临床试验/NCT06793943

NCT06793943已完成1 期

A Phase 1, Open-Label, 4-Part Trial to Assess the Drug-Drug Interaction Between Zasocitinib and Combined Oral Contraceptives, a MATE Substrate, a P-gp Substrate, and a Proton-Pump Inhibitor in Healthy Participants

Takeda1 个研究点分布在 1 个国家目标入组 78 人开始时间: 2025年1月23日最近更新: 2025年4月4日

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 78
试验地点: 1
主要终点: Part 1: Cmax: Maximum Observed Plasma Concentration for LNG and EE When Administered Alone and With Zasocitinib

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研究点记录与标识符相似试验

研究概览

简要总结

The main aim of this study is to find out how zasocitinib (TAK-279) interacts with other medicines taken by mouth (orally). This will be examined by how the body processes medicines, which is called pharmacokinetics or PK. In this study, other medicines that will be administered together with zasocitinib include a contraceptive (levonorgestrel (LNG) and ethinyl estradiol [EE]), a medicine for diabetes (metformin), a medicine used for heart problems (digoxin), and a medicine that blocks the production of stomach acid (esomeprazole).

Another aim is to learn about the side effects of zasocitinib and how well it is tolerated when taken alone and together with these other medicines.

During the study, participants will need to stay at the clinic for up to 27 days.

详细描述

The drug being tested in this study is called zasocitinib.

Zasocitinib is being tested to assess the effect of zasocitinib on the pharmacokinetics of Combined Oral Contraceptive (COC [containing LNG and EE] in Part 1), multidrug and toxic compound extrusion (MATE) substrate (metformin in Part 2), and a P-glycoprotein (P-gp) substrate (digoxin in Part 3). Additionally, the effect of proton-pump inhibitor (PPI) (esomeprazole in Part 4) on the pharmacokinetics of zasocitinib is being evaluated in healthy participants.

The study will enroll approximately 78 participants. Participants will be enrolled in one of the four parts to evaluate the following treatments:

Part 1: COC (LNG and EE) + Zasocitinib
Part 2: Metformin + Zasocitinib
Part 3: Digoxin + Zasocitinib
Part 4: Zasocitinib + Esomeprazole

The overall time (including screening and follow-up periods) to participate is approximately 68 days for Part 1, 54 days for Part 2, 62 days for Part 3 and 56 days for Part 4. All participants will be followed up for up to 14 days after the last dose of Period 2 in each Part.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Other
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

未提供

排除标准

未提供

研究组 & 干预措施

Part 3: Digoxin + Zasocitinib

Experimental

干预措施: Digoxin (Drug)

Part 4: Zasocitinib + Esomeprazole

Experimental

干预措施: Esomeprazole (Drug)

Part 4: Zasocitinib + Esomeprazole

Experimental

干预措施: Zasocitinib (Drug)

Part 2: Metformin + Zasocitinib

Experimental

干预措施: Metformin (Drug)

Part 3: Digoxin + Zasocitinib

Experimental

干预措施: Zasocitinib (Drug)

Part 1: COC (LNG and EE) + Zasocitinib

Experimental

干预措施: Zasocitinib (Drug)

Part 1: COC (LNG and EE) + Zasocitinib

Experimental

干预措施: COC (Drug)

Part 2: Metformin + Zasocitinib

Experimental

干预措施: Zasocitinib (Drug)

结局指标

主要结局

Part 1: Cmax: Maximum Observed Plasma Concentration for LNG and EE When Administered Alone and With Zasocitinib

时间窗: Up to 144 hours

Part 1: AUCinf: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for LNG and EE When Administered Alone and With Zasocitinib

时间窗: Up to 144 hours

Part 1: AUClast: Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration for LNG and EE When Administered Alone and With Zasocitinib

时间窗: Up to 144 hours

Part 2: AUClast for Metformin When Administered Alone and With Zasocitinib

时间窗: Up to 48 hours

Part 2: Cmax for Metformin When Administered Alone and With Zasocitinib

时间窗: Up to 48 hours

Part 4: Cmax for Zasocitinib When Administered Alone and With Esomeprazole

时间窗: Up to 120 hours

Part 4: AUClast for Zasocitinib When Administered Alone and With Esomeprazole

时间窗: Up to 120 hours

Part 2: AUCinf for Metformin When Administered Alone and With Zasocitinib

时间窗: Up to 48 hours

Part 3: Cmax for Digoxin When Administered Alone and With Zasocitinib

时间窗: Up to 144 hours

Part 3: AUCinf for Digoxin When Administered Alone and With Zasocitinib

时间窗: Up to 144 hours

Part 3: AUClast for Digoxin When Administered Alone and With Zasocitinib

时间窗: Up to 144 hours

Part 4: AUCinf for Zasocitinib When Administered Alone and With Esomeprazole

时间窗: Up to 120 hours

次要结局

Parts 1, 2, 3 and 4: Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs)(Part 1: Up to 33 days; Part 2: Up to 23 days; Part 3: Up to 27 days; Part 4: Up to 23 days)

研究者

发起方

Takeda

申办方类型

Industry

责任方

Sponsor

研究点 (1)

Loading locations...

相似试验

已完成

1 期

Evaluation of the Pharmacokinetic Drug-drug Interactions Between VX-993 and Metformin in Healthy AdultsPain

NCT06523595Vertex Pharmaceuticals Incorporated31

已完成

1 期

A Single-Dose Study to Assess the Pharmacokinetics of Cabozantinib (XL184) Capsules in Subjects With Impaired Renal FunctionHealthyRenal Impairment

NCT01761773Exelixis32

已完成

1 期

TMC278-TiDP6-C136: Effect of TMC278 on Ethinylestradiol and Norethindrone in Healthy Women.HIVAIDSOral Contraceptive

NCT00739622Tibotec Pharmaceuticals, Ireland18

Unknown

2 期

A Trial Aiming to Assess the Safety and Activity of the Combination of Cabozantinib Plus Lanreotide in GEP and NETMetastatic Well Differentiated Neuroendocrine NeoplasmNeuroendocrine Tumors

NCT04427787Fondazione IRCCS Istituto Nazionale dei Tumori, Milano69

已完成

1 期

Cabozantinib in Combination With 13-cis-Retinoic Acid in Children With Relapsed or Refractory Solid TumorsSolid Tumor

NCT03611595Peter Zage15