2024-512673-28-00招募中4 期
Double-blind placebo-controlled cross-over MRI study to evaluate the effect of naloxegol and codeine on gastrointestinal motility and volumes
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- UZ Leuven
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- investigation of the effect of the 3 drug-arms (placebo+placebo, naloxegol+codeine, placebo+codeine) on both colonic motility and segmental colorectal volumes at baseline, after an oat porridge meal and after bisacodyl administration
研究概览
简要总结
To further understand the mechanism of action of naloxegol in healthy volunteers
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained
- •Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.
- •HV is a man or woman aged 18 to 65 years, inclusive, at screening.
- •Normal stool pattern of between 3 defecations per day and 3 per week with a Bristol Stool Form Scale (BSFS) of 1, 2, 6 or 7 in less than 25% of defaecations.
- •HV has not used any opioid medication 14 days prior to randomization.
- •Medications taken for the treatment of allergies, chronic medical conditions, and migraine headaches can be taken during this study (with the exception of opioids for acute treatment of migraines). HV must be on a stable dose of medication for chronic migraines or preventative therapy for at least 1 month at prescreening. HV on stable doses of antidepressants (i.e., for the 3 months prior to prescreening) will be allowed to participate in the study.
排除标准
- •Participant has a history of diverticulitis, intestinal obstruction, stricture, toxic megacolon, GI perforation, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (eg, aortoiliac disease)
- •Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial a. current evidence of laxative abuse or history of drug abuse. b. current (within 14 days of randomization) or expected use of any narcotic or opioid containing agents, docusate, enemas, GI preparations (including antacids containing aluminum or magnesium, antidiarrheal agents, antinausea agents, antispasmodic agents, bismuth, or prokinetic agents) (see 5.3 prohibided concomitant medication). c. Intake of drugs that interfere with the GI motility and fluid balance for 1 month prior to the investigation (see 5.3 prohibided concomitant medication). d. Consumption of grapefruit (juice) or medication that interferes with Naloxegol (CYP3A4 inducers/blockers).
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive
- •Participation in an interventional Trial with an investigational medicinal product (IMP) or device within 30 days prior to randomisation, or is currently enrolled in an investigational study
- •HV has a history of malignancy within 5 years before prescreening (except squamous and basal cell carcinomas and cervical carcinoma in situ).
- •Subjects known to be ultrarapid metabolizers of CYP2D6
- •Participant has an unstable renal, hepatic, metabolic, or hematologic condition
- •Smoking on the day of the investigation and the day prior to it.
- •Non-removable piercings or metal implants
- •Known allergy towards the study medication
- •Participant has any of the following surgical history: a. Any abdominal surgery within the 3 months prior to prescreening; b. History of major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy more than 3 months earlier are allowed).
- •Participant has asthma
- •Participant has a history of a cardiovascular event, including stroke, myocardial infarction, congestive heart failure, or transient ischemic attack within 6 months prior to prescreening
- •Any other disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol
结局指标
主要结局
investigation of the effect of the 3 drug-arms (placebo+placebo, naloxegol+codeine, placebo+codeine) on both colonic motility and segmental colorectal volumes at baseline, after an oat porridge meal and after bisacodyl administration
investigation of the effect of the 3 drug-arms (placebo+placebo, naloxegol+codeine, placebo+codeine) on both colonic motility and segmental colorectal volumes at baseline, after an oat porridge meal and after bisacodyl administration
次要结局
未报告次要终点
研究者
Jan Tack
Scientific
UZ Leuven
研究点 (1)
Loading locations...
相似试验
招募中
1 期
Neoadjuvant ADT with TULSA2022-502067-38-00Turku University Central Hospital15
尚未招募
不适用
Mechanisms Underlying SGLT2i Kidney Effect in DKD ProgressionNCT07270198Mario Negri Institute for Pharmacological Research100
已完成
1 期
A Study to Evaluate the Effect of Single Oral Dose of Balinatunfib on Cardiac Repolarization in Healthy Adult Participants.NCT07272629Sanofi48
招募中
3 期
A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)Cold UrticariaNCT07266402Celldex Therapeutics240
招募中
1 期
Double-blind, randomized, placebo-controlled pilot clinical trial to evaluate the safety, tolerability and efficacy of two doses of a conditioned medium from a co-culture of M2 macrophages and fat-derived mesenchymal cells (PRS CK STORM) in the modulation of the cytokine storm for the treatment of acute respiratory distress syndrome (ARDS) caused by SARS-Cov-2, influenza A, influenza B and respiratory syncytial virus (RSV)2023-507700-32-00Peaches Biotech S.L.50