Open-Label, Fixed-Sequence 3-Period Study to Determine the Effects of Repeated Oral Dosing of AQX-1125 on the Pharamacokinetics, Safety and Tolerability of a Combination Oral Contraceptive in Healthy Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Maximum observed plasma concentration (Cmax) of COC taken with AQX-1125
研究概览
简要总结
This is an open-label, fixed sequence, 4 cycle, drug-drug interaction (DDI) study of AQX-1125 in healthy female subjects on combination oral contraceptives (COC).
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 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
- •Aged 18-45 years, inclusive, at time of signing Informed Consent
- •Adult females of child bearing potential, who are non-pregnant and non-lactating, and must agree to use adequate additional contraception from the start of Treatment Period A until 90 days after the last dose of AQX-1125
- •BMI 18.0 - 35.0 kg/m2
- •Good physical and mental health based on medical history, physical examination, clinical laboratory, ECG and vital signs, as judged by the investigator
排除标准
- •Previous participation in the current study
- •Any clinically significant history of breakthrough bleeding
- •Using tobacco or other nicotine containing products within 12 months prior to the first study-specific COC-cycle intake
- •History of alcohol abuse or drug addiction
- •Positive drug and alcohol screen at screening and (each) admission to the clinical research center
- •Average intake of more than 24 units of alcohol per week
- •Positive screen for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies
- •Participation in a drug study within 30 days prior to screening. Participation in more than 2 other drug studies in the 10 months prior to (the first) drug administration in the current study
- •Donation or loss of more than 100 mL of blood within 60 days prior to the start of Treatment Period A, on Day
- •Donation or loss of more than 1.0 liters of blood in the 10 months prior to the start of Treatment Period A, on Day 1
- •Significant and/or acute illness within 5 days prior to Day 1 in Treatment Period A, that may impact safety assessments, in the opinion of the investigator
- •Unsuitable veins for blood sampling
研究组 & 干预措施
Pre-Treatment, Treatment Cycles A & B
Pre-Treatment: Two cycles of a combined oral contraceptive (COC) taken orally once daily for 21 days followed by 7 COC-free days.
Treatment Period A: COC containing taken orally once daily for 21 days followed by 7 COC-free days.
Treatment Period B: COC taken orally once daily for 21 days, with once daily oral 200 mg AQX-1125 (2 x 100 mg tablets) co-administered from Day 13 to 21, followed by 7 COC-free days
干预措施: AQX-1125 (Drug)
Pre-Treatment, Treatment Cycles A & B
Pre-Treatment: Two cycles of a combined oral contraceptive (COC) taken orally once daily for 21 days followed by 7 COC-free days.
Treatment Period A: COC containing taken orally once daily for 21 days followed by 7 COC-free days.
Treatment Period B: COC taken orally once daily for 21 days, with once daily oral 200 mg AQX-1125 (2 x 100 mg tablets) co-administered from Day 13 to 21, followed by 7 COC-free days
干预措施: Combined Oral Contraceptive (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax) of COC taken with AQX-1125
时间窗: 8 Weeks (from start of treatment period A to completion of treatment period B)
To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC
Time to attain maximum observed plasma concentration (tmax) of COC taken with AQX-1125
时间窗: 8 Weeks (from start of treatment period A to completion of treatment period B)
To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC
Area under the plasma concentration-time curve up to 24 hours (AUC0-24) of COC taken with AQX-1125
时间窗: 8 Weeks (from start of treatment period A to completion of treatment period B)
To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC
Terminal elimination rate constant (Kel) of COC taken with AQX-1125
时间窗: 8 Weeks (from start of treatment period A to completion of treatment period B)
To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC
Terminal elimination half-life (t1/2) of COC taken with AQX-1125
时间窗: 8 Weeks (from start of treatment period A to completion of treatment period B)
To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC
次要结局
- Safety and tolerability of AQX-1125 200 mg qd administered with the COC(16 weeks (from start of pre-treatment cycle 1 to completion of treatment period B))
- Maximum observed plasma concentration (Cmax) of AQX-1125 taken with COC(8 Weeks (from start of treatment period A to completion of treatment period B))
- Time to attain maximum observed plasma concentration (tmax) of AQX-1125 taken with COC(8 Weeks (from start of treatment period A to completion of treatment period B))
- Area under the plasma concentration-time curve up to 24 hours (AUC0-24) of AQX-1125 taken with COC(8 Weeks (from start of treatment period A to completion of treatment period B))
- Terminal elimination rate constant (Kel) of AQX-1125 taken with COC(8 Weeks (from start of treatment period A to completion of treatment period B))
- Terminal elimination half-life (t1/2) of AQX-1125 taken with COC(8 Weeks (from start of treatment period A to completion of treatment period B))