A Phase 1, Randomized, Single Center, Open Label, 2 Sequence, 2 Period, Crossover Study to Evaluate the Effect of Food on the Single Dose Pharmacokinetics of Telotristat Etiprate (LX1606 Hippurate) in Healthy Male and Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Plasma concentrations of telotristat ethyl
研究概览
简要总结
This study is designed to evaluate the effect of food on the pharmacokinetics (PK) of telotristat ethyl and its metabolite LP-778902 relative to administration of single dose telotristat etiprate in the fasted state in healthy adult male and female subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Able and willing to ingest an entire high fat/high caloric breakfast meal within 30 minutes
- •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 study start
- •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 prior to 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 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 Screening
- •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
研究组 & 干预措施
Treatment A
Subjects will receive a single 500 mg (as free base) dose of telotristat etiprate (as 2 × 250 mg tablets) on Day 1 in a fed condition. Days 2 to 5 will be Washout Days. On Day 6, subjects will receive a single 500 mg (as free base) dose of telotristat etiprate (as 2 × 250 mg tablets) 1 in a fasted condition.
干预措施: Telotristat etiprate (Drug)
Treatment B
Subjects will receive a single 500 mg (as free base) dose of telotristat etiprate (as 2 × 250 mg tablets) on Day 1 in a fasted condition. Days 2 to 5 will be Washout Days. On Day 6, subjects will receive a single 500 mg (as free base) dose of telotristat etiprate (as 2 × 250 mg tablets) 1 in a fed condition.
干预措施: Telotristat etiprate (Drug)
结局指标
主要结局
Plasma concentrations of telotristat ethyl
时间窗: Days 1, 2, 3, 6, 7, 8
Plasma concentration of metabolite LP-778902
时间窗: Days 1, 2, 3, 6, 7, 8
次要结局
- Number of treatment emergent adverse events(10 days)