Prospective, Open-Label, Randomized, Two-Period, Two-Sequence, Crossover Study Comparing RP-G28 Administered in the Fasted State and the Effect of a Standard Meal on the Pharmacokinetic Profile of RP-G28 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration-time curve from time 0 extrapolated to infinity
研究概览
简要总结
Randomized, open-label, 2-period, 2-sequence, crossover study to evaluate the effect of a standard meal on the pharmacokinetic (PK) profile of orally administered RP-G28.
详细描述
This randomized, open-label, 2-period, 2-sequence, crossover study is designed to evaluate the effect of a standard meal on the pharmacokinetic (PK) profile of orally administered RP-G28, which is being developed for the treatment of lactose intolerance. The study consists of a screening visit (during the interval from Day -21 to Day -3), baseline/check-in to the clinical research unit (Day -2 to Day -1), 2 treatment periods (Day 1 and Day 3), a 48-hour washout between doses, check-out from the clinical research unit (Day 4), and 1 follow-up phone call conducted 7 to 10 days after the final dose of the study drug (i.e., during the interval from Day 10 to Day 13). The duration of subject study participation is approximately 5 weeks. Plasma samples for PK analysis will be taken at specified timepoints from 24 hours prior to each dose through 24 hours after each dose.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects between 18 and 60 years of age
- •Subjects with body weights greater than or equal to 50 kg and a body mass index (BMI) between 18 kg/m2 and 32 kg/m2
- •Female subjects of childbearing potential and males and their female partner(s) of childbearing potential must agree to use 2 forms of contraception, 1 of which must be a barrier method, during the study and for 30 days after the end of the study
排除标准
- •Pregnant or lactating females or male partners of females who are pregnant or lactating.
- •Subjects with any history of clinically significant bronchopulmonary, cardiovascular, cerebrovascular, hematologic, renal, hepatic, neurological, psychiatric, metabolic, or endocrine (eg, diabetes or thyroid disease) disease/disorder.
- •Use of prescription or over-the-counter (OTC) drugs, including vitamins and herbal or dietary supplements within 2 weeks (4 weeks for enzyme inducers including St. John's Wort) or 5 half-lives (whichever is longer), prior to the baseline/check-in visit, unless in the opinion of the investigator, prior use of the medication will not interfere with the study procedures or compromise subject safety.
- •Subjects with sustained supine or semi-supine systolic blood pressure of < 90 or > 140 mm Hg and supine or semi-supine diastolic blood pressure of < 50 or > 90 mm Hg at the screening or baseline/check-in visits.
- •Subjects with a resting heart rate of < 45 or > 100 beats per minute at the screening or baseline/check in visits.
- •Subjects with any clinically relevant deviation from normal during the physical examination, including vital signs at the screening or baseline/check-in visits.
- •Subjects with a known history of hypercalcemia, hyperparathyroidism, or hypervitaminosis D.
- •Use of calcium or vitamin D supplements (prescription or OTC) within 2 weeks prior to the baseline/check-in visit.
- •Subjects with a history of allergic reactions or hypersensitivities to galacto-oligosaccharides or any significant drug-related or food-related allergy (such as anaphylaxis or hepatotoxicity).
- •Regular use of probiotics, antacids, histamine type 2 (H2)-receptor blockers, proton pump inhibitors, or any medications that may alter the normal gastric environment and/or motility, or use of such medications within 2 weeks prior to the baseline/check-in visit.
研究组 & 干预措施
RP-G28 administered in the fasted state
RP-G28, 15 g dissolved in water, administered in the fasted state
干预措施: RP-G28 (Drug)
RP-G28 administered in the fed state
RP-G28, 15 g dissolved in water, administered immediately following the consumption of a standard non-dairy meal
干预措施: RP-G28 (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve from time 0 extrapolated to infinity
时间窗: Days 2 and 1 pretreatment; Day 1 post-treatment, Day 1-3 washout, Day 3 and 4 post-treatment
Assess systemic exposure of RP-G28 when administered in the fed and fasted state
次要结局
- Adverse events(2, 3, 2 and 1 days pretreatment; 1 - 13 days post-treatment)
- Serum chemistry(21 and 3 days pretreatment; day 4 post-treatment)
- Hematology(21 and 3 days pretreatment; day 4 post-treatment)
- Urinalysis(2, 3, 2 and 1 days pretreatment; day 1 and 3 post-treatment)