This study will be performed in healthy volunteers.
Conditions
Interventions
Trade Name: Moventig
Product Name: Moventig
Pharmaceutical Form: Tablet
INN or Proposed INN: Moventig
CAS Number: 854601-70-0
Other descriptive name: NALOXEGOL
Concentration unit: mg milligram(s)
Conc
Sponsors
KU Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. HV is a man or woman aged 18 to 65 years , inclusive, at prescreening. 2. 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. 3. HV has not used any opioid medication 14 days prior to randomization. 4. 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. As needed use of benzodiazepines, if habitual, is permitted. 5. Female subjects must either be: a. postmenopausal, defined as 52 years or older and amenorrheic for at least 2 years at prescreening, b. surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), c. abstinent, or d. if sexually active, be practicing an effective method of birth control such as hormonal prescription oral contraceptives, progesterone implants or injections, contraceptive patch, intrauterine device, or male partner with a vasectomy. 6. HV must sign an informed consent document before the initiation of any study-related procedures indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study. 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 15 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. HV has a history of inflammatory or immune-mediated GI disorders including inflammatory bowel disease (ie, Crohn’s disease, ulcerative colitis), celiac disease and functional bowel disorder. 2. HV has a history of diverticulitis. 3. HV has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (eg, aortoiliac disease). 4. HV has any of the following surgical history: a. Any abdominal surgery within the 3 months prior to prescreening; b. HV has a history of major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post-surgery are allowed). 5. HV has current evidence of laxative abuse. 6. HV has a history of a cardiovascular event, including stroke, myocardial infarction, congestive heart failure, or transient ischemic attack within 6 months prior to prescreening. 7. HV has an unstable renal, hepatic, metabolic, or hematologic condition. 8. HV has a history of malignancy within 5 years before prescreening (except squamous and basal cell carcinomas and cervical carcinoma in situ). 9. HV has abnormal thyroid function test as confirmed by thyroid-stimulating hormone <0.3 mcIU/mL or =5 mcIU/mL at Prescreening. However, patients who are clinically euthyroid due to thyroid supplement are candidates for the study. 10. HV has 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). 11. HV has received an investigational drug or used an investigational medical device within 30 days prior to randomization, or is currently enrolled in an investigational study. 12. HV is pregnant or breastfeeding. 13. HV has any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the HV from meeting or performing study requirements. 14. No smoking on the day of the investigation and the day prior to it. 15. No consumption of grapefruit or grapefruit juice because it can increase Naloxegol plasma levels.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to compare the effects of Naloxegol compared to placebo on colonic motility, in combination with the presence or absence of a mu-opioid agonist, codeine. This will be investigated in HVs using high-resolution colonic manometry. Our objective is to correlate colonic motor patterns or a decrease in overall colonic motility to the symptoms in opioid induced constipation.;Secondary Objective: Not applicable. ;Primary end point(s): - The primary outcome variable is the overall prevalence of anterograde colonic motor patterns in the different treatment categories.;Timepoint(s) of evaluation of this end point: End of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Evaluation of the overall prevalence of the other colonic motor patterns (retrograde propagating sequences, simultaneous pressure waves, cyclic propagating sequences, high-amplitude propagating sequences) - Evaluation of the overall prevalence of high-amplitude propagating sequences after Bisacodyl - Evaluation of the colonic motility index in the left, right and sigmoid colon. - Percentage of Participants reporting Adverse Events (AE). ;Timepoint(s) of evaluation of this end point: End of the study. | — |
Countries
Belgium
Contacts
Public ContactMedical doctor
KU Leuven
Outcome results
None listed