An Open-label Trial Investigating the Pharmacokinetics of FE 999049 Given as a Single Subcutaneous Dose in Gonadotropin Down-regulated Healthy Chinese Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Terminal Elimination Half-life (t½)
研究概览
简要总结
FE 999049 is a gonadotropin preparation containing recombinant human follicle stimulating hormone (rhFSH) under development by Ferring Pharmaceuticals. It is intended for controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle. In previous trials the exposure to and dose proportionality of FE 999049 in a clinically relevant dose range in Caucasian and Japanese healthy women have been shown to be very similar. This is a trial in healthy Chinese women investigating the pharmacokinetics, safety, and tolerability of a single subcutaneous dose of FE 999049.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female of Chinese origin, with two ethnic Chinese parents and four ethnic Chinese grandparents 21-40 years of age (both inclusive)
- •Willing to stop using combined oral contraceptives (COC) in relation to the first DECAPEPTYL Depot administration on Day -28
- •Agrees to use a double barrier method of contraception between Day -63 and Day 28, if not abstinent. A double barrier method of contraception should also be used after Day 28 until menses resumes or until another contraceptive method has been established
- •Normal menstrual cycles with a range of 24-35 days in the absence of oral contraceptives
- •Serum FSH less than equal to (≤)5 IU/L on Day -3 and Day -1
- •Body mass index (BMI) of 18.5 -25 kg/m^2 (both inclusive)
- •Negative serology for human immunodeficiency virus (HIV) antibody, hepatitis B (surface antigen), hepatitis C antibody, and syphilis bacteria
- •Healthy according to medical history, physical examination, gynaecological examination, ECG, blood pressure, and laboratory profile of blood and urine
- •Negative urine drug screen and alcohol breath test at screening and on Day -1
- •Non-smoker or light smoker (≤ 5 cigarettes/day) for at least 6 months prior to trial
排除标准
- •Presence or a history of clinically significant diseases of the renal, hepatic, gastrointestinal, cardiovascular, or musculoskeletal systems, or presence or history of clinically significant reproductive, psychiatric, immunological, endocrine or metabolic diseases
- •Cancer within the last 5 years except for adequately managed basal cell carcinoma and squamous cell carcinoma of the skin
- •Pregnancy or breastfeeding
- •Current or a history of endocrine abnormalities such as hyperprolactinaemia, polycystic ovary syndrome or other ovarian dysfunction, tumours of the pituitary gland or hypothalamus, thyroid or adrenal disease
- •Clinically significant findings on the trans-vaginal ultrasound, cytology, gynaecological or breast examination at screening or on Day -1 including ovarian cysts or tumours of the ovaries or uterus
- •Contraindications for the use of gonadotropins and gonadotropin-releasing hormone (GnRH) agonists
- •Previously treated with gonadotropins within the last 6 months prior to screening
- •History within the last two years or current abuse of alcohol or drugs
- •Presence or history of severe allergy or anaphylactic reactions
- •Intake of prescribed medication, over-the-counter (OTC) medication, or herbal medicines, with the exceptions of COC, cromoglycate, and paracetamol according to the labelling, within 2 weeks or 5 half-lives of the drug, whichever is longer, prior to first dose of DECAPEPTYL Depot. Topical treatments of bacterial or fungal infection are allowed if stopped before first dose of IMP
- •Intake of any non-registered investigational drug within the last 12 weeks preceding screening, or longer if judged by the investigator to possibly influence the outcome of the current trial
- •High daily consumption of caffeine-containing beverages (e.g. more than five cups of coffee or equivalent) with a risk of withdrawal symptoms arising during the trial that may confound the safety evaluation
- •Blood donation or major blood loss (greater than equal to [≥]500 mL) within the last 8 weeks, or plasma donation with the last 4 weeks preceding the first day of IMP dosing
- •Current non-smokers or light smoker with a history of long-term, heavy smoking (>10 pack-years)
- •Previously dosed in this trial
- •Mental incapacity or language barrier precluding adequate understanding or co-operation
- •Considered by the investigator to be unsuitable to participate in the trial for any other reason
研究组 & 干预措施
Follitropin delta 12 μg
Participants received single subcutaneous abdominal injection of Follitropin delta 12 μg on Day 1.
干预措施: Follitropin Delta (Drug)
Follitropin delta 18 μg
Participants received single subcutaneous abdominal injection of Follitropin delta 18 μg on Day 1.
干预措施: Follitropin Delta (Drug)
Follitropin delta 24 μg
Participants received single subcutaneous abdominal injection of Follitropin delta 24 μg on Day 1.
干预措施: Follitropin Delta (Drug)
结局指标
主要结局
Terminal Elimination Half-life (t½)
时间窗: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Apparent Total Systemic Clearance (CL/F)
时间窗: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Area Under the Serum Concentration-time Curve From Dosing up to Time t (AUCt)
时间窗: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
AUCt is defined as the area under the serum concentration-time curve from dosing up to time t, where t is the last time point at which the concentration is above the lower limit of quantification.
Apparent Volume of Distribution Associated With the Terminal Phase (VZ/F)
时间窗: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Area Under the Serum Concentration-time Curve From Dosing to Infinity (AUC)
时间窗: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Area under the concentration-time curve from dosing to infinity.
Maximum Serum Concentration Observed (Cmax)
时间窗: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Maximum concentration observed in serum.
Time of Maximum Observed Serum Concentration (Tmax)
时间窗: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Time of maximum observed concentration in serum.
次要结局
- Number of Participants With Clinically Significant Abnormal Changes in Electrocardiogram (ECG)(At screening, on Day -1, at 12, 24, 48 hours postdose, and at the follow-up visit (Day 11))
- Number of Participants With Adverse Events (AEs) and Type of AEs(From signed informed consent until the end-of-trial visit (Day 28))
- Number of Participants With Clinically Significant Abnormal Findings in Laboratory Parameters(At screening, on Day -1 and Day 3, and at the follow-up visit (Day 11))
- Number of Participants With Treatment-induced Anti-follicle-stimulating Hormone (Anti-FSH) Antibodies(On Day 1 predose, Day 7, and Day 28)
- Number of Participants With Clinically Significant Abnormal Changes in Vital Signs(At screening, on Day -1, at 12, 24, 48 hours postdose, and at the follow-up visit (Day 11))
- Frequency of Injection Site Reactions(Immediately, 30 minutes, and 24 hours after administration)