ISRCTN13846827已完成1 期
A phase 1, single-center, open label, up to two-part, single dose study to evaluate the pharmacokinetics, safety, tolerability, effect of refrigerated storage on taste of tecovirimat pediatric formulation prototype(s) for oral suspension in healthy adult subjects
Siga Technologies (United States)0 个研究点目标入组 12 人开始时间: 2021年7月28日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Healthy males and female subjects between 18 and 50 years of age, inclusive.
- •2. Female subjects of childbearing potential must not be pregnant, lactating, or planning to become pregnant before 3 months after the last dose of study drug, and have a negative urine pregnancy test at screening and admission. Female subjects of childbearing potential (including perimenopausal women who have had a menstrual bleeding within 1 year) must use appropriate birth control from 30 days before study drug administration until 35 days after last IMP administration. Women are considered to be not of childbearing potential if they have been surgically sterilized (documented hysterectomy or tubal ligation/occlusion) or are postmenopausal (had no menses for 12 months without an alternative medical cause and a serum follicle stimulating hormone [FSH] concentration =40 IU/L)
- •3. Male subjects must agree to not donate sperm from the first dose of study drug through 95 days after the last dose of study drug.
- •4. Subject has a body mass index between 18.0 and 32.0 kg/m2, inclusive, at screening
- •5. Subject is considered by the investigator to be in good general health as determined by medical history, clinical laboratory results, vital sign measurements, 12 lead electrocardiogram (ECG) results, and physical examination findings at screening
- •6. Subject agrees to comply with all protocol requirements
- •7. Subject is able to provide written informed consent
排除标准
- •1. Subject has received any vaccination within 28 days prior to Day 1 or plans to receive a vaccination at any time during the study until the follow-up phone call.
- •2. Subject has received treatment in another clinical study of an investigational drug (or medical device) within 90 days before the first dose of study drug.
- •3. Subjects who have previously been administered IMP in this study. Subjects who have taken part in Part 1 are not permitted to take part in Part 2.
- •4. Subject has any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract, including removal of parts of stomach, bowel, liver, gallbladder, or pancreas).
- •5. Subject has evidence or history of clinically significant allergies (except for untreated, asymptomatic, seasonal allergies at time of the first dose of study drug), haematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, renal, dermatological, or neurological disease. Exceptions to these criteria (e.g., stable, mild joint disease unassociated with collagen vascular disease) may be made following discussions with the medical monitor.
- •6. Subject reports lactose intolerance.
- •7. Subject has a history of cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or risk factors for torsades de pointes (e.g., heart failure, hypokalaemia).
- •8. Subject has a family history of sudden cardiac death not clearly due to acute myocardial infarction.
- •9. Subject has a seizure disorder or history of seizures (does not include childhood febrile seizures) or family history of idiopathic seizures.
- •10. Subject has a history of drug or alcohol abuse or dependency within the last 2 years before screening.
- •11. Regular alcohol consumption >14 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type).
- •12. Subject has a current or recent (<30 days before screening) history of clinically significant bacterial, fungal, or mycobacterial infection.
- •13. Subject has a current clinically significant viral infection.
- •14. Subject has used any prescription (excluding hormonal birth control or hormone replacement therapy [HRT]) or over the counter medication (including herbal or nutritional supplements, excluding up to 4 g per day paracetamol) within 14 days before the first dose of study drug.
- •15. Subject demonstrates long-term use (=14 consecutive days) of glucocorticoids including oral or parenteral prednisone or equivalent (>20 mg total dose per day) or high dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 1 month. (Low dose [=800 µg/day of beclomethasone dipropionate or equivalent] inhaled and topical steroids are allowed).
- •16. Subject has donated >450 mL blood or blood components within 30 days before the first dose of study drug. The investigator should instruct subjects who participate in this study to not donate blood or blood components for 90 days following the last dose of study drug.
- •17. Subject is a smoker or has used nicotine or nicotine-containing products (e.g., cigarettes, electronic vapor cigarettes, cigars, chewing tobacco, snuff, nicotine patches, or nicotine gum) within 6 months before the first dose of study drug.
- •18. Subject has consumed grapefruit or grapefruit juice, pomegranate or pomegranate juice, pomelo fruits or pomelo juice, or alcohol-, caffeine-, or xanthine-containing products (e.g., tea, coffee, ch
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