LTG-321 - Itraconazole Drug-drug Interaction (DDI) Study
A Phase 1, Open-Label Study to Evaluate the Effect of Strong CYP3A Inhibition on the Pharmacokinetics of LTG-321 in Healthy Participants
This Phase 1, single-center, open-label, randomized, parallel-group study will evaluate the effect of itraconazole on the PK of LTG-321 and its metabolite(s), and the safety and tolerability of LTG-321 administered alone and in combination with itraconazole, in healthy participants.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段1
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Healthy adults aged 18-55 years, inclusive.
- Body mass index (BMI) of 18.0-28.0 kg/m², inclusive.
- Willing to meet applicable contraception and reproductive restrictions during the study and for 90 days after the last study drug dose.
- Able to provide written informed consent and comply with study visits, procedures, and restrictions
Exclusion Criteria:
- Clinically significant medical conditions or abnormalities on examination, laboratory testing, vital signs, or ECG that could affect participant safety or study results.
- Gastrointestinal conditions that could affect drug absorption, or a history of gallstones or gallbladder removal.
- Pregnancy or breastfeeding.
- Relevant drug allergies or contraindications to LTG-321, itraconazole, or their ingredients.
- Recent smoking, vaping, or nicotine use; relevant substance or alcohol dependence history; or positive substance screening outside protocol-permitted exceptions.
- Use of prohibited medications, supplements, or vaccinations within protocol-specified periods.
- Known or confirmed hepatitis B, hepatitis C, or HIV infection, subject to protocol-defined exceptions.
- Previous participation in an LTG-321 study, recent participation in another investigational study, or recent blood or plasma donation within prohibited periods.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：LTG-321 Alone
|
LTG-321 is a novel, orally bioavailable, small molecule NaV1.8 inhibitor being developed as a non-opioid analgesic product |
|
实验性的：LTG-321 Plus Itraconazole
|
LTG-321 is a novel, orally bioavailable, small molecule NaV1.8 inhibitor being developed as a non-opioid analgesic product Itraconazole is a known strong CYP3A inhibitor |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Measurable Concentration (AUC0-last) of LTG-321 and Its Metabolite(s)
大体时间：Pre-dose through 240 hours after LTG-321 administration on Day 1 for Group A and Day 5 for Group B.
|
Area under the plasma concentration-time curve from dosing to the last measurable concentration, following LTG-321 administered alone or with itraconazole. |
Pre-dose through 240 hours after LTG-321 administration on Day 1 for Group A and Day 5 for Group B.
|
|
Maximum Observed Plasma Concentration (Cmax) of LTG-321 and Its Metabolite(s)
大体时间：Pre-dose through 240 hours after LTG-321 administration on Day 1 for Group A and Day 5 for Group B.
|
Maximum observed plasma concentration following LTG-321 administered alone or with itraconazole. |
Pre-dose through 240 hours after LTG-321 administration on Day 1 for Group A and Day 5 for Group B.
|
|
Terminal Elimination Half-Life (T1/2) of LTG-321 and Its Metabolite(s)
大体时间：Pre-dose through 240 hours after LTG-321 administration on Day 1 for Group A and Day 5 for Group B.
|
Terminal elimination half-life following LTG-321 administered alone or with itraconazole. |
Pre-dose through 240 hours after LTG-321 administration on Day 1 for Group A and Day 5 for Group B.
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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