investigator, a clinically significant illness from which he/she recovered <4 weeks prior to the first dose of IMP.
  • •The participant has or has had, in the opinion of the investigator, any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.
  • •For Part B only: the participant tests positive for HLA-B*15:02 or HLA-A*31:01 allele.
  • •For Part B only: the participant has a personal or family history of Stevens-Johnson syndrome or toxic epidermal necrolysis.
  • •Additional protocol-defined criteria apply.

研究组 & 干预措施

Part B: Lu AH69593 + Carbamazepine

Experimental

干预措施: Carbamazepine (Drug)

Part A: Lu AH69593 + Itraconazole

Experimental

干预措施: Lu AH69593 (Drug)

Part B: Lu AH69593 + Carbamazepine

Experimental

干预措施: Lu AH69593 (Drug)

Part C: Lu AH69593 + Midazolam

Experimental

干预措施: Lu AH69593 (Drug)

Part A: Lu AH69593 + Itraconazole

Experimental

干预措施: Itraconazole (Drug)

Part C: Lu AH69593 + Midazolam

Experimental

干预措施: Midazolam (Drug)

结局指标

主要结局

Parts A and B: Area Under the Lu AH69593 Plasma-concentration-time Curve from Zero to Infinity (AUC0-inf)

时间窗: Up to Day 13

Parts A and B: Maximum Observed Plasma Concentration (Cmax) of Lu AH69593

时间窗: Up to Day 13

Part C: (AUC0-inf) of Midazolam

时间窗: Up to Day 9

Part C: Cmax of Midazolam

时间窗: Up to Day 9

次要结局

  • Parts A and B: Area Under the Lu AH69593 Plasma Concentration-time Curve From Zero to Last Quantifiable Time Point (AUC0-t)(Up to Day 13)
  • Parts A and B: Time to Maximum Observed Plasma Concentration (Tmax) of Lu AH69593(Up to Day 13)
  • Parts A and B: Apparent Oral Clearance for Lu AH69593 (CL/F)(Up to Day 13)
  • Number of Participants with Treatment-emergent Adverse Events (TEAEs)(Up to Day 25)
  • Parts A and B: Apparent Volume of Distribution for Lu AH69593 (Vz/F)(Up to Day 13)
  • Parts A and B: Terminal Elimination Half-life for Lu AH69593 (t1/2)(Up to Day 13)

研究者

申办方类型
Industry
责任方
Sponsor

相似试验

已完成
1 期
This study is to check the Drug-drug interaction of LXE408 with itraconazole and phenytoin
CTRI/2025/05/087526Novartis Healthcare Pvt Ltd40
已完成
1 期
A Study of the Effects of Itraconazole on LY4395089 in Healthy Participants
NCT07592572Eli Lilly and Company14
已完成
1 期
A Study to Learn if Itraconazole Changes How the Body Processes PF-07248144 (Study Medicine)
NCT07335419Pfizer12
招募中
1 期
A Trial to Test the Safety and Tolerability of Lu AH69593 in Adults That Are Healthy or Have Narcolepsy
NCT07613710H. Lundbeck A/S104
招募中
1 期
Drug-drug Interaction Study With AZD5335 and Itraconazole in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube CancerOvarian Cancer
NCT07402915AstraZeneca24