Mechanistic Investigation Of Intestinal Cytochrome p450 3A4 Following Roux-en-Y Surgery And Its Effect on Plasma Concentrations of Buspirone
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 12
- 主要终点
- Area-under-the-curve
研究概览
简要总结
This study is to compare intestinal Cytochrome P450 3A4 (CYP3A4) activity in 9-18 month post weight loss surgery Roux-en-Y Gastric Bypass (RYGB) versus control subjects who have not had a weight loss surgery and are of similar age, gender, body mass index as the gastric bypass group. For this purpose, we will compare post-bariatric surgery patients with control subjects on alterations in systemic exposure of buspirone, a CYP3A4 substrate, when administered with grapefruit juice, a selective intestinal CYP3A4 inhibitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female
- •Age 18-65 (inclusive, at time of informed consent)
- •No tobacco use in the past three months.
- •Underwent Roux-en-Y Gastric Bypass weight loss surgery 9-18 months prior to study OR has not had a weight loss surgery but matches the gastric bypass patients on age, gender, and BMI.
- •Ability to read, write and understand English.
- •Expresses the ability/willingness to consume grapefruit juice.
排除标准
- •Taking a medication that has a clinically significant interaction with buspirone or grapefruit juice or an interaction that may alter the study data.
- •Hypersensitivity to buspirone or any excipient contained within the dosage forms or grapefruit juice.
- •Inability to tolerate repeated blood draws.
- •Any history of bipolar disorder or a psychotic disorder.
- •Current major depressive disorder or current suicidality.
- •Alcohol or substance dependence in the past year.
- •Currently pregnant or lactating or unwillingness to use medically accepted contraception during study.
- •Taking a medication which significantly alters gastrointesinal transit time.
- •Medical conditon which may increase participant risk with buspirone or grapefruit juice.
- •Self reported history of viral hepatits or HIV.
- •Positive urine drug screen unless documented prescription of a non-interacting medication.
- •Renal impairment as evidenced by an estimated glomerular filtration rate (eGFR) of less than or equal to 60 ml/min/1.73 m2 or other abnormality on a renal panel that the medical provider feels puts the participant at risk.
- •Hepatic insufficiency as defined by any hepatic enzyme greater than 3x the upper limit of normal or other hepatic laboratory abnormalities at the discretion of the medical provider.
- •Any contraindication to bioelectrical impedance analysis (BIA) such as pregnancy, the presence of a pacemaker or other implanted mechanical device.
研究组 & 干预措施
Buspirone
Buspirone alone
干预措施: Buspirone (Drug)
Buspirone
Buspirone alone
干预措施: Buspirone and Grapefruit Juice (Drug)
Buspirone plus grapefruit juice
Buspirone plus grapefruit juice
干预措施: Buspirone (Drug)
Buspirone plus grapefruit juice
Buspirone plus grapefruit juice
干预措施: Buspirone and Grapefruit Juice (Drug)
结局指标
主要结局
Area-under-the-curve
时间窗: 9-18 months following RYGB
The primary aim of this study is to compare the relative difference between the area-under-the-curve (AUC) of buspirone alone (buspirone) with the AUC of buspirone in the presence of grapefruit juice (buspirone + GFJ) in patients who underwent RYGB 9-18 months prior versus a control group of participants who have not undergone bariatric surgery.
次要结局
- Composite of pharmacokinetic measures compared between buspirone and buspirone with grapefruit juice in participants who have undergone RYGB and nonsurgical control participants.(9-18 months following RYGB)
- Compare GLP-2 levels between the buspirone and buspirone with grapefruit juice in participants who have undergone RYGB and nonsurgical control participants.(9-18 months following RYGB)
研究者
Kristine Steffen
Associate Professor
North Dakota State University