An Open-Label Study to Assess the Effect of Itraconazole, Rifampin, and Acid-Reducing Agents on INCB161734 Pharmacokinetics When Administered Orally in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Pharmacokinetics Parameter (PK): Cmax of INCB161734
研究概览
简要总结
This study is conducted to assess the effect of itraconazole, rifampin, and acid-reducing agents on INCB161734 pharmacokinetics when administered orally in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to comprehend and willingness to sign a written ICF for the study.
- •Age 18 to 55 years, inclusive, at the time of signing the ICF.
- •Body mass index between 18.0 and 32.0 kg/m2 (inclusive).
- •Willingness to adhere to study-related prohibitions, restrictions, and procedures.
- •Ability to swallow and retain PO medication.
- •Willingness to avoid pregnancy or fathering children based on the criteria defined in the prootcol.
排除标准
- •History of uncontrolled or unstable cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening.
- •History of rheumatologic/autoimmune disorders and immune deficiency/immunologic defects.
- •History of major bleeding or thrombosis, including myocardial infarction/stroke and pulmonary embolism/deep vein thrombosis.
- •Known tuberculosis infection that is active or participant-reported history of tuberculosis or treatment thereof.
- •Resting pulse < 40 bpm or > 100 bpm, confirmed by repeat testing at screening.
- •Presence of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn disease or chronic pancreatitis).
- •Any major surgery within 12 weeks of screening.
- •Positive test for hepatitis B virus, hepatitis C virus, or HIV. Note: Participants whose results are compatible with prior immunization or immunity due to infection for hepatitis B may be included at the discretion of the investigator.
- •Positive urine or breath test for ethanol or positive urine or serum screen for drugs of abuse that are not otherwise explained by permitted concomitant medications or diet.
- •Use of tobacco- or nicotine-containing products within 1 month of screening.
- •Women who are pregnant or breastfeeding.
- •eGFR < 90 mL/min/1.73 m2 based on the CKD-EPI equation.
- •Any history of hypersensitivity or intolerance to itraconazole, rifampin, esomeprazole or any other PPI, or famotidine or any other H2 antagonist.
- •Other protocol-defined Inclusion/Exclusion Criteria may apply.
研究组 & 干预措施
Cohort 1
INCB161734 and itraconazole will be administered at protocol defined doses.
干预措施: INCB161734 (Drug)
Cohort 1
INCB161734 and itraconazole will be administered at protocol defined doses.
干预措施: Itraconazole (Drug)
Cohort 2
INCB161734 and rifampin will be administered at protocol defined doses.
干预措施: INCB161734 (Drug)
Cohort 2
INCB161734 and rifampin will be administered at protocol defined doses.
干预措施: Rifampin (Drug)
Cohort 3
INCB161734 and esomeprazole will be administered at protocol defined doses.
干预措施: INCB161734 (Drug)
Cohort 3
INCB161734 and esomeprazole will be administered at protocol defined doses.
干预措施: Esomeprazole (Drug)
Cohort 4
INCB161734 and famotidine will be administered at protocol defined doses.
干预措施: INCB161734 (Drug)
Cohort 4
INCB161734 and famotidine will be administered at protocol defined doses.
干预措施: Famotidine (Drug)
结局指标
主要结局
Pharmacokinetics Parameter (PK): Cmax of INCB161734
时间窗: Up to 2 months
Defined as maximum observed plasma or serum concentration of INCB161734.
Pharmacokinetics Parameter: AUC(0-t) of INCB161734
时间窗: Up to 2 months
Defined as the area under the concentration-time curve up to the last measurable concentration of INCB161734.
Pharmacokinetics Parameter: AUC 0-∞ of INCB161734
时间窗: Up to 2 months
Defined as the area under the concentration-time curve from 0 to infinity of INCB161734.
次要结局
- Number of participants with Treatment-emergent Adverse Events (TEAEs)(Up to 2 months)
- Pharmacokinetics Parameter: Tmax of INCB161734(Up to 2 months)
- Pharmacokinetics Parameter: t1/2 of INCB161734(Up to 2 months)
- Pharmacokinetics Parameter: CL/V of INCB161734(Up to 2 months)
- Pharmacokinetics Parameter: Vz/F of INCB161734(Up to 2 months)
- Pharmacokinetics Parameter: AUC%extrap of INCB161734(Up to 2 months)