NCT03783897已完成1 期
A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effects of EDP 305 on the Pharmacokinetics of a Combined Oral Contraceptive in Healthy Adult Female Subjects
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
- 43
- 试验地点
- 1
- 主要终点
- Cmax for OC with and without coadministration with EDP-305
研究概览
简要总结
A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effects of EDP 305 on the Pharmacokinetics of a Combined Oral Contraceptive in Healthy Adult Female Subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Females of childbearing potential, 18 to 45 years of age, inclusive. Follicle-stimulating hormone levels may be used to confirm premenopausal status, including females who have had a hysterectomy with ovaries still intact. Women who otherwise meet inclusion criteria and who have had tubal ligation, tubal occlusion, or bilateral salpingectomy will be allowed.
- •Body mass index between 18.0 and 32.0 kg/m2, inclusive.
- •In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations at Screening and Day -1 of the Lead-in Period
- •Must not be pregnant or lactating, and must agree to use contraception
- •Subjects must have documentation of normal results of up-to-date cervical cancer screening as specified in the American College of Obstetricians and Gynecologists guidelines:
- •Women aged < 21 years: no documentation required
- •Women aged 21 to 29: normal Pap smear test result within previous 3 years
- •Women aged 30 to 45: normal Pap smear test result and negative high-risk human papilloma virus test within previous 5 years, OR normal Pap smear test result within previous 3 years If documented results are not available at Screening, the subject must provide documentation of normal results prior to Day -1 of the Lead-in Period.
- •Able to comprehend and willing to sign an ICF.
- •Willing and able to adhere to assessments, prohibitions, and restrictions as described in this protocol.
排除标准
- •Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- •Are pregnant, breastfeeding, or are planning to conceive during the study.
- •Have been administered injectable contraceptives within 12 months prior to Day -1 of the Lead in Period, or had exposure to a hormonal intrauterine device or topical controlled delivery contraceptives (patch) within 3 months prior to Day -1 of the Lead-in Period.
研究组 & 干预措施
EDP-305 and Oral Contraceptive
Experimental
干预措施: Oral Contraceptive (Drug)
EDP-305 and Oral Contraceptive
Experimental
干预措施: EDP-305 (Drug)
结局指标
主要结局
Cmax for OC with and without coadministration with EDP-305
时间窗: Day 21 (cycle 2 and cycle 3)
Area under the plasma concentration-time (AUC0-τ) curve for OC with and without coadministration with EDP-305
时间窗: Day 21 (cycle 2 and cycle 3)
次要结局
- Safety measured by adverse events(Approximately 91 days)
- Area under the plasma concentration-time (AUC0-τ) curve for EDP-305 when coadministration with OC(Days 14, 20-22 (cycle 3))
- Cmax for EDP-305 when coadministration with OC(Days 14, 20-22 (cycle 3))
研究者
研究点 (1)
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