ACTRN12618000883213已完成1 期
Study assessing the single and multiple dose, safety and tolerability of an intravaginal ointment containing R131 in healthy female volunteers.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 20 Years 至 45 Years（—）
- 性别
- Female
入选标准
- •a)Women, 20 to 45 years old, with an intact uterus and vagina.
- •b)Generally, in good health with no clinically significant pulmonary, cardiac, gastroenterological, pancreatic, neurologic, renal, musculoskeletal, rheumatologic, metabolic, neoplastic, or endocrine disease.
- •c)BMI of greater than or equal to 19 and less than or equal to 30.0
- •d)ECG and vital signs within normal ranges
- •e)Agree to no Alcohol from 48 hours prior to dosing in period 1 until 7 days after receiving the final dose in period 2.
- •f)Abstain from food or beverages containing grapefruit, starfruit, pomegranate, pineapple, or pomelo for the entire study
- •g)Able and willing to abstain from sexual intercourse +/– 6 hours around dosing within Periods 1 and 2
- •h)Able and willing to use stringent methods of contraception after required abstinence period through to Day 29 (7 days after receiving the final dose in period 2), including the use of a non-latex condom (for partner protection) and a second acceptable contraception method.
- •i)Agree to abstain from activities such as vaginal douching or insertion of any vaginal products other than the study drug for at least 48 hours prior to enrolment and throughout the study.
- •j)Negative Pap test at screening or within 3 years of enrolment and no history of cervical intraepithelial lesions within the previous 3 years
- •k)Able and willing to return to the clinic for all study procedures.
- •l)Able and willing to provide informed consent.
排除标准
- •a)Women who are pregnant, plan to become pregnant in the next 3 months, or lactating females.
- •b)History of genital herpes with >3 outbreaks per year, or active non-HPV vaginal infection
- •c)Positive result for Hep B, Hep C or HIV.
- •d)Have an active pelvic infection (positive urine screen for gonorrhoea or chlamydial infection, positive test and symptoms for bacterial vaginosis, candida vaginitis or trichomonal vaginitis)
- •e)Current or recent abnormal vaginal discharge and /or abnormal vaginal bleeding, within the 3 months prior to randomization as accessed by Investigator.
- •f)Had an abortion or miscarriage within the 3 months prior to randomization
- •g)Currently taking any of the following medications: oral corticosteroids, inhaled salmeterol and fluticasone; immunomodulatory treatments, over the counter (OTC) intra-vaginal preparation, or any prescription that in the opinion of the Investigator could interfere with the interpretation of the results.
- •h)Currently taking any of the medications listed here - Alfuzosin, Amiodarone, dronedarone, Ranolazine, Fusidic Acid, Colchicine, Astemizole, terfenadine, Lurasidone, Pimozide, Quetiapine, Dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cisapride, Lovastatin, simvastatin, Avanafil, Sildenafil, Vardenafil, Oral midazolam, triazolam, St. John's wort.
- •i)Recent history (within previous 3 months) of Stevens-Johnson syndrome, erythema multiforme, urticaria, angioedema, deep vein thrombosis, tinnitus, vertigo, blood glucose disorders, pancreatitis, haemophilia.
- •j)Hypersensitivity to any component of R131 vaginal ointment excipients
- •k)Participation in any clinical study with an experimental medication or device within 30 days or 5 half-lives (whichever is longer) of enrolment.
- •l)Current alcohol or substance abuse as assessed by the Investigator.
- •m)An employee or first degree family member of an employee, the Sponsor, the CRO or study site.
- •n)Not having a GP
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