NCT00504816已完成1 期
An Open Label, Single-sequence, Repeat-dose Study to Investigate the Effects of GSK189075 on the Pharmacokinetics of an Oral Contraceptive Pill When Coadministered to Healthy Female Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Oral contraceptive pill (OC) drug levels
研究概览
简要总结
The purpose of this research study is to demonstrate a lack of effect of multiple doses of GSK189075 on the PK of an oral contraceptive pill in healthy female subjects. To estimate the effects of GSK189075 on hormonal levels and on birth control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy, non-smoking menstruating female age 18 to 45 years old, inclusive.
- •able to take a specific oral contraceptive & KG
- •female unable to have any more children, still has ovaries and uterus, and has a negative pregnancy test.
- •female who can have children and who has regular periods and are willing to use an oral contraceptive pill and/or have a sterile partner.
排除标准
- •pregnant or a nursing female.
- •female subject able to have children of who is unwilling or unable to use an appropriate method of birth control at least 2 weeks prior to first dose of study drug until completion of the Follow-up visit.
- •Have suffered with certain infection within 4 weeks prior to the first dose of study drug
研究组 & 干预措施
Brevicon
Other
Oral contraceptive used to determine pharmacokinetics when given with GSK189075 to look for interaction.
干预措施: GSK189075 (Drug)
GSK189075
Experimental
Given in conjunction with Brevicon to see if GSK189075 interfered with Brevicon drug levels.
干预措施: Brevicon (Drug)
结局指标
主要结局
Oral contraceptive pill (OC) drug levels
时间窗: over 24h starting on Day 14
blood hormone levels
时间窗: on Days 1, 11-14, & 21 of Periods 1 (OC alone) & 3 (OC plus GSK study drug). Period 2 is GSK drug study alone.
次要结局
- Adverse events(all visits after study drug)
- ECGs, Clinical laboratory tests(screening & follow-up)
- vital signs(screening;Day 13, Period 1 & 3; Follow-up)
研究者
研究点 (1)
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