NCT00419172已完成1 期
A Phase I, Single Center, Open-label, One-sequence Cross-over Study to Investigate the Effect of a Potent Inducer Rifampicin on the Pharmacokinetics of Deferasirox in Healthy Volunteers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 22
- 主要终点
- Evaluate the effect of rifampicin on pharmacokinetics after single dose administration of deferasirox
研究概览
简要总结
The study will consist of two open-label periods, a Treatment Period I (deferasirox) and a Treatment Period II (rifampicin+deferasirox). At least 18 subjects are expected to complete both treatment periods as per protocol. For all subjects, in addition to the two treatment periods, there will be a 21 day screening period, one baseline evaluation (the day preceding deferasirox administration in Treatment Period I), and an end-of-study evaluation (EOS). Study subjects will be required to remain in the unit from Day -1 until Day 17. EOS evaluation (final safety assessment) will be performed 7-10 days after the last dose of rifampicin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Able and willing to provide written informed consent prior to study participation
- •Male subjects from 18 - 45 years of age in good health and no evidence of iron deficiency. Subjects of reproductive potential must use barrier contraception throughout the trial.
- •Able to communicate well with the investigator and comply with the requirements of the study
- •Subjects must have a body mass index (BMI) between 18 and
- •Serum ferritin value ≥20 ng/mL and transferrin saturation (Iron/TIBC) ≥15% at screening
排除标准
- •History or presence of impaired renal function
- •Abnormal serum electrolytes (e.g. sodium, potassium, chloride, or bicarbonate), magnesium and calcium
- •Evidence of urinary obstruction or difficulty in voiding at screening
- •Anemia (defined as hemoglobin < 13 g/dL)
- •A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at screening
- •Subjects with a known history of HIV seropositivity or history of immunocompromise
- •A past medical history of any ECG abnormalities or a family history of a prolonged QT-interval syndrome
- •Donation or loss of 400 mL blood or more within 12 weeks prior to dosing
- •Smokers (use of tobacco products in the previous 3 months). * Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Evaluate the effect of rifampicin on pharmacokinetics after single dose administration of deferasirox
次要结局
- Assess the safety and tolerability of concomitant administration of rifampicin and deferasirox
研究者
相似试验
已完成
1 期
DDI Study With Multiple-dose LX4211 and Single Dose DigoxinHealthyNCT02300350Lexicon Pharmaceuticals24
已完成
1 期
Relative Bioavailability Of A Crizotinib Oral Liquid Formulation To Crizotinib Formulated CapsuleHealthyNCT01297595Pfizer22
已完成
1 期
DDI Study With Multiple-dose LX4211 and Single Dose RosuvastatinHealthyNCT02300363Lexicon Pharmaceuticals24
Unknown
1 期
Effect of Food on Pharmacokinetics of Salvianolic Acid A in Healthy SubjectsHealthyNCT03791463Peking University First Hospital14
已完成
1 期
A Randomized, Phase I, Cross-Over Study to Assess the Relative Bioavailability of Single-Dose Cobimetinib (GDC-0973) in Tablet vs. Capsule FormulationHealthy VolunteerNCT02136524Genentech, Inc.28