JPRN-jRCT2071210079已完成1 期
A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Multiple Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of INCB054707 When Administered Orally to Healthy Japanese Participants
eda Eiji0 个研究点目标入组 30 人开始时间: 2021年10月18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
- 30
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
- >= 20age old 至 <= 55age old（—）
- 性别
- Male
入选标准
- •Male healthy Japanese adult participants aged 20 to 55 years with a minimum weight of 48 kg.
- •- Body mass index between 18.0 and 30.5 kg/m2.
- •- No clinically significant findings in screening evaluations.
- •- Ability to swallow and retain oral medication.
- •- Willingness to avoid fathering children.
排除标准
- •- History of clinically significant cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease.
- •- History of rheumatologic/autoimmune disorders, except for minor eczema and rosacea.
- •- Resting pulse < 40 bpm or > 100 bpm, confirmed by repeat testing at screening.
- •- History or presence of an abnormal ECG before initial dose administration that, in the investigator's opinion, is clinically significant.
- •- Presence of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn's disease or chronic pancreatitis).
- •- Hemoglobin, WBC, platelet, or ANC that is out of the laboratory's range unless considered clinically insignificant by the investigator at screening or check-in.
- •- History of malignancy within 5 years of screening, with the exception of cured basal cell or squamous cell carcinoma of the skin.
- •- Current or recent (within 6 months of screening) clinically significant gastrointestinal disease or surgery (including cholecystectomy, excluding appendectomy) that could affect the absorption of study drug.
- •- Any major surgery within 6 months of screening.
- •- Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of screening (within 2 weeks for plasma donation).
- •- Blood transfusion within 4 weeks of check-in.
- •- Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.
- •- Positive test for HIV and known active HBV or HCV infection or risk of reactivation of HBV or HCV.
- •- History of alcoholism within 3 months of screening.
- •- Positive breath or urine test for ethanol or positive urine screen for drugs of abuse that are not otherwise explained by permitted concomitant medications or diet.
- •- Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug with another investigational medication or current enrollment in another investigational drug study.
- •- Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug with an inducer or inhibitor of CYP3A4, P-gp, or BCRP.
- •- Current use of prohibited medication.
- •- Consumption of Seville oranges, grapefruit or grapefruit juice, pomelos, exotic citrus fruits, grapefruit hybrids, or fruit juices within 72 hours before the first dose of study drug.
- •- History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator.
- •- Known hypersensitivity or severe reaction to INCB054707 or any excipients of INCB054707.
- •- Inability to undergo venipuncture or tolerate venous access.
- •- Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations, in the opinion of the investigator.
- •- History of tobacco- or nicotine-containing product use within 1 month of screening.
- •- Use of prescription drugs within 14 days of study drug administration or nonprescription medications/products within 7 days of study drug administration.
- •- Any condition that would, in the investigator's judgment, interfere with full participation in the study.
- •- Positive syphilis test.
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