A Phase 1 Study to Evaluate the Pharmacokinetic Interaction Potential Between BIIB074 and an Oral Contraceptive Regimen in Healthy Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Maximum Observed Concentration (Cmax) for OC
研究概览
简要总结
The primary objective of this study is to evaluate the effect of multiple doses of a uridine diphosphate glucuronosyltransferases (UGT)-inducing oral contraceptive (OC) regimen (ethinyl estradiol and levonorgestrel) on the PK of BIIB074 at steady state; evaluate the effect of multiple doses of BIIB074 on the pharmacokinetics(PK) of an OC regimen (ethinyl estradiol and levonorgestrel) at steady state.
The secondary objective of this study is to evaluate the safety and tolerability of BIIB074 when administered alone and when coadministered with a UGT-inducing OC regimen containing ethinyl estradiol and levonorgestrel and to evaluate the effect of a UGT-inducing OC regimen (ethinyl estradiol and levonorgestrel) on the PK of the M13, M14, and M16 metabolites of BIIB074.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Must have a body mass index between 18 and 32 kg/m^2, inclusive.
- •Females of childbearing potential must practice effective non-hormonal contraception during the study and be willing and able to continue contraception for 5 weeks after their last dose of study treatment,
- •Must be in good health as determined by the Investigator, based on medical history and screening evaluations.
排除标准
- •History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
- •History of, or positive test result at Screening for, human immunodeficiency virus (HIV)
- •Clinically significant abnormal laboratory test values, as determined by the Investigator, at Screening or Day -1
- •Previous intolerance to OC medications
- •Other unspecified reasons that, in the opinion of the Investigator or Biogen, make the subject unsuitable for enrollment.
- •NOTE:Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
BIIB074 150 mg and Oral Contraceptive
Participants will receive BIIB074 in tablet form in 150 mg doses every 8 hours on prescription (TID) on days 1-7 and on days 26-32. OC will be taken in tablet form (ethinyl estradiol 30 micrograms and levonorgestrel 150 micrograms) once daily (QD) on days 12-32.
干预措施: BIIB074 (Drug)
BIIB074 150 mg and Oral Contraceptive
Participants will receive BIIB074 in tablet form in 150 mg doses every 8 hours on prescription (TID) on days 1-7 and on days 26-32. OC will be taken in tablet form (ethinyl estradiol 30 micrograms and levonorgestrel 150 micrograms) once daily (QD) on days 12-32.
干预措施: OC (ethinyl estradiol and levonorgestrel) (Drug)
结局指标
主要结局
Maximum Observed Concentration (Cmax) for OC
时间窗: Day 25, 32
Terminal Elimination Half-Life (t1/2) of OC
时间窗: Day 25, 32
Apparent Clearance (CL/F) for OC
时间窗: Day 25, 32
Apparent Volume of Distribution at Steady State (Vss/F) for OC
时间窗: Day 25, 32
Area Under the Concentration-Time Curve from Hour 0 to Hour 8 (AUC8) for BIIB074
时间窗: Day 7, 32
Time to Reach Maximum Observed Concentration (Tmax) for BIIB074
时间窗: Day 7, 32
Area Under the Concentration-Time Curve from Hour 0 to Hour 24 (AUC24) for OC
时间窗: Day 25, 32
Terminal Elimination Half-Life (t1/2) of BIIB074
时间窗: Day 7, 32
Maximum Observed Concentration (Cmax) for BIIB074
时间窗: Day 7, 32
Apparent Clearance (CL/F) for BIIB074
时间窗: Day 7, 32
Apparent Volume of Distribution at Steady State (Vss/F) for BIIB074
时间窗: Day 7, 32
Time to Maximum Observed Concentration (Tmax) for OC
时间窗: Day 25, 32
次要结局
- Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)(Approximately 71 days)
- Number of Participants with Abnormal Change from Baseline in Laboratory Parameters up to Day 33(Day 3, 7, 24, 28, 33)
- Number of Participants with Abnormal Change from Baseline in Hematology Panel up to Day 33(Day 3, 7, 24, 28, 33)
- Number of Participants with Abnormal Change from Baseline in Urinalysis Panel up to Day 33(Day 3, 7, 24, 28, 33)
- Number of Participants with Abnormal Change from Baseline in Vital Sign Measurements up to Day 33(Day 1, 3, 7, 12, 24, 25, 26, 28, 33)
- Number of Participants with Abnormal Change from Baseline in Electrocardiogram (ECG) up to Day 33(Day 1, 3, 7, 12, 25, 26, 28, 33)
- Number of Participants with Abnormal Change from Baseline in Physical Examination up to Day 33(Day -1, 33)
- AUC 8 of BIIB074 Metabolites M13, M14, and M16(Day 7, 32)
- Cmax for BIIB074 Metabolites M13, M14, and M16(Day 7, 32)
- Tmax for BIIB074 Metabolites M13, M14, and M16(Day 7, 32)
- Terminal Elimination Half-Life (T 1/2) for BIIB074 Metabolites M13, M14, and M16(Day 7, 32)
- Metabolite-to-Parent Ratio in AUC (MRauc) for BIIB074 Metabolites M13, M14, and M16(Day 7, 32)
- Number of Participants with Abnormal Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Assessments(Day 7, 12, 24, 33, and once between Day 39-42)