"Pharmacokinetic Study of Nicotinamide Riboside"
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Percent change in the average steady state concentration (Css) of nicotinamide riboside (NR) on day 9 (following up titration of nicotinamide riboside to 1000 mg by mouth twice daily) compared to pre-dose baseline.
研究概览
简要总结
Nicotinamide riboside (NR) has been available over the counter as a nutraceutical (Niagen®, ChromaDex, Inc.) since the summer of 2013. However, classical pharmacokinetic (PK) data for NR have not been reported in humans. This study will use a recently-developed, whole blood assay for NR to assess the pharmacokinetics of NR at a maximum dose of 1000 mg twice daily, and will collect history, physical examination and laboratory data to determine the safety and tolerability of NR in eight, healthy volunteers. In addition, whole blood nicotinamide adenine dinucleotide (NAD) levels will be measured at each time point, to determine whether this NR dose significantly raises whole blood NAD levels.
详细描述
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On Day 1, participants will have a baseline assessment, including blood pressure and heart rate, as well as baseline assessment of "safety" labs: complete blood count with white blood count differential and platelets, serum chemistry panel (sodium, potassium, chloride, glucose, blood urea nitrogen and creatinine), uric acid, creatine kinase, aspartate aminotransferase and alanine aminotransferase, and lactate dehydrogenase.
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Participants will receive 250 mg nicotinamide riboside (NR) by mouth daily on Days 1-2, 250 mg NR by mouth twice daily on Days 3-4, 500 mg NR twice daily by mouth on Days 5-6 and 1000 mg NR twice daily by mouth on Days 7-8.
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On Day 2, a blood sample will be obtained from each participant to measure serum chemistry panel to assess for the possibility of hyperkalemia and hyperglycemia. In addition, an instant read potassium will be measured using a point-of-care device available on the University of Washington (UW) General Clinical Research Center (GCRC). If the potassium is greater than 5.5, a repeat value and an ECG will be performed and the Study Investigator. If it is greater than 6.0, the Study Investigator will evaluate the subject for admission.
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On Day 9 prior to receiving their morning dose, participants will be admitted to the UW GCRC for an overnight stay.
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In the UW GCRC, the participants will receive the last 1000 mg dose of NR at time=0.
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Blood samples will be collected at time = 30 minutes and at 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours.
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Whole blood samples will be frozen at -80 degrees C until assayed for NR and NAD+.
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"Safety labs" performed on Day 1 will be repeated
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, adult (age 21-50 years), male or female
- •Willing and able to provide informed consent
排除标准
- •Current smoking
- •Receiving concurrent medications or supplements
- •History of liver, renal, cardiovascular, endocrine, or neurological disease
- •Known allergy to niacin or nicotinamide ribosome
- •Unwilling to refrain from drinking alcohol during the duration of the study
结局指标
主要结局
Percent change in the average steady state concentration (Css) of nicotinamide riboside (NR) on day 9 (following up titration of nicotinamide riboside to 1000 mg by mouth twice daily) compared to pre-dose baseline.
时间窗: 9 days
Percent change in the average steady state concentration (Css) of nicotinamide riboside (NR) on day 9 (following up titration of nicotinamide riboside to 1000 mg by mouth twice daily) compared to pre-dose baseline. Group mean values will be compared by paired t-test, with correction for multiple primary endpoints.
Percent change in the average steady state concentration (Css) of nicotinamide adenine dinucleotide (NAD) on day 9 (following up titration of nicotinamide riboside to 1000 mg by mouth twice daily) compared to pre-dose baseline.
时间窗: 9 days
Percent change in the average steady state concentration (Css) of nicotinamide adenine dinucleotide (NAD) on day 9 (following up titration of nicotinamide riboside to 1000 mg by mouth twice daily) compared to pre-dose baseline. Group mean values will be compared by paired t-test, with correction for multiple primary endpoints.
次要结局
- Effect of nicotinamide riboside on serum potassium levels(9 days)
- Effect of nicotinamide riboside on serum creatine kinase levels(9 days)
- Effect of nicotinamide riboside on serum uric acid levels(9 days)
- Effect of nicotinamide riboside on serum glucose levels(9 days)
- Effect of nicotinamide riboside on serum alanine aminotransferase levels(9 days)
研究者
Kevin O'Brien
Professor of Medicine
University of Washington