JPRN-jRCT2071230042进行中（未招募）1 期
Phase I/II clinical study to determine the pharmacokinetics, pharmacodynamics, and safety of multiple doses of AKP-022 or Relugolix in healthy Japanese premenopausal female subjects
Hozumi Hiroyasu0 个研究点目标入组 48 人开始时间: 2023年7月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 45age old（—）
- 性别
- Female
入选标准
- •Individuals who are capable of understanding the nature of the study and can provide written voluntary consent to participate in the study.
- •- Japanese premenopausal females who are aged 18 years or older and 45 years or younger at the time of informed consent.
- •- Individuals who had a normal menstrual cycle (>= 25 days and <= 38 days) and at least 2 menstrual cycles (>= 3 and <= 7 consecutive days of bleeding) during the 3 months before enrollment.
- •- Individuals who weigh at least 40 kg with body mass index (BMI) >= 17.6 kg/m2 and < 25.0 kg/m2 at screening.
- •- Individuals who are in good health when evaluated medically by the investigator or subinvestigator based on the medical history, medical examination, laboratory tests, electrocardiography, etc.
- •- Individuals who agree to use an appropriate barrier method of contraception at each sexual intercourse from the screening period to the end of the follow-up period or who are not of childbearing potential due to bilateral tubal ligation or hysteroscopic sterilization.
排除标准
- •- Individuals who are pregnant or lactating, wish to become pregnant between informed consent and the follow-up period, or intend to donate eggs during this period; Individuals with a positive pregnancy test at screening or on the day before the start of treatment.
- •- Individuals with undiagnosed uterine bleeding.
- •- Individuals with gynecological abnormality at screening that would interfere with participation in the study; Individuals with positive cervical cytology (other than negative for intraepithelial lesion or malignancy [NILM] according to the Bethesda System).
- •- Individuals with current or previous osteoporosis, osteopenia, or other metabolic bone disease.
- •- Individuals with current or previous disease considered inappropriate for participation in the study, such as gynecological diseases, psychiatric/neurological diseases, cerebrovascular/cardiovascular diseases, thrombosis, blood diseases, pulmonary diseases, or endocrine diseases.
- •- Individuals with current or previous cholelithiasis or cholecystitis.
- •- Individuals with current or previous malignancy within 5 years before informed consent.
- •- Individuals with AST, ALT, and/or total bilirubin > 1.5 times the upper limit of normal at screening.
- •- Individuals with current or previous dyslipidemia or any of the following test results at screening:
- •a. Fasting LDL cholesterol >= 140 mg/dL
- •b. Fasting triglycerides >= 150 mg/dL
- •- Individuals with current or previous diabetes mellitus or the following test result at screening:
- •a. Fasting plasma glucose >= 126 mg/dL
- •- Individuals with clinically significant ECG abnormality at screening.
- •- Individuals whose systolic blood pressure is outside the range of 90 to 140 mmHg, diastolic blood pressure is above 90 mmHg, or heart rate is outside the range of 45 to 100 bpm at screening.
- •- Individuals with impaired gastrointestinal, hepatic, or renal function that may affect the absorption, metabolism, or excretion of study drugs, or with previous cholecystectomy.
- •- Individuals who have smoked or used nicotine-containing products within 1 month before screening.
- •- Individuals with current or previous alcoholism.
- •- Individuals who test positive for drug abuse at screening.
- •- Individuals with a positive immunological test result at screening.
- •- Individuals who have used any of the following medications before screening:
- •a. Within 3 months: Oral contraceptives, sex hormone drugs, or danazol
- •b. Within 6 months: Injectable hormonal contraceptives, GnRH analogs, aromatase inhibitors, intrauterine device (IUD), or intrauterine system (IUS) (even if these devices have been removed within 6 months before screening)
- •- Individuals who are considered by the investigator or subinvestigator to be unsuitable for study treatment based on the medication status (including vitamins, herbs, and supplements) within 2 weeks before the start of study treatment.
- •- Individuals who have consumed Seville orange or grapefruit (including juice) within 7 days before the start of study treatment.
- •- Individuals with current or previous hypersensitivity to drug treatments in this study or any of their components or with current or previous severe hypersensitivity to any other drug (including heparin).
- •- Individuals in whom treatment with E2 or NETA is contraindicated.
- •a. Individuals with undiagnosed unexpected vaginal bleeding
- •b. Individuals with current, suspected, or previous breast cancer
- •c. Individuals with current, suspected, or previous estrogen-dependent malignancy (e.g., e
研究者
相似试验
已完成
1 期
Phase I /II and Pharmacological Clinical Study of Combination Chemotherapy with Irinotecan(CPT-11) and Erlotinib(Tarceva) for Recurrent Lung Cancerrecurrent non small cell lung cancer after chemotherapyJPRN-UMIN000004639Shimane university hospital45
已完成
1 期
Phase I/II study of LF111 (drospirenone) in healthy Japanese womeContraceptionJPRN-jRCT2071200065Kikuyama Ryoko12
招募中
1 期
AKP-009 Phase I clinical trialBenign prostatic hyperplasiaJPRN-jRCT2071230052Shimomiya Kazuhiro81
已完成
Unknown
Studying the safety and the pharmacokinetics after single dosing of KDF2001 in healthy adultEndocrine, nutritional and metabolic diseasesKCT0009163Kyung Dong Pharmaceutical40
已完成
1 期
Phase I/II clinical trial to evaluate the efficacy and safety of DFP-17729 in patients with unresectable/recurrent/progressive pancreatic cancerJPRN-UMIN000042064Delta-Fly Pharma, Inc.39