A Randomised, Double-blind, Placebo Controlled, Dose Ascending, Parallel Group Study to Evaluate the Safety, Tolerability, Steady State Pharmacokinetics and Pharmacodynamics of SB-656933-AAA Following Repeated Doses in Healthy Adult Subjects. The Pharmacokinetic Interaction Between Repeated Doses of SB-656933-AAA and Single Dose of Simvastatin Will Also be Assessed
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Assess safety of SB-656933 after repeat doses.
研究概览
简要总结
To assess safety of SB-656933 following repeat dosing for 14 days.
详细描述
A randomised, double-blind, placebo controlled, dose ascending, parallel group study to evaluate the safety, tolerability, steady state pharmacokinetics and pharmacodynamics of SB-656933-AAA following repeated doses in healthy adult subjects. The pharmacokinetic interaction between repeated doses of SB-656933-AAA and single dose of simvastatin will also be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy adult female, aged 18-65 years.
- •Female must not be able to have children.
- •Non-smoking for the last 6 months.
排除标准
- •Any serious medical condition.
- •Hepatitis B or C and/or HIV positive.
- •Currently on HRT, or other medication except paracetamol.
- •Body Mass Index >30.
研究组 & 干预措施
Cohort 2
Subjects will be administered 40 mg simvastatin on day 1 followed by a washout period of two days. From day 3, the subjects will receive 50 mg of SB-656933-AAA once daily or matching placebo once daily for 14 days. On day 17, subjects will be administered 40 mg simvastatin along with SB-656933-AAA to assess statin interaction.
干预措施: Matching placebo (Drug)
Cohort 1
Subjects in Cohort 1 will receive 20 milligrams (mg) of SB-656933-AAA once daily or matching placebo once daily for 14 days.
干预措施: SB-656933-AAA (Drug)
Cohort 1
Subjects in Cohort 1 will receive 20 milligrams (mg) of SB-656933-AAA once daily or matching placebo once daily for 14 days.
干预措施: Matching placebo (Drug)
Cohort 2
Subjects will be administered 40 mg simvastatin on day 1 followed by a washout period of two days. From day 3, the subjects will receive 50 mg of SB-656933-AAA once daily or matching placebo once daily for 14 days. On day 17, subjects will be administered 40 mg simvastatin along with SB-656933-AAA to assess statin interaction.
干预措施: SB-656933-AAA (Drug)
Cohort 2
Subjects will be administered 40 mg simvastatin on day 1 followed by a washout period of two days. From day 3, the subjects will receive 50 mg of SB-656933-AAA once daily or matching placebo once daily for 14 days. On day 17, subjects will be administered 40 mg simvastatin along with SB-656933-AAA to assess statin interaction.
干预措施: Simvastatin (Drug)
Cohort 3
Subjects will be administered 100 mg SB-656933-AAA/ day or matching placebo for 14 days. Dosing will initiate after cohort I and II have completed dosing.
干预措施: SB-656933-AAA (Drug)
Cohort 3
Subjects will be administered 100 mg SB-656933-AAA/ day or matching placebo for 14 days. Dosing will initiate after cohort I and II have completed dosing.
干预措施: Matching placebo (Drug)
结局指标
主要结局
Assess safety of SB-656933 after repeat doses.
时间窗: after repeat doses
次要结局
- Investigate concentrations of SB-656933 in the body and how long it remains in the body over 14 days of repeat dosing.(14 days of repeat dosing.)