NCT02474589已完成3 期
An Expanded Double-Blind, Placebo Controlled, Multicenter Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti Orthopoxvirus Compound Tecovirimat When Administered Orally for 14 Days in Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 449
- 试验地点
- 20
- 主要终点
- To Determine the Number of Participants With Adverse Events
研究概览
简要总结
Multicenter, double-blind, placebo controlled, Phase 3 study to determine the safety and tolerability of oral tecovirimat, an anti orthopoxvirus compound, in subjects.
详细描述
Pharmacokinetics and safety and tolerability data will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 80 years old, inclusive
- •Available for clinical follow-up for the duration of the study
- •Able and willing to give informed consent
- •In good general health without clinically significant medical history; not have been hospitalized for a chronic medical condition for the last 2 years
- •Able to comply with dietary requirements throughout the study drug dosing period
- •Adequate venous access for those individuals participating in PK testing
- •PE and laboratory results without clinically significant findings within the 14 days before receipt of study drug
- •Agree not to drink alcohol from the beginning of the Screening Period through the completion of the Day 28 Follow up Visit
- •Agree not to use any nicotine products, including electronic vapor cigarettes, nicotine patches or nicotine gum for at least 30 days before the Day 1 Visit and through completion of the Day 15 Dosing complete Visit
- •Agree not to consume caffeine during all study visits, including overnight stays if participating in PK subset
- •Agree not to receive any immunizations/vaccinations
- •Agree not to take herbal products
- •Able and willing to refrain from taking any prescriptions and nonprescription medications with exceptions
- •For women of childbearing potential, negative serum and urine pregnancy testing
- •If male, agree not to donate sperm
- •Meet 1 of the following criteria: The subject or their partner has undergone surgical sterilization; the subject is postmenopausal; the subject agrees to be abstinent; the subject agrees to consistently use a method of approved birth control.
排除标准
- •Pregnant or breast-feeding or planning pregnancy
- •Have a history of any clinically significant conditions
- •Have any limitation of activity related to cardiac disease
- •Have a bleeding disorder diagnosed by a doctor, or a history of significant bruising or bleeding with intramuscular injections or blood draws
- •Currently using certain medications
- •Have a malignancy that is active or a treated malignancy for which there is no reasonable assurance of sustained cure, or malignancy that is likely to recur during the study
- •Have a history of seizure
- •Have a clinically significant blood dyscrasia
- •Have a history of drug allergy that contraindicates participation in the trial
- •Have a medical, psychiatric, or social condition or any occupational reason, or other responsibility that in the judgment of the investigator would render the subject unable to comply with the protocol
- •Have an inability to swallow medication
- •Have a clinically significant abnormal ECG
- •Have participated in a clinical trials within 30 days of study entry or planning to participate in any experimental treatment study during the study period
- •Have a history or current drug or alcohol abuse
- •Have received immunizations/vaccines
- •Have a current clinically significant acute bacterial, fungal, or mycobacterial infection requiring administration of systemic antibiotics
- •Have known chronic bacterial, mycobacterial, fungal, parasitic, or protozoal infection with the exception of clinically significant dermal infections
- •Have known hepatitis B or C infection, or positive test result
- •Have known HIV infection or AIDS or a positive test for HIV
- •Have a current clinically significant viral infection
- •Have known clinically significant chronic viral infection
- •have received treatment with greater than 20 mg prednisone or equivalent dose or any immunosuppressant or immunomodulary medication
- •Have abnormal laboratory testing during screening
- •Have a greater than or equal than 20% risk of suffering a major cardiovascular event
- •Have been previously enrolled in this or any clinical trial involving tecovirimat
研究组 & 干预措施
Active
Active Comparator
600 mg tecovirimat capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects
干预措施: tecovirimat (Drug)
Placebo
Placebo Comparator
matching placebo capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects
干预措施: Placebo (Other)
结局指标
主要结局
To Determine the Number of Participants With Adverse Events
时间窗: 45 days
To determine the safety and tolerability of oral tecovirimat
次要结局
未报告次要终点
研究者
研究点 (20)
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