A Phase 1, Single-Blind, Randomized, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of GS-6615 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Safety and tolerability of GS-6615
研究概览
简要总结
This is a phase 1, single-blind, randomized, placebo-controlled, multiple ascending dose study aimed to assess the safety, tolerability, and pharmacokinetics of GS-6615 in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Weight of at least 50 kg with body mass index (BMI) between 18 and 30 kg/m2
- •Female subjects must be of non-childbearing potential as defined per the protocol
- •Male subjects with female partners of childbearing potential must be using protocol acceptable methods of contraception
- •Willing and able to comply with the requirements of the protocol and directions
- •Willing to avoid consumption of grapefruit, grapefruit juice and Seville oranges
- •Willing to avoid consumption of nicotine (including nicotine gum) and alcoholic beverages
排除标准
- •Ongoing or history of any medical or surgical condition that, in the judgment of the Investigator, might jeopardize the subject's safety or interfere with the study objectives
- •History of meningitis or encephalitis, seizures, migraines, tremors, myoclonic jerks, sleep disorder, anxiety, syncope, head injuries or a family history of seizures
- •Any abnormal ECG findings, abnormal laboratory value, or physical examination findings at Screening judged to be clinically significant
- •Any abnormal neurological examination findings at Screening that is judged as clinically significant
- •Hemoglobin < 12 g/dL
- •Serology test positive for HIV, or hepatitis B or C
- •Positive urine drug test (including cotinine or ethanol)
- •Use of systemic prescription medications or over the counter (OTC) medication, including multivitamins, and dietary and herbal supplement
- •Use of any experimental or investigational drug or device within 30 days
- •Female subjects who are of childbearing potential, pregnant or lactating
- •Donation or loss of blood within 8 weeks and/or donation of plasma within 7 days
- •History of drug or alcohol abuse
- •Psychosocial or addictive disorders
研究组 & 干预措施
Cohort 1
Randomized to 6 mg once daily (Days 1-7) followed by 3 mg once daily (Days 8-21) of GS-6615 or matching placebo
干预措施: GS-6615 (Drug)
Cohort 1
Randomized to 6 mg once daily (Days 1-7) followed by 3 mg once daily (Days 8-21) of GS-6615 or matching placebo
干预措施: Placebo (Drug)
Cohort 2
Randomized to 12 mg once daily (Days 1-7) followed by 6 mg once daily (Days 8-21) of GS-6615 or matching placebo
干预措施: GS-6615 (Drug)
Cohort 2
Randomized to 12 mg once daily (Days 1-7) followed by 6 mg once daily (Days 8-21) of GS-6615 or matching placebo
干预措施: Placebo (Drug)
Cohort 3
Randomized to 20 mg once daily (Days 1-7) followed by 9 mg once daily (Days 8-21) of GS-6615 or matching placebo
干预措施: GS-6615 (Drug)
Cohort 3
Randomized to 20 mg once daily (Days 1-7) followed by 9 mg once daily (Days 8-21) of GS-6615 or matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability of GS-6615
时间窗: Up to 65 days
The primary outcome measure is the safety and tolerability of GS-6615 including neurological findings, adverse events, clinical laboratory tests, vital signs and ECG data (PR, RR, QRS, QT, and QTc \[Fridericia\] interval).
Pharmacokinetic (PK) profile of GS-6615
时间窗: Up to 65 days
The primary outcome measure is the PK profile of GS-6615 which will be measured with Cmax, Tmax, AUCtau, AUC0-∞, T1/2, CL/F, VSS/F, and R.
次要结局
未报告次要终点