NCT03792971已完成1 期
Phase 1, Open-label, One-arm, Fixed-sequence Study to Evaluate the Effects of 90 mg Intravenous Infusions of GC4419 on the Single Dose Pharmacokinetics of Dextromethorphan in Healthy Adult Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Pharmacokinetic (PK) profile for dextromethorphan (DM) (in plasma): AUC0-inf
研究概览
简要总结
This will be a single center, phase 1, open-label, fixed-sequence study under fasting conditions to evaluate the effect of 90 mg intravenous (IV) infusions of GC4419 on the single-dose pharmacokinetic (PK) of dextromethorphan (DM) capsules liquid filled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male or female, non-smoker, ≥ 18 and ≤ 55 years of age, with BMI > 18.5 and < 30.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
- •Healthy as defined by:
- •the absence of clinically significant illness and surgery within 4 weeks prior to dosing.
- •the absence of clinically significant history of neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
- •Females of childbearing potential must be willing to use acceptable contraceptive method throughout the study and for 30 days after the last study drug administration:
- •Male subjects must be willing to use acceptable contraceptive method from the first dosing until at least 90 days after the last study drug administration:
- •Male subjects (including men who have had vasectomies) with a pregnant partner must agree to use a condom from the first dosing until at least 90 days after the last study drug administration.
- •Male subjects must be willing not to donate sperm until 90 days following the last study drug administration.
- •Capable of consent.
- •Consent to perform genotyping for CYP2D6.
排除标准
- •Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results
- •Positive urine drug screen or urine cotinine test at screening.
- •History of allergic reactions to GC4419, DM, or other related drugs.
- •Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to the first DM administration.
- •Poor CYP2D6 metabolizers as determined by genetic testing.
- •Positive pregnancy test at screening.
- •Any reason which, in the opinion of the Principal Investigator, would prevent the subject from participating in the study.
- •Clinically significant ECG abnormalities or vital sign abnormalities
- •History of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening visit
- •History of significant drug abuse
- •Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.
- •Use of medication other than hormonal contraceptives and topical products without significant systemic absorption:
- •Donation of plasma within 7 days prior to dosing.
- •Breast-feeding subject.
研究组 & 干预措施
Fixed Sequence
Experimental
干预措施: Dextromethorphan HBr (Drug)
Fixed Sequence
Experimental
干预措施: GC4419 (Drug)
结局指标
主要结局
Pharmacokinetic (PK) profile for dextromethorphan (DM) (in plasma): AUC0-inf
时间窗: Pre-dose on Day 1, and at 0.5, 1 (immediately prior to the end of GC4419 infusion), 2, 3, 4, 6, 8, 12, and 24 hours after the start of infusion
Pharmacokinetic (PK) profile for dextromethorphan (DM) (in plasma): AUC0-t
时间窗: Pre-dose on Day 1, and at 0.5, 1 (immediately prior to the end of GC4419 infusion), 2, 3, 4, 6, 8, 12, and 24 hours after the start of infusion
Pharmacokinetic (PK) profile for dextromethorphan (DM) (in plasma): Cmax
时间窗: Pre-dose on Day 1, and at 0.5, 1 (immediately prior to the end of GC4419 infusion), 2, 3, 4, 6, 8, 12, and 24 hours after the start of infusion
次要结局
未报告次要终点
研究者
研究点 (1)
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