A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Metabolism of [14C] CR845 in Patients With End Stage Renal Disease on Hemodialysis and in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Measure of the [14C] CR845 and total radioactivity (total [14C] CR845-equivalents) in plasma, urine, feces, and dialysate will be determined.
研究概览
简要总结
The objectives of this study are to evaluate the in vivo metabolite profiling and characterization of CR845 administered intravenously (IV) in patients on hemodialysis (HD) and in healthy subjects; and to determine the pharmacokinetics of radiolabeled [14C] CR845 administered as a single IV bolus in patients on HD and in healthy subjects.
详细描述
This is a Phase 1, open-label, single-radiolabeled dose, non-randomized study in 6 male patients on HD and 6 healthy male subjects. The study will consist of a Screening Period, a Study Period, and an End-of-Study assessment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Has a concomitant disease or any medical condition that, in the opinion of the Investigator, could pose undue risk to the patient, impede completion of the study procedures, or would compromise the validity of the study measurements, including, but not limited to:
- •Known or suspected history of alcohol, narcotic, or other drug abuse, or substance dependence within 12 months prior to Screening;
- •Significant systolic or diastolic heart failure (eg, New York Heart Association Class IV congestive heart failure [Appendix 1]);
- •Severe mental illness or cognitive impairment (eg, dementia);
- •Any other relevant acute or chronic medical or neuropsychiatric condition.
- •History of important drug or other allergy (except for untreated, asymptomatic seasonal allergies at time of dosing) unless deemed not clinically significant by the Investigator;
- •Use of any beverages and foods containing alcohol, quinine (tonic water), grapefruit, broccoli, Brussels sprouts, Seville oranges, pomegranate, star fruit, char-grilled meat, or caffeine/xanthine from 48 hours prior to dosing with study medication without evaluation and approval by the Investigator;
- •Use of any over-the-counter (OTC) medication (including nutritional or dietary supplements, herbal preparations, or vitamins, chapparal, comfrey, germander, gin bu huan, kava, pennyroyal, skullcap, St. John's Wort, or valerian) within 7 days prior to dosing with study medication;
- •Use of any new prescription medication from 14 days prior to dosing with study medication without evaluation and approval by the Investigator;
- •Has been treated with any known drugs that are moderate or strong inhibitors/inducers of cytochrome P450 (CYP) enzymes (e.g., barbiturates, phenothiazines, cimetidine, carbamazepine) within 30 days prior to dosing with study medication, and that, in the Investigator's judgment, may impact subject safety or the validity of the study results;
- •Positive results for human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg);
- •Is a healthy subject with positive results for hepatitis C virus (HCV) antibody at Screening. Note: Subjects with HD who test positive for HCV antibody may be allowed to enroll at the discretion of the Principal Investigator if their liver function tests are not otherwise clinically significant;
- •Has donated blood or has had an acute loss of blood (˃500 mL) during the 3 months prior to study drug administration;
- •Previous administration of any [14C] labeled drug substance within 1 year of study drug administration;
- •Has irregular bowel habits. "Irregular" being defined for the purpose of this study as NOT having a bowel movement at least every 2 days.)
- •Has been involved in an occupation that requires monitoring for radiation exposure (eg, X-ray technician);
研究组 & 干预措施
[14C] CR845
Subjects will receive a single dose of [14C] CR845 IV solution administered as an IV bolus on Day 1.
干预措施: [14C] CR845 (Drug)
结局指标
主要结局
Measure of the [14C] CR845 and total radioactivity (total [14C] CR845-equivalents) in plasma, urine, feces, and dialysate will be determined.
时间窗: Day 1 to up to 7 days post dose in healthy volunteers and Day 1 to up to 14 days post dose in patients on HD
Quantitation of possible CR845 metabolites will be assessed.
时间窗: Day 1 to up to 7 days post dose in healthy volunteers and Day 1 to up to 14 days post dose in patients on HD
Extent of recovery of [14C] CR845 and radioactivity related to [14C] CR845 in plasma, urine, feces, and dialysate, as applicable, will be derived.
时间窗: Day 1 to up to 7 days post dose in healthy volunteers and Day 1 to up to 14 days post dose in patients on HD
Presence of possible CR845 metabolites will be assessed.
时间窗: Day 1 to up to 7 days post dose in healthy volunteers and Day 1 to up to 14 days post dose in patients on HD
Cumulative amount of [14C] CR845 and [14C] CR845-equivalents in urine and feces over the collection period will be calculated.
时间窗: Day 1 to up to 7 days post dose in healthy volunteers and Day 1 to up to 14 days post dose in patients on HD
次要结局
- Frequency and severity of adverse events by treatment group(Day 1 to up to 7 days post dose in healthy volunteers and Day 1 to up to 14 days post dose in patients on HD)