Phase I Trial Investigating the Pharmacokinetics And Safety Of LPI 001

JRCT ID: jRCT2051200154

Registered date:12/03/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: early medication abortion
• Date of first enrollment: 25/03/2021
• Target sample size: 24
• Study type: Interventional
• Intervention(s): Three doses of LPI 001 are orally administered for one subject; 50 mg (low dose) in Period 1, 100 mg (medium dose) in Period 2, and 200 mg (high dose) in Period 3. Each IMP should be administered orally as a single dose with 200 mL of water after at least a 10-hour fasting period. The dose escalation of the IMP in Periods 2 and 3 will be determined by the Investigator after their review of the safety of each subject in the preceding treatment period. The dosing interval between each period of the IMP should be at least 19 days.

Outcome(s)

• Primary Outcome: Phamacokinetics, Safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 65age old
• Gender: Female

Include criteria

(1) Japanese or Caucasian women aged 20 years or older and younger than 65 years at the time of informed consent
(2) A body mass index (BMI) of 18.5 or more and less than 30.0 at screening visit

Exclude criteria

(1) Subjects who are positive for the pregnancy test at the screening or on the day before administration of the IMP, or are breastfeeding
(2) Subjects with a history of surgical procedures on the myometrium, such as hysterectomy, or a current Medical history of dysmenorrhea or menorrhagia
(3) Subjects with a complication or a history of endometriosis, uterinefibroids, or hyperprolactinemia
(4) Subjects with a complication or a history of malignant neoplasm
(5) Subjects with a complication affecting blood coagulation or fibrinolytic system
(6) Subjects with a history of hypersensitivity to IMP
(7) Subjects who have received hormone therapy with estrogen or progesterone within the past 90 days

Related Information

• Primary Sponsor: Shiozawa Toshiaki