NCT07216313已完成1 期
A Phase 1, Open-Label Study to Evaluate the Mutual Drug-Drug Interaction Potential Between Denifanstat and Resmetirom in Healthy Adult Participants
干预措施
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
- Area under the concentration-time curve during a dosing interval (tau) at steady state (AUC0-tau)
研究概览
简要总结
This is an open-label, 2-cohort study to evaluate the mutual DDI potential between denifanstat and resmetirom in healthy adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Additional inclusion and
排除标准
- •Inclusion Criteria:
- •Seated blood pressure is ≥ 90/40 mmHg and ≤ 140/90 mmHg at the screening visit.
- •Seated pulse rate is ≥ 40 bpm and ≤ 99 bpm at the screening visit.
- •QTcF interval is ≤ 460 msec (males) and ≤ 470 msec (females) and has ECG findings considered normal or not clinically significant by the PI or designee at the screening visit.
- •Liver function test including ALT, AST, ALP and total bilirubin ≤ upper limit of normal at the screening visit.
- •Estimated CrCL ≥ 80 mL/min at the screening visit.
- •Exclusion Criteria:
- •Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder.
- •History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (cholecystectomy will not be allowed; uncomplicated appendectomy and hernia repair will be allowed).
- •Presence of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines.
- •History or presence of hepatobiliary or thyroid-related disease.
- •Significant change (approximately 10% increase or decrease) in weight within 3 months prior to first dosing in the opinion of the PI or designee.
- •History of alcoholism or drug/chemical abuse within 2 years prior to check-in.
- •Positive results for HIV, HBsAg, or HCV at the screening visit.
- •Poor peripheral venous access.
研究组 & 干预措施
Cohort 2
Experimental
Effect of denifanstat on pharmacokinetics of resmetirom
干预措施: Denifanstat (Drug)
Cohort 2
Experimental
Effect of denifanstat on pharmacokinetics of resmetirom
干预措施: Resmetirom (Drug)
Cohort 1
Experimental
Effect of resmetirom on pharmacokinetics of denifanstat
干预措施: Denifanstat (Drug)
Cohort 1
Experimental
Effect of resmetirom on pharmacokinetics of denifanstat
干预措施: Resmetirom (Drug)
结局指标
主要结局
Area under the concentration-time curve during a dosing interval (tau) at steady state (AUC0-tau)
时间窗: 7 days
Maximum observed concentration at steady-state (Cmax,ss)
时间窗: 7 days
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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