NCT02195635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 Octreotide Acetate Injection (Sandostatin®) on the Pharmacokinetics of Single-dose Telotristat Etiprate in Healthy Male and Female Subjects
适应症
干预措施
相关药物
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
- Plasma concentrations of metabolite LP-778902
研究概览
简要总结
To evaluate the effect of octreotide acetate injections (200 µg 3 times daily [tid]) on the pharmacokinetics (PK) of telotristat ethyl and its metabolite LP-778902 relative to administration of single-dose telotristat etiprate in healthy male and female subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 males or females ≥18 to ≤55 years of age
- •Body mass index 18.0 to 32.0 kg/m2, inclusive, at Screening
- •Vital signs (after at least 5 minutes resting in a supine position) at Screening that are within the following ranges: Systolic blood pressure, 90 to 140 mm Hg; Diastolic blood pressure, 50 to 90 mm Hg; Heart rate 40 to 100 beats per minute (bpm)
- •Willing to adhere to the prohibitions and restrictions specified in this protocol
- •Able to comprehend and willing to sign an Informed Consent Form
排除标准
- •Presence of clinically significant physical, laboratory, or electrocardiogram (ECG) findings at Screening or Check-in (Day 1) that, in the opinion of the Investigator and/or the Sponsor or Sponsor's representative, may interfere with any aspect of study conduct or interpretation of results
- •Use of any medications (prescription or over-the-counter), herbal tea, energy drinks, herbal products (eg, St. John's Wort, garlic, milk thistle, etc.), or supplements/supratherapeutic doses of vitamins within 14 days prior to the first dose administration and throughout the duration of the study, with the exception of those approved by the Investigator and/or the Sponsor or Sponsor's representative
- •Prior exposure to telotristat etiprate
- •Use of tobacco, smoking cessation products, or products containing nicotine within 3 months prior to Screening and for the duration of the study
- •History of any major surgery within 6 months prior to Screening
- •History of renal disease
- •History of hepatic disease, or significantly abnormal liver function tests (>1.5 x upper limit of normal [ULN])
- •History of gall bladder abnormalities
- •History of any endocrine disorder
- •History of alcohol or substance abuse within 2 years prior to Screening
- •Positive urine screen for drugs of abuse and cotinine
- •Consumption of caffeine- and/or xanthine containing products (eg, cola, coffee, tea, chocolate) within 72 hours prior to Check-in
- •Consumption of alcohol within 48 hours prior to Check in
- •Consumption of grapefruit, Seville oranges, and grapefruit- or Seville orange containing products within 72 hours prior to Check in
研究组 & 干预措施
Period 1
Experimental
Single oral dose of 500 mg telotristat etiprate on Day 1
干预措施: Telotristat etiprate (Drug)
Period 2
Other
Subcutaneous injections of 200 µg octreotide acetate three times daily with a single oral dose of 500 mg telotristat etiprate on Day 6
干预措施: Telotristat etiprate (Drug)
Period 2
Other
Subcutaneous injections of 200 µg octreotide acetate three times daily with a single oral dose of 500 mg telotristat etiprate on Day 6
干预措施: Octreotide acetate (Drug)
结局指标
主要结局
Plasma concentrations of metabolite LP-778902
时间窗: Days 1, 2, 3, 6, 7, 8
Plasma concentrations of telotristat ethyl
时间窗: Days 1, 2, 3, 6, 7, 8
次要结局
- Number of treatment-emergent adverse events(Up to 39 days)
研究者
研究点 (1)
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