EUCTR2014-003250-13-CZActive, not recruitingPhase 1
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy, Safety, and Tolerability of Velusetrag for the Treatment of Diabetic or Idiopathic Gastroparesis - The Diabetic and Idiopathic Gastroparesis Efficacy, Safety, and Tolerability (DIGEST) Study
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1.Is male or female, 18 to 75 years of age, inclusive, at Screening
- •2. Willing and able to provide written, signed informed consent
- •3. Symptoms of gastroparesis (eg, nausea, early satiety, fullness, bloating, upper abdominal pain, retching or vomiting) for at least 3 months prior to Screening
- •4. Composite score =2.5 and <5 on nausea, bloating, feeling excessively full after meals, and not able to finish a normal-sized meal items (on the GCSI-2W) at Screening
- •5. At least two of the four symptoms (ie, nausea, bloating, feeling excessively full after meals, and not able to finish a normal-sized meal) with a score =3 (on the GCSI-2W) at Screening
- •6. Delayed gastric emptying, defined as a gastric emptying retention >10% at 4 hours, as measured by 99mTc gastric emptying scintigraphy (GES)
- •7. Body Mass Index (BMI) between 18 and 35 kg/m2, inclusive
- •8. Screening ECG with a QTcF in the normal range (males =450 msec and females =470 msec)
- •9. Upper gastrointestinal obstruction ruled out by endoscopy or other imaging (eg, computed tomography) after the onset of gastroparesis symptoms
- •10. Stable concomitant medications, in particular those that may affect gastroparesis symptoms, for at least 3 weeks prior to Screening. Subjects must be willing to continue these medications without changes throughout the study. Routine adjustments in daily insulin treatment are permitted.
- •11. Willing to abstain from prohibited medications, including but not limited to, anticholinergics, acetylcholinesterase antagonists, or promotility medications (eg, metoclopramide, domperidone, prucalopride, erythromycin) for 72 hours prior to GES during Screening, if applicable, and 72 hours prior to start of the Baseline period and then throughout the duration of the study
- •12. For women of childbearing potential, documentation of a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1.
- •All females are considered to be of childbearing potential unless they are postmenopausal (ie, amenorrheic for at least 2 years) or documented to be surgically sterile (eg, bilateral tubal ligation or total hysterectomy).
- •13. For a sexually active subject: is willing to use an acceptable method of contraception during the study and for at least 2 weeks after completion of study drug dosing
- •14. Able to communicate effectively with the investigator and comply with all study requirements, restrictions, and directions of the clinic staff.
- •Additional Inclusion Criteria for Randomization into Treatment Period:
- •The Baseline Period can last up to 5 weeks and be no less than 7 days (the start of the Baseline Period (Visit 2) may be combined with the Screening Visit). In cases when the Baseline Period is longer than 7 days, the last consecutive 7 days prior to Day 1 will be used to determine eligibility for randomization. Subjects who meet the following additional criteria after the Baseline Period will be eligible for randomization:
- •15. GCSI-DD 7-day mean composite score =2.5 and <5 at Day 1
- •16. Electronic diary completion compliance of at least 5 days per week during the 7 days of the Baseline Period, measured by completion of the GRS and GCSI-DD
- •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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
Exclusion Criteria
- •1. Have received velusetrag in a prior clinical trial
- •2. Acute severe gastroenteritis within 2 weeks prior to Screening
- •3. If Type 1 or Type 2 diabetic, a glycosylated hemoglobin (HbA1c) level >10%
- •4. History of gastric outlet obstruction
- •5. Prior history of gastric surgery, including but not limited to gastrectomy, gastric bypass, gastric banding, pyloroplasty, vagotomy, or fundoplication, which has manipulated the natural anatomy of the stomach
- •6. History of intrapyloric botulinum toxin injection within 6 months of Screening or currently has functioning implantable electric stimulator
- •7. Recurrent and unremitting vomiting, defined as 2 or more vomiting episodes per day for 4 or more days per week
- •8. Pronounced dehydration, in the opinion of the investigator
- •9. Hospitalization for treatment of gastroparesis or a complication of diabetes (eg, hyperglycemic coma, ketoacidosis) within 4 weeks of Screening
- •10. History of eating disorder (eg, anorexia nervosa, bulimia) prior to Screening
- •11. Presence of thyroid dysfunction not controlled by treatment. Subjects with abnormal thyroid stimulating hormone (TSH), hypothyroidism, or hyperthyroidism at Screening unless adequately treated.
- •12. Known secondary causes of gastroparesis, including but not limited to Parkinson’s Disease, cancer, viral illness, or connective tissue diseases.
- •13. Subject is unwilling to abstain from smoking and/or alcohol on the morning of and throughout testing on days when a 99mTc GES or 13C-octanoate GMBT is performed
- •14. Subject is unwilling or unable to perform any gastric emptying tests (eg, allergic to eggs or gluten)
- •15. Bilirubin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine transaminase (ALT), or creatinine levels >1.5 times the upper limit of normal at Screening; or hemoglobin <10 g/dL at Screening
- •16. Use of a prohibited medication, including but not limited to, opioids, linaclotide, or lubiprostone within 2 weeks prior to Screening and throughout the duration of the study
- •17. Received strong CYP3A4 inhibitors (eg, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, grapefruit juice) or strong CYP3A4 inducers (eg, rifampin, rifabutin, rifapentin, dexamethasone, phenytoin, carbamazepine, phenobarbital, St. John's wort) within 2 weeks prior to Screening and throughout the duration of the study.
- •18. Received strong or moderate P-glycoprotein (P-gp) transporter inhibitors (eg, ritonavir, cyclosporine) within 2 weeks prior to Screening and throughout the duration of the study
- •19. Use of 2 or more psychotropic medications within 2 weeks prior to Screening and throughout the duration of the study
- •20. Active treatment for cancer or malignancy (other than non-melanomatous skin cancer) within 1 year prior to Screening
- •21. Participation in an investigational study, involving an investigational drug, within 30 days prior to Screening or approximately five half-lives of the investigational drug if half-life is known, whichever occurs later, or has need of any investigational agent before completion of all scheduled study evaluations
- •22. Presence of disease states that would affect safety and efficacy evaluation, such as cardiovascular disease (eg, acute coronary syndrome, acute myocardial infarction or life-threatening tachyarrhythmia within 3 months prior to Screening), respiratory (eg, requires oxygen), hepatic (eg, cirrhosis, or evidence of clinica
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