JPRN-jRCT2071210049已完成1 期
A randomized, placebo-controlled, single-blind, dose escalation study to investigate the safety, tolerability and pharmacokinetics after single and multiple dose of elinzanetant in Japanese healthy female adult participants. - Single/multiple dose escalation study of elinzanetant in Japanese healthy female adult participants
Myoishi Masashi0 个研究点目标入组 62 人开始时间: 2021年7月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
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
- >= 40age old 至 <= 65age old（—）
- 性别
- Female
入选标准
- •Japanese participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, blood pressure, pulse rate, 12 lead electrocardiogram (ECG), body temperature, and laboratory tests.
- •- Non-smoker, at least from 3 months before the screening visit onwards.
- •- Body weight of at least 40 kg and body mass index (BMI)
- •within the range 18.0 and 30.0 kg/m^2 (inclusive).
排除标准
- •- Pregnant or breastfeeding women.
- •- Any clinically relevant abnormal findings in medical history and physical examination.
- •- History or evidence of any clinically relevant cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other clinically relevant disease.
- •- Relevant diseases or febrile illness within the last 4 weeks prior to the first study intervention administration.
- •- Regular use of medicines, or dietary supplements or other substances, e.g., carnitine products, anabolics, high dose vitamins.
- •- Use of any systemic or topical medicine or substance within 4 weeks before first study drug intervention, which oppose the study objectives, or which might influence them. This includes medicines and natural remedies (e.g St. Johns wort) that are altering the activity of CYP3A4 enzyme and the transporters Breast Cancer Resistance Protein (BCRP) and P-gp.
- •- ECG PR interval 210 msec, QT interval corrected using Bazetts formula (QTCB) 450 msec, QRS duration 110 msec at screening visit.
- •- ECG: PR interval > 210 msec, QT interval corrected using Bazetts formula (QTcB) >450 msec, QRS duration > 110 msec at screening visit.
- •- Systolic blood pressure below 90 or above 140 mmHg;
- •diastolic blood pressure below 40 or above 90 mmHg at
- •screening visit.
- •- Pulse rate below 50 or above 90 beats per minute (bpm; a lower pulse rate between 45 and 50 bpm is acceptable in case of normal thyroid function and absence of symptoms of bradycardia) at screening visit.
- •- Participants with a presence of any of the following, confirmed by a repeat test: aspartate aminotransferase (AST), alanine aminotransferase (ALT) and/or bilirubin above 1.2 x upper limit of normal (ULN) at screening visit.
- •- Participants with a presence of gamma-glutamyl transferase (GGT) > ULN confirmed by a repeat test, CK (creatine kinase) >2x ULN, and thyroid-stimulating hormone (TSH) outside normal range at screening visit.
- •- History of COVID-19 (coronavirus disease 2019).
- •- Suspected or confirmed active or prior SARS-CoV-2 (severe acute respiratory syndrome coronavirus type 2) infection according to local guidelines/practice.
- •- Contact with SARS-CoV-2- positive or COVID-19 patient within the last 4 weeks prior to admission to the study site.
- •- Positive SARS-CoV-2 viral RNA (ribonucleic acid) test.
- •- Vaccination against SARS-CoV-2 within 14 days before first administration of the study intervention or vaccination planned before completion of the last study visit.
研究者
相似试验
已完成
1 期
Phase 1 study of BAY 2395840 in Japanese healthy male participantsDiabetic neuropathic painJPRN-jRCT2071220060Myoishi Masafumi36
已完成
不适用
A Randomized, Blinded, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB033 in Healthy Adult Volunteersdemyelination10012303MSNL-OMON32724Biogen64
进行中（未招募）
1 期
Avexxin (AVX001) 3% Ointment (NG) in Atopic Dermatitis – safety and efficacy studyEUCTR2016-003013-96-DKAvexxin AS
进行中（未招募）
不适用
A randomized, placebo-controlled, double-blind, dose escalation study to evaluate the efficacy, safety and tolerability of the study drug BT971 in patients with rheumatoid arthritis receiving concomitant Methotrexate - n.a.Active rheumatoid arthritis, functional class II-IIIMedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritisEUCTR2008-001241-26-HUBiotest AG110
进行中（未招募）
不适用
A randomized, placebo-controlled, double-blind, dose escalation study to evaluate the efficacy, safety and tolerability of the study drug BT971 in patients with rheumatoid arthritis receiving concomitant MethotrexateEUCTR2008-001241-26-BGBiotest AG110