EUCTR2005-004155-35-GB进行中（未招募）1 期
A randomized, double blind, parallel group study to examine the effect of multiple doses of CJ-040,714 on distal esophageal acid exposure an patients with erosive gastro-esophageal reflux disease (GERD). - N/A
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Male or female (non-child bearing potential) subject aged 18 to 70 years inclusive.
- •2. A previous diagnosis of gastro-esophageal reflux disease by positive upper GI endoscopy (Los Angeles grade A, B or C)9 within 5 years of screening.
- •3. Active GERD as defined by a positive 24-hour pHmetry test at baseline. Positive is defined as having an esophageal pH of < 4 for > 5 % of the time.
- •4. Body Mass Index (BMI) of approximately 18 to 32 kg/m2; and a total body weight within the range of 40 to 120 kg.
- •5. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.
- •6. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subjects with a history of significant cardiovascular disease, e.g. ischemic heart disease, arrhythmias, QT prolongation, MI or stroke.
- •2. Subjects with a resting BP greater than 170/110 mmHg or less than 90/50 mmHg.
- •3. Subjects with a significant history of symptomatic postural hypotension or greater than a 20 mmHg drop in systolic or 10 mmHg drop in diastolic blood pressure on standing at screening.
- •4. Subjects with previously diagnosed renal impairment. Subjects with creatinine values > 2x ULN and/or with a significant change to their normal values should be excluded.
- •5. Subjects with previously diagnosed hepatic impairment. Subjects with liver function tests > 2 x ULN and/or with a significant change to their normal values should be excluded.
- •6. Subjects with a history of esophageal strictures.
- •7. Subjects with a history of esophageal dysmotility syndromes such as achalasia or nutcracker esophagus.
- •8. Subjects with upper GI endoscopic scoring of Los Angeles grade D.
- •9. Subjects with symptoms of dysphagia.
- •10. Subjects currently being treated for active gastric or duodenal ulceration.
- •11. Subjects diagnosed with Barrett’s esophagus.
- •12. Subjects that have had a surgical treatment for GERD, e.g. fundoplication.
- •13. Subjects with any condition possibly affecting drug absorption (e.g. gastrectomy).
- •14. Subjects with a history or presence of esophageal or gastric neoplasms.
- •15. Subjects with a history of allergic disease (including drug allergies, but not untreated or treated seasonal allergies or mild asthma/eczema).
- •16. Subjects with a positive urine drug screen.
- •17. Subjects who have a history of regular alcohol consumption exceeding 21 drinks per week (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of spirits) within 6 months of screening.
- •18. Subjects who have received treatment with an investigational drug within 4 months preceding the first dose of study medication.
- •19. Subjects who are unable or unwilling to withdraw from acid suppressing (e.g. proton pump inhibitors or H2 receptor antagonists), gastro-prokinetic or other drugs for the treatment of GERD for the duration of the study (including the 7 days prior to the baseline pHmetry test).
- •20. Subjects who are taking or have taken within 14 days of dosing any drugs that are known to be potent CYP3A4 inhibitors (e.g. ketoconazole, erythromycin, clarythromycin).
- •21. Subjects taking b-blocker agents within 28 days of first dose.
- •22. Subjects with a screening 12-lead ECG demonstrating any of the following: heart rate >120 bpm, QRS duration >120 msec, QTc interval >430 msec, PR interval >210 msec, any clinically significant rhythm abnormality, any evidence of myocardial ischemia or injury.
- •23. Subjects that have made a blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
- •24. Subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia.
- •25. Subjects with any clinically significant laboratory abnormalities that may increase the risk associated with trial participation or may interfere with the interpretation of the trial results.
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