Double-Blind, Randomized, Placebo-Controlled, Multi-Center Trial to Assess Safety, Tolerability, and PK of the Anti-Orthopoxvirus Compound ST-246 When Administered as a Single Daily Oral Dose for 14 Days in Volunteers in the Fed State
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 6
- 主要终点
- Number of Study Participants Who Tolerated a Single Daily Oral ST-246 Dose as Determined by Safety Parameter Changes According to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table.
研究概览
简要总结
The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of two clinical doses of the anti-orthopoxvirus drug, ST-246, administered as a single daily oral dose for 14 days to healthy, fed volunteers. The results of this trial determine which dose will be used in expanded pivotal safety trials.
详细描述
This study is a Phase II, double-blind, randomized, placebo-controlled, multi-center (3 sites) trial to assess the safety, tolerability, and pharmacokinetics of 400 mg and 600 mg Form I ST-246 when administered as a single daily oral dose for 14 days to 107 healthy, fed volunteers between 18 and 74 years of age. Safety parameters included adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, and urinalysis) and electrocardiograms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 - 75 yrs
- •Healthy volunteer
- •Ability to consent
- •Available for clinical follow-up for study
- •Not taking other medications
- •Adequate venous access
- •Using adequate birth control; negative pregnancy test
- •Able and willing to avoid alcohol for screening and study duration
排除标准
- •Inability to swallow study medication
- •Pregnant or breast-feeding
- •Medical condition, e.g., asthma, hypertension, angioedema, traumatic brain injury other than concussion, bleeding disorder, blood dyscrasia, idiopathic seizures, cardiac disease that limits activity, diabetes, active malignancy, Hepatitis B or C, HIV or AIDS, chronic microbial infection,
- •History of drug allergy that contraindicates study participation
- •Medical, psychiatric, social, occupational or other reason that jeopardizes the safety/rights of participant or renders he/she unable to comply with the protocol (including drug or alcohol abuse, or homelessness)
- •Clinically abnormal ECG
- •Has or will participate in a clinical trial or experimental treatment within 30 days of, or during, the study
- •Cannot or will not do physical exercise 24 hrs before and after PK days
- •Will not consume grapefruit/grapefruit juice during study
- •Vaccination within 2 wks of screening, or planned before Day 42 of study
- •Treatment with prednisone or equivalent immunosuppressant/modulatory drug <3 mths before screening
- •Clinically significant physical exam and lab results <2weeks from 1st study drug dose
研究组 & 干预措施
ST-246 400 mg
ST-246 400mg (2 x 200 mg Capsules) Orally Once Daily for 14 days
干预措施: ST-246 400 mg (Drug)
ST-246 600 mg
ST-246 600 mg (3 x 200 mg Capsules) Orally Once Daily for 14 days
干预措施: ST-246 600 mg (Drug)
Placebo
Matching Placebo capsules, Orally Once Daily for 14 days
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Study Participants Who Tolerated a Single Daily Oral ST-246 Dose as Determined by Safety Parameter Changes According to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table.
时间窗: Days 1 to 14; then 24, 48, 72, 96 and 120 hours and 4 weeks after final dose
Subjects were administered a single, daily oral dose of ST-246 (400 or 600 mg)and changes in safety parameteres were monitored. Safety parameters included adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, and urinalysis) and electrocardiograms. The DAIDS AE grading table is a list of common terms and severity (intensity) of parameters used to describe adverse events occurring in NIAID-sponsored clinical studies/trials.
次要结局
- Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax(Day 14 post-dose)
- Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax(Day 14 post-dose)
- Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau(Day 14 post-dose)
- Evaluation of Pharmacokinetic Parameters to Assess Interventions: t½(Day 14 post-dose)
- Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax(Day 1 post-dose)
- Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax(Day 1 post-dose)
- Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau(Day 1 post-dose)