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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pharmacokinetics Parameter : Cmax of INCB054707
研究概览
简要总结
This is a single-center, randomized, double-blind, placebo-controlled, sponsor-unblinded, Phase 1 study designed to evaluate the safety, tolerability, and PK of escalating oral doses of INCB054707 in healthy male Japanese participants. Participants in each cohort will be divided into placebo or INCB054707 by a 3:1 INCB054707:placebo random assignment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
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/m
- •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.
研究组 & 干预措施
INCB054707 (Dose A)
Participants will be administered single-dose INCB054707 on Day 1 followed by once daily dose of INCB054707 on Days 5 to 12 (8 doses) administered orally after a fast of ≥ 8 hours
干预措施: INCB054707 (Drug)
INCB054707 (Dose B)
Participants will be administered a single-dose INCB054707 on Day 1 followed by once daily dose of INCB54707 on Days 5 to 12 (8 doses) administered orally after a fast of ≥ 8 hours.
干预措施: INCB054707 (Drug)
Placebo (Dose A)
Participants will be administered single-dose placebo on Day 1 followed by once daily dose of placebo on Days 5 to 12 (8 doses) administered orally after a fast of ≥ 8 hours
干预措施: Placebo (Drug)
Placebo (Dose B)
Participants will be administered single-dose placebo on Day 1 followed by once daily dose of placebo on Days 5 to 12 (8 doses) administered orally after a fast of ≥ 8 hours
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacokinetics Parameter : Cmax of INCB054707
时间窗: 17 Days
Maximum Observed Plasma Concentration of INCB054707
Pharmacokinetics Parameter : tmax of INCB054707
时间窗: 17 Days
Time to reach maximum plasma concentration of INCB054707
Pharmacokinetics Parameter : AUC(0-∞) of INCB054707
时间窗: 17 Days
Area Under the Concentration-time Curve From 0 to Infinity of INCB054707
Number of participants with Treatment Emergent Adverse Events (TEAE'S)
时间窗: 3 months
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Pharmacokinetics Parameter : Cmin of INCB054707
时间窗: 17 Days
Minimum Observed Plasma Concentration of INCB054707
Pharmacokinetics Parameter : AUC(0-tau) of INCB054707
时间窗: 17 Days
Area under the single-dose or steady-state plasma concentration-time curve from hour 0 to the end of the dosing period of INCB054707
Pharmacokinetics Parameter : AUC(0-t) of INCB054707
时间窗: 17 Days
Area Under the concentration- time curve up to the last measurable concentration of INCB054707
次要结局
- Pharmacokinetics Parameter : t1/2 of INCB054707(17 Days)
- Pharmacokinetics Parameter : CL/F of INCB054707(17 Days)
- Pharmacokinetics Parameter : Vz/F of INCB054707(17 Days)
- Pharmacokinetics Parameter : Cavg of INCB054707(17 Days)
- Pharmacokinetics Parameter : λz of INCB054707(17 Days)