NCT02157558已完成1 期
A Phase 1, Open-label, Single-center, 2-period, Single Sequence Drug-drug Interaction Study to Evaluate the Effects of Multiple-dose Telotristat Etiprate on the Pharmacokinetics of Single-dose Fexofenadine, a Sensitive P Glycoprotein Substrate, in Healthy Male and Female Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Fexofenadine plasma concentration in combination with steady state telotristat etiprate
研究概览
简要总结
The purpose of this study is to evaluate the effects of steady-state telotristat ethyl on the pharmacokinetics (PK) of single-dose fexofenadine in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Healthy adult subjects aged ≥18 to ≤55 years of age at screening
- •Body mass index ≥18.0 to ≤32.0 kg/m^2
- •Acceptable vital signs at Screening: Systolic blood pressure = 90-140 mm Hg, Diastolic blood pressure = 50-90 mm Hg, Heart rate = 40-100 beats per minute
- •Willingness to adhere to the restrictions outlined in the protocol
- •Able to comprehend and sign the Informed Consent Form
排除标准
- •Presence of any clinically significant physical, laboratory, or ECG finding that may interfere with the study in the opinion of the Investigator
- •Use of any medications, herbal tea, energy drink, herbal products, or supplements within 14 days of Day 1
- •Receipt of any investigational agent or study drug within 30 days or 5 half-lives prior to Screening
- •Receipt of any protein- or antibody-based therapeutic agent within 3 months of Screening
- •Prior exposure to telotristat etiprate
- •Use of tobacco, smoking cessation products, or nicotine products within 3 months prior to Screening
- •History of major surgery within 6 months prior to Screening
- •History of any GI surgery that may induce malabsorption
- •History of any serious adverse reaction or hypersensitivity to any component of fexofenadine
- •History of renal disease, or significantly abnormal glomerular filtration rate (<90 mL/min as calculated using the Cockcroft-Gault equation) at Screening
- •History of hepatic disease, or significantly abnormal liver function tests at Screening
- •History of any clinically significant psychiatric, renal, hepatic, pancreatic, cardiovascular, neurological, endocrinologic, hematological, or GI abnormality
- •History of any active infection within 14 days prior to first dosing
- •History of alcohol or substance abuse within 2 years prior to Screening
- •Positive hepatitis panel (including hepatitis B surface antigen and hepatitis C virus antibody) or positive human immunodeficiency virus antibody screens
- •Concurrent conditions that could interfere with safety and/or tolerability measurements
- •Donation or loss of >500 mL of blood or blood product within 3 months prior to Screening
- •Women who are breastfeeding or are planning to become pregnant during the study
- •Positive serum pregnancy test (females only)
- •Positive urine screen for selected drugs of abuse and cotinine
- •Consumption of alcohol within 48 hours prior to study start
- •Consumption of caffeine- and/or xanthine-containing products within 72 hours of study start
- •Consumption of grapefruit, Seville oranges, and grapefruit- or Seville orange-containing products within 72 hours prior to study start
- •Unable or unwilling to communicate or cooperate with the Investigator for any reason
- •Use of any drugs or substances that are known to be substrates, inducers, or inhibitors of CYP3A4 within 30 days prior to the first dose
研究组 & 干预措施
All subjects
Experimental
All subjects will receive a single oral dose of fexofenadine on Day 1 while fasting. Days 2 to 5 will be Washout days. On Day 6, subjects will begin a 5 day telotristat etiprate regimen. On Day 10 subjects will be given the morning telotristat etiprate dose concomitantly with a single dose of fexofenadine while fasting.
干预措施: Fexofenadine (Drug)
All subjects
Experimental
All subjects will receive a single oral dose of fexofenadine on Day 1 while fasting. Days 2 to 5 will be Washout days. On Day 6, subjects will begin a 5 day telotristat etiprate regimen. On Day 10 subjects will be given the morning telotristat etiprate dose concomitantly with a single dose of fexofenadine while fasting.
干预措施: Telotristat etiprate (Drug)
结局指标
主要结局
Fexofenadine plasma concentration in combination with steady state telotristat etiprate
时间窗: Day 10
次要结局
- Number of treatment emergent adverse events(14 days)
研究者
研究点 (1)
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